The aim of this study is to compare the effects of %4 articaine and %2 lidocaine on inferior alveolar nerve block (IANB) for implant surgery in the posterior mandible. The patients who have inserted implants in the posterior mandible were divided into 2 groups for IANB: lidocaine and articaine. VAS = visual analog scale, pain during surgery and injection, lip numbness time, mandibular canal-implant apex distance, age, gender, bone density, implant number, release incision, adjacent teeth, and duration of surgery were analyzed using t-test, Mann-Whitney U test, Spearman's coefficient, and, Pearson's chi-squared test. This trial followed the recommendations of the Consort Statement for reporting randomized controlled trials.p>0.05). The lip numbness time of lidocaine was 3.06±3.22min while articaine was found to be 2.96±3.09min (p>0.05). Mandibular canal-implant apex distance was found to be 2.28±0.75mm in the articaine and 2.45±0.86mm in the lidocaine group (p<0.05). Release incision was made more in the articaine group (51/252) than in the lidocaine group (40/325) (p<0.05). 577 patients were included and 1185 dental implants were analyzed. There was no significant difference between the two groups in terms of injection and surgery VAS values ( There was no difference between the %4 articaine and %2 lidocaine in terms of pain perception in posterior mandible implant applications. Both anesthetics provided adequate anesthesia for implant application. Key words:Articaine, dental implant, lidocaine, local anesthesia, mandibular nerve, pain perception. A localet al  stated tl . All procedures performed in this study comply with the ethical standards of the institutional and/or national research committees and the 2013 Declaration of Helsinki and its subsequent amendments or comparable ethical standards. A normal healthy patients and patients with mild systemic disease were included the study. Patients who have any hormonal condition, who use any medication, who need further surgery that can change the perception of pain, and who will be sedated because they cannot indicate pain perception, were excluded from the study.Inclusion Criteria:1) Patients with systematic conditions are classified as ASA Class I and Class II .2) The patients who need one implant at least due to posterior mandibular tooth loss at least 2mm distal to the mental foramen.Exclusion Criteria:1) Pregnancy, lactation, and taking contraceptive pills.2) Oversensitivity or anaphylactic reactions which contraindicate the intervention.3) Orofacial neurological symptoms.4) Infections at the operation zone.5) Psychotropic medicine, sedative, or NSAI use which can alter the sense of pain.6) Pathological mental conditions  and lack of cooperation.7) Advanced surgical necessities 8) Operations carried out with conscious sedation.9) Patients who do not want to sign consent.Participants were randomly assigned to one of the 2 treatment groups (lidocaine and articaine) following a simple software-generated random number procedure via the “List Randomizer” application (https://www.random.org.lists). The primary outcome of the study was to measure the patients’ perception of pain during anesthesia administration and surgery, using a numerical rating scale (VAS) from 0 (no pain) to 10 (the worst pain imagine) ,14. Pote- InterventionsThe first group was administered 40mg/ml articaine hydrochloride and 0.006mg/ml epinephrine hydrochloride , and the second group was applied 20mg/ml lidocaine hydrochloride and 0.0125 mg/ml epinephrine based anesthesia . In both groups, operations took less than 60 minutes after the anesthesia. Procedures that lasted longer than 60 minutes and procedures that required advanced surgical applications for implant surgery were excluded from the study. Periosteal integrity was tried to be maintained but the patient’s periosteal integrity which could not be maintained was noted. IANB was applied via a 2 ml capacity 27-G 50 mm standard dental syringe. The patient’s mouth was opened as much as possible so that the raphe pterygomandibularis between the musculus buccinator and musculus constrictor pharynges superior could be seen clearly. From the front edge of the ramus mandibularis, the overlying soft tissue was removed via a mouth mirror. The needle was pushed to the slightly lateral part of the middle zone of the pterygomandibular raphe and contacted the bone.Then it was slightly pulled and aspirated, and the anesthetic agent was injected. To the participants of both groups, all of the anesthetic agents in the ampoule were injected. Following the injection, if numbness could not be achieved in the lips, a second injection was applied. No extra INF was applied to the buccal zone. Upon achieving adequate numbness, a standard implant placing procedure was followed. With the purpose of exposing the bone, the mucoperiosteal flap was elevated and the zone in which the implant would be placed was drilled at 800-1200 rpm and cooled with saline in accordance with the producer company’s guidelines. Then the implants were screwed to the bone with a pressure of 35nm of torque. Following this step, flaps were primarily closed via 4/0 non-absorbable monofilament polypropylene sutures .- Data Analysisp<0.05 for all tests.With the purpose of reaching reliability power and confidence levels of 95% and to be able to calculate the pain strength at around d = 0.50, the size of the sample was thought to be 184 patients at least 92 patients per group . Shapirop=0.778)  (p=0.678). When the proximity of the mandibular canal was measured, the distance was found to be 2.28±0.75mm in the articaine group and 2.45±0.86mm in the lidocaine group . While 25 (9%) patients needed a second injection in the articaine group, the number of patients who needed a second injection in the lidocaine group was 32 (9%). 577 participants were included in the study and these participants have applied for 1185 dental implants. 43.7% (252 patients) of the participants were in the articaine group while the lidocaine group consisted of 56.3% (325 patients) of the patients . The avep=0.302) , Fig. 2.ne group . Althougp=0.001). Furthermore, a positive correlation was discovered between the increase in the duration of anesthesia and the pain felt during surgery . In the articaine group, a positive correlation was determined between those who felt pain during anesthesia and those who felt pain during operation .When the correlation of the variables was analyzed, a positive correlation was found between those who felt pain during anesthesia and those who felt pain during surgery in the lidocaine group  to obtain IANB on the posterior mandible. According to the results of the study, both during the administration of anesthesia and during the operation with patients who underwent IANB, there was no significant difference in terms of pain perception between the two groups. Although the distance to the mandibular canal was significantly reduced in the articaine group and significantly more releasing incisions were applied to these patients, they did not differentiate patients' perception of pain between the two groups. Besides, the amount of the felt pain did not differ in accordance with the bone type. Both anesthetic agents which were used in IANB that were applied for implant placement in the posterior mandible were equally effective. Considering the factors which can affect the perception of pain, there was not any significant difference between the groups in terms of age, gender, and the number of placed implants. The factors affecting the duration of anesthesia are intrinsic properties of the anesthetic agent and method and are directly affected by the pKa value – a smaller pKa value is associated with a shorter delay. pKa value of 4% articaine solution is 7.8 . The valet al , 1.66 mil . However, groups did not show any differences in terms of pain perception after 5, 15, 30, and 60 minutes following the anesthesia. In our study, during and after the anesthesia, there was not any difference between the groups. This may stem from the difference in the applied IANB method or the dentist applying it. During the anesthesia, which is applied so close to the bone, the possibility of feeling pain may increase. In our study, it was found that the patients who felt pain during anesthesia also felt pain during the operation. In line with ethical frameworks, the operation cannot be continued even though patients feel pain. Pain perception can vary from person to person. Some people are more sensitive to pain, so they focus on the pain and feel it more as a consequence. Because IAN is both a motor and a sensory nerve by nature, it is essential in enabling people to interact with the environment because they provide sensations of touch, pressure, temperature change, and pain (When the studies comparing the efficiency of the anesthetic agents are evaluated, it can be seen that there is no consensus in the literature. Since implant surgery is performed with sensitive measurements, IANB anesthesia was preferred in our study as the patient’s pain can affect the surgeon’s performance. In a meta-analysis, it was reported that a 2% lidocaine injection in third molar surgery provided a higher VAS score than a 4% articaine injection . In a stet al  comparedet al . In the l (et al  comparedl (et al  performel (et al  tested tand pain . Therefoand pain . Meechanet al (Epinephrine is commonly added to local anesthetic solutions to induce vasoconstriction at the injection site. Addition of epinephrine increases local anesthetic activity by antagonizing the natural vasodilator effects of most local anesthetics, in addition to the vasoconstrictive effects provided by α-1 adrenoceptors. Moore et al  investiget al . In our According to the results of the study, there is no difference between groups when VAS scale results are evaluated for 4% articaine and 2% lidocaine in terms of IANB which is utilized with the purpose of providing adequate anesthesia in posterior mandible implant surgeries.


The aim of this study is to explore the clinical characteristics in chronic rhinosinusitis with nasal polyps (CRSwNP) patients with different serum specific IgE (SIgE) and eosinophilic granulocyte infiltration status.p < .001), endoscopic score (p = .014), computerized tomography (CT) score (p < .00) and the sino‐nasal outcome Test‐22 (SNOT‐22) score (p < .001) were significantly different among patients with SIgE‐positive combined eosinophilic chronic rhinosinusitis (ECRS), patients with SIgE‐positive combined non‐ECRS, patients with SIgE‐negative combined ECRS, and patients with SIgE‐negative combined non‐ECRS.This retrospective observational study included patients diagnosed with CRSwNP and underwent functional endoscopic sinus surgery at the Yinchuan First People's Hospital between June 2019 and June 2021. A total of 192 patients with CRSwNP were included . The patients were 41.7 ± 15.1 years old. The disease course ranged 4.6–18.2 months. The visual analog scale (VAS) score (p < .0083). The VAS score, endoscopic score, and CT score might be higher in CRSwNP patients with SIgE‐positive combined ECRS.In pairwise comparison, the VAS score , endoscopic score , CT score , and SNOT‐22 score  was significantly higher in patients with SIgE‐positive combined ECRS compared to patients with SIgE‐positive combined non‐ECRS, patients with SIgE‐positive combined non‐ECRS  Patients with CRSwNP were included in the study, including 100 males and 92 females. Positive SIgE was found in 105 cases. Among the 105 SIgE‐positive patients, 41 had ECRS, and 64 had non‐ECRS CRSwNP. Among the 87 SIgE‐negative patients, 33 had ECRS, and 54 had non‐ECRS CRSwNP. There were no significant differences (p=.290) between the two groups (A). There was no significant difference in age, sex, endoscopic score, CT score, serum eosinophil count between the two groups (p > .05), but the VAS score was significantly higher in the SIgE‐positive group compared with the SIgE‐negative group (■p < .001) (B).F I G U R E 1 (p < .001), endoscopic score (p = .014), computerized tomography (CT) score (p < .001) and SNOT‐22 score (p < .001) were significantly different among groups. In pairwise comparison, the VAS score, endoscopic score, CT score, and SNOT‐22 score was significantly higher in patients with SIgE‐positive combined ECRS compared to patients with SIgE‐positive combined non‐ECRS, patients with SIgE‐positive combined non‐ECRS (p < .0083). And patients with SIgE‐negative combined ECRS have significantly higher CT score compared to patient with SIgE‐positive combined non‐ECRS and SIgE‐negative combined non‐ECRS.F I G U R E 2 Four groups were defined according to ECRS and SIgE: SIgE‐positive combined ECRS, SIgE‐positive combined non‐ECRS, SIgE‐negative combined ECRS, and SIgE‐negative combined non‐ECRS. VAS score ( Previous case‐control studies suggested a possible role of food allergy in CRSTherefore, this retrospective observational study aimed to explore the clinical characteristics in CRSwNP patients with different SIgE and eosinophilic granulocyte infiltration status.22.1wNP and underwent functional endoscopic sinus surgery at the ENT & HN Surgery Department of the Yinchuan First People's Hospital between June 2019 and June 2021. This study was approved by the Ethics Committee of the First People's Hospital of Yinchuan City. The requirement for individual consent was waived by the committee because of the retrospective nature of the study.This retrospective observational study included patients diagnosed with CRSThe diagnostic criteria were in line with the Chinese Guidelines for the Diagnosis and Treatment of Chronic Rhinosinusitis (2018).wNP, (3) underwent functional endoscopic sinus surgery, and (4) available SIgE data. The exclusion criteria were (1) used systemic glucocorticoids 2 weeks before the surgery, (2) history of nasal or sinus tumors, (3) orally taking antihistamines, (4) fungal sinusitis, or (5) combined with rheumatoid disease.The inclusion criteria for the study were (1) >18 years of age, (2) diagnosed with CRS2.2The demographic information (including age and sex) and clinical characteristic  were collected.The SIgE test results before surgery were collected. The semi‐quantitative detection unit of specific allergen IgE was IU/mL, and the grades were classified into: grade 0, normal, <0.35; grade 1, mild, 0.35–0.7; grade 2, moderate, 0.7–3.5; grade 3, severe, >3.5. Grade 0 was considered negative, and grades 1–3 were considered positive.The subjective symptoms of rhinosinusitis  of all the patients before surgery were scored using a VAS score. The range from 0 to 10 represented symptoms gradually aggravating.wNP.The eosinophilic granulocytes in the nasal polyp tissue of the enrolled patients after surgery were counted. If the count was ≥10/HPF, it was defined as ECRS, and if the count was <10/HPF, it was defined as non‐ECRS CRSThe Lund‐Mackay CT scoreThe Lund‐Kennedy scoreSNOT‐202.3p < .05 were considered statistically significant.SPSS 14.0 (SPSS Inc.) was used for statistical analysis. The continuous data was tested for normal distribution by Kolmogorov–Smirnov test and tested for homogeneity of variance by Levene's test. All continuous data confirmed to normal distribution and are expressed as means ± standard deviation and were compared by one‐way analysis of variance test, and Bonferroni's post hoc test was used for pairwise comparisons between groups. Two‐sided 3wNP were included in the study, including 100 males and 92 females. The patients were 18–64 years old, with an average age of 41.7 ± 15.1 years, and the courses of disease ranged from 4.6 to 18.2 months. Positive SIgE was found in 105 cases (54.7%). There was no significant difference in age, sex, endoscopic score, CT score, serum eosinophil count, and ECRS between the two groups (p > .05), but the VAS score and SNOT‐22 score was significantly higher in the SIgE‐positive group compared with the SIgE‐negative group   between the two groups , endoscopic score (p = .014), CT score (p < .001) and SNOT‐22 score (p < .001) were significantly different among groups. In pairwise comparison, the VAS score , endoscopic score , CT score , and SNOT‐22 score  was significantly higher in patients with SIgE‐positive combined ECRS compared to patients with SIgE‐positive combined non‐ECRS, patients with SIgE‐positive combined non‐ECRS . And patients with SIgE‐negative combined ECRS have significantly higher CT score compared to patient with SIgE‐positive combined non‐ECRS and SIgE‐negative combined non‐ECRS  are aggravated even in the absence of significant differences in CT and endoscopic scores. Szucs et al.wNP and the difficulty in treatment are positively related to the infiltration of eosinophilic granulocyte in the tissue but not related to the patient's allergic constitution, which contradicts the present study. On the other hand, Collins et al.At present, it is generally believed that the detection of SIgE or laboratory‐specific IgE is safer and more reliable than the skin‐prick test and is the best indicator for the diagnosis of allergy or allergy‐related diseases.wNP patients cannot provide a conclusion about the allergy status. It is currently believed that the increased number and degree of infiltration and aggregation of eosinophilic granulocyte is related to the eosinophilic chemokines released by basophilic granulocyte or mastocyte at the site of allergy.wNP patients with allergy and without allergy. Snidvongs et al.wNP patients have allergic reactions. It suggests that the relationship between the general allergic reaction status and the degree of infiltration and activation of eosinophilic granulocyte in local tissues is uncertain.wNP patients does not induce an inflammatory response of eosinophilic granulocyte in the nasal polyps, but there is an independent pathophysiological mechanism of inflammation maintenance.Snidvongs et al.wNP patients, the combination of allergic reaction and ECRS could aggravate the subjective symptoms and the objective physical signs of CRSwNP, thus Reducing the quality of life of patients with of CRSwNP. Kowalik et al..In this study, patients in the SIgE‐positive group with ECRS had significant differences compared with the other groups in terms of the subjective score of VAS symptoms and the objective scores of Lund‐Mackay CT, Lund‐Kennedy physical signs, and SNOT‐22 score indicating that in CRSFor the treatment of CRSwNP, at present, it mainly depends on nasal endoscopic surgery and local or systemic drug treatment, such as glucocorticoids and macrolides; CRSwNP is associated with Th2 type inflammation and immune hypersensitivity comorbiditieswNP. The relationship between local tissue IgE and eosinophilic granulocyte has not been established. Third, the impact mechanism of allergy on CRS needs to be further explored.This study is a retrospective study and has some limitations. First, the sample size was relatively small. Second, various prediction methods have advantages and disadvantages, and there is a lack of mature prediction methods for CRSIn conclusion, the VAS score, endoscopic score, and CT score might be higher in CRSwNP patients with SIgE‐positive combined ECRS.Conception and design: Jingmin Hu; data curation: Jingmin Hu; formal analysis and visualization: Le Wang; investigation: Le Wang; writing, original draft: Jingmin Hu and Ruixia Ma; All authors read and approved the final manuscript.The authors declare no conflicts of interest.This study protocol was reviewed and approved by the First People's Hospital of Yinchuan City . The requirement for individual consent was waived by the committee because of the retrospective nature of the study.


Cardiovascular diseases cause the death of 17.5 million people every year. Cardiac catheterization is an invasive diagnostic exam that allows treatment followed by the examination and can cause some complications such as pain. From this perspective, music has alleviated suffering and promoted pain relief for patients. This study aims to evaluate the effectiveness of music therapy to relieve pain in adults and older adults during femoral arterial sheath removal after cardiac catheterization.This is a randomized controlled clinical trial, with two arms and a single-blind design to be carried out with 68 patients equally allocated into control and experimental groups. The intervention will be applied with the use of headphones without any musical transmission in the control group or with the patient’s musical preference in the experimental group with sound intensity of 60 dB. These patients will be evaluated in three moments: immediately before, during and 15 min after the painful procedure. The primary outcome includes reduction of pain intensity verified by the Visual Analogue Scale and the secondary outcome corresponds to improvement of vital signs and vocal and facial pain expressions.This study will allow by testing a non-pharmacological strategy to relieve pain during femoral sheath removal after cardiac catheterization, having its parameters evaluated at three moments: immediately before (30 min), during the procedure and 15 min after the painful procedure. It also enables the use of a low-cost, potentially effective resource that makes nursing care more humanized by improving user satisfaction with the service provided, in addition to reducing the need for post-procedure analgesics.This study is registered on the Brazilian Clinical Trials Registry (REBEC) platform under number RBR-3t3qwp7 (05/04/2022) and was approved by the Research Ethics Committee of the Federal University of Rio Grande do Norte under CAAE 52,586,521.8.0000.5537 (11/11/2021). Cardiovascular diseases (CVD) are the leading cause of death worldwide, causing the death of 17.5 million people every year according to the World Health Organization (WHO) .Acute coronary diseases are diagnosed through electrocardiogram examination, analysis of clinical signs and cardiac enzymes and are confirmed by hemodynamic evaluation, cardiac catheterization. Also known as coronary angiography or cine-angiography, cardiac catheterization is an invasive diagnostic test performed to analyze coronary vessels or heart muscles through the insertion of catheters by arterial puncture in the arms or legs to reach heart chambers. Thus, this therapeutic approach provides accuracy in anatomical and functional visualization, which allows the treatment to be carried out followed by the examination .It was observed that the establishment of more elaborate processes in hemodynamics laboratories enables the appearance of complications in patients undergoing endovascular procedures. Among them, those that stand out most frequently are pseudoaneurysms, hematomas, distal embolization, bleeding at the insertion site, and arterial thrombolysis . HoweverPain is related to both a sensory and an emotional experience . In thisThe measurement of this phenomenon can be performed through the use of scales to assess pain in adults, namely: non-verbal pain scale (NVPS), critical care pain observation tool (CPOT), behavioral pain scale (BPS), behavioral pain assessment tool (BPAT), pain assessment tool (PAT) and COVERS scale, behavioral pain indicators scale (ESCID) . The VisIt is up to the nurse to assist in pain management throughout the nursing process, using to assess pain, pharmacological and non-pharmacological therapies and the control of patient responses. Thus, the implementation of non-pharmacological strategies is considered as complementary, helping to relax, improve sleep patterns and relieve pain . Thus, nThe use of music therapy also collaborates in the therapeutic treatment with physiological effects related to changes in metabolism, regulation of respiratory rate, release of adrenaline, variations in Blood Pressure (BP), reduction of fatigue and increase in sensory stimuli. Therefore, it is an accessible therapeutic tool, easy to use, with no side effects, allowing wide use in different therapeutic scenarios . From thp < 0.05) after 30 min of musical intervention, when compared with results using the same scale before intervention and when comparing the experimental group with the other study groups: rest without music and standard service care [Similarly, a retrospective study carried out with 99 patients in China sought to evaluate the effects of music on anxiety, pain and depression of patients after coronary artery bypass graft surgery. The research describes significant reduction in the numerical pain scale (ice care .p < 0.05) have been reported in reducing anxiety and the physiological parameters associated with it, and it is therefore considered an effective intervention, with no side effects [In addition to these important variables, a quasi-randomized Controlled Clinical Trial described the effects of natural sounds on anxiety and physiological parameters such as systolic, diastolic and mean blood pressure, Heart Rate (HR) and oxygen saturation in 130 subjects undergoing coronary angiography. Positive and statistically significant results  of pain in these patients?To evaluate the effectiveness of music therapy to relieve pain in adults and older adults during femoral arterial sheath removal after cardiac catheterization.This study is registered on the Brazilian Clinical Trials Registry (REBEC) platform under number RBR-3t3qwp7 (05/04/2022) and was approved by the Research Ethics Committee of the Federal University of Rio Grande do Norte under CAAE 52,586,521.8.0000.5537 (11/11/2021). This protocol complies with the Standard Protocol Items for Randomized Trials (SPIRIT) .This is a protocol of a Randomized Controlled Clinical Trial (RCT) with two arms and single-blind intervention design, which compares the effects of music therapy to relieve pain in adults and older adults during femoral arterial sheath removal after cardiac catheterization with standard interventions already used by the service for this same procedure.The population will be composed of individuals who will undergo cardiac catheterization at the largest hemodynamics service of the state of Rio Grande do Norte, located in Natal, state of Rio Grande do Norte, Brazil, with the need to remove the arterial sheath via the femoral route. The sample will be random and simple probability.The following inclusion criteria will be adopted: patients aged 18 years or older admitted to hemodynamics for elective cardiac catheterization, with the need to remove the arterial sheath via the femoral route. Those who do not like music, who have previously undergone the procedure, those with chronic pain, diagnosis of arboviruses, fibromyalgia, previous analgesia, individuals with neurological and/or cognitive problem that compromise the understanding and use of the scale and individuals with hearing impairment will be excluded. Figure The Control Group (CG) will be composed of 34 patients allocated in a simple random way with clinical indication of performing cardiac catheterization. These patients will receive the standard care already adopted by the service, in addition to the application of headphones without any musical transmission for the removal of the arterial sheath via the femoral route in a timely manner and will remain with the headphones for 15 min after the end of the painful procedure.The Experimental Group (EG), in turn, will be composed of 34 patients allocated in this group in a simple random way, who will receive the same care as the previously mentioned group, in addition to the application of headphones which will transmit the patient's musical preference during the performance of the painful procedure up to 15 min after its completion. The headphones will be used in a complementary way and not as a substitute for the care already adopted by the service.At first, the principal researcher will apply a form previously prepared with participants of both groups containing the following sociodemographic data: date of birth, age, sex, color, marital status, schooling, profession, family income and musical preference.At this time, the initial part of the second previously prepared form will also be applied, containing the following clinical data: comorbidities, reason for performing cardiac catheterization and medications in use. After completing this part, blood pressure, heart and respiratory rate vital signs will be measured, as well as information regarding oxygen saturation, presence or absence of bodily signs and symptoms of pain such as sweating, pallor, vocal or face expression or pain. These data will be recorded in the second previously prepared form and repeated during the intervention and 15 min after the end of the painful procedure.This second form also contains information regarding the French number of the arterial sheath, the professional responsible for removing it, if there were complications during the painful procedure and what these complications were; if there were complications after the procedure and what these complications were; how long the arterial compression lasted after the intervention; if there was need for analgesia after the procedure and the time to receive the hemodynamic discharge. Finally, the Visual Analog Pain Scale will be applied to identify pain intensity.The primary outcome expected is reduction in pain intensity through the Visual Analogue Scale (VAS)  and reduThe secondary outcome expected is absence of bodily signs and symptoms of pain verified through the absence of the following parameters: sweating, pallor and facial expression of pain, in addition to reduction of the intensity levels of vocal expressions of pain, namely: screaming, crying, groaning, verbal report of pain or their absence through the application of the patient's musical preference using headphones during the removal of the arterial sheath via the femoral route after cardiac catheterization.Immediately before carrying out the procedure, the first researcher will recruit the possible subjects and explain the main study objective, the possible risks and benefits involved in the study and emphasize that he/she may withdraw from participating in the research at any stage of it.If there is affirmative answer, this first researcher will apply the inclusion and exclusion criteria to select the individuals who will compose the sample. Then, they will be asked to read and sign the Free and Informed Consent Form (FICF) to guarantee their participation in the study.Table Patients participating in the study will be monitored throughout their stay in the hemodynamic admission/recovery room. In this sense, after carrying out the cardiac catheterization and returning to the aforementioned room, the patient will be approached in an attempt to recruit and select the sample. After applying the inclusion and exclusion criteria, patients will be asked to sign the informed consent form, guaranteeing their participation in the study and allocation to control or experimental groups. At this initial moment, sociodemographic data and the first part of clinical data will already be completed, initiating their follow-up.After the initial 30 min, if the patient's blood pressure is within acceptable limits, the health professional will remove the arterial sheath via the femoral route. At this point, the second part of the instrument referring to clinical data will be completed, continuing the follow-up.Finally, after arterial sheath removal and after 15 min of arterial compression according to the service protocol, the headphones will be removed and the third and last part of the instrument referring to clinical data will be completed and finished with the VAS application for the identification the pain intensity. After performing the compressive dressing, the individual will spend four hours keeping the limb at rest until discharged from the unit, at which time follow-up will be completed.The sample size calculation was performed using the G Power software, version 3.1.9.2, with Cohen effect of 0.50, test power of 0.80 and significance level of 5%, establishing N of 34 patients per group, experimental and control, totaling 68 patients.Patients will be randomly allocated into two groups: Control Group (CG) and Experimental Group (EG). Their allocation will be guaranteed through the “Research Randomizer” website so that all patients have an equal chance of becoming part of one group or another.The study will have the participation and involvement of two researchers. Researcher 1 (R1) will be responsible for the recruitment and initial selection of individuals that will compose the sample, as well as for guaranteeing their participation by signing the Free and Informed Consent Form (FICF), performing the randomization and allocation of patients and application of headphones in both groups. The second researcher will be responsible for applying the data collection instruments during the intervention and at the end of the painful procedure. Thus, the second researcher, service health professionals and patients will not know to which groups patients will be allocated.First, two researchers (R1 and R2) will be trained to perform data collection, in accordance with the study protocol. The information will be collected in the patient's admission/recovery room and stored in database previously built in Microsoft Excel. Subsequently, data will be exported to the Statistical Package for Social Science Version 18.0 software (SPSS Version 20.0) in order to perform descriptive and inferential analyses. Therefore, data will be presented through tables, charts and figures.It is worth mentioning that losses and dropouts will be carefully recorded in order to ensure study reliability. Therefore, whoever withdraws from participating in the research will be replaced by the next participant who meets the inclusion and exclusion criteria, being included in the group referring to the withdrawal until reaching the previously calculated sample number. All information will be stored in a safe place by the responsible researcher for a period of five years and will only be presented in scientific publications, preserving the anonymity of participants.2) or Fisher's Test will also be used. Other tests that may be necessary will also be adopted. Results will be presented through tables, charts and figures, adopting significance level of 5% (p = 0.05).Data will be described in a database previously built in Microsoft Excel and exported to the Statistical Package for Social Science Version 18.0 software (SPSS Version 20.0), where descriptive and inferential analyses will be performed. The Kolmogorov–Smirnov test will be used to assess the normality of variables. For the evaluation of variables, the Chi-square (χCoronary Artery Disease (CAD) has coronary angiography as the gold standard test for its diagnosis , in addiTherefore, randomized clinical trials have used VAS to measure acute and chronic pain intensity after cardiac catheterization. This scale is subjective and graded from zero to ten, with zero representing no pain and ten corresponding to unbearable pain , 20.Music is a strategy that has been used by studies with the purpose of acting in the alleviation of pain and anxiety and improvement of physiological parameters in percutaneous coronary procedures. An RCT was performed in Turkey with 62 patients who would undergo coronary angiography via the femoral route. The music was heard through a CD prepared by a specialist at volume 20 for 45 min before the procedure. This intervention was described as effective, especially in reducing anxiety, diastolic blood pressure, respiratory rate and pain after the procedure. In addition, the need for analgesics and sedation was also reduced in the experimental group .p < 0.05) and pain levels (p < 0.001) were described in the experimental group [However, musical intervention can be used in different ways and be equally effective. Another study conducted at the University of Aksaray Training and Research Hospital, with 171 subjects, used instrumental music with the flute through headphones for about 60 to 80 beats per minute to induce relaxation. This type of music was selected by a specialist in the field and, at the end of the intervention, significant reduction in systolic blood pressure , during the procedure and 15 min after the painful procedure. It also enables the use of a low-cost, potentially effective resource that makes nursing care more humanized by improving user satisfaction with the service provided, in addition to reducing the need for post-procedure analgesics. However, it is limited by being developed in only one university hospital located in Brazil, therefore understanding the reality of this location.This clinical trial was approved by the Research Ethics Committee of the Federal University of Rio Grande do Norte under CAAE 52,586,521.8.0000.5537 (11/11/2021) and CEP 5.100.469 (11/11/2021), in addition to being registered on the Brazilian Registry of Clinical Trials (REBEC) platform under number RBR-3t3qwp7 (05/04/2022).The participation of individuals will be on a voluntary and non-profit basis, being guaranteed through the signature of the FICF. Data provided are confidential and will only be disclosed at conferences or scientific publications, anonymously, without disclosing any information that allows patient identification. Results will be kept by the responsible researcher in a safe place and for a period of 5 years.


The main findings of the study are that pectoralis nerve block II (PECS II) may be a valuable analgesic option that alleviates flap dissection pain and stress during a robot-assisted transaxillary thyroidectomy (RATT) and reduces opioid consumption in the early recovery phase. Patients who received PECS II experienced a more comfortable recovery and required fewer painkillers. PECS II may serve as a valuable new pain relief modality in addition to the multimodal analgesic strategy for patients undergoing RATT. Although we have yet to investigate the optimal block duration, regions of sensory loss, optimal technique, and possible complications, our preliminary study suggests that PECS II reduces flap dissection pain and thus promotes recovery. Appropriate analgesia during RATT remains challenging, but is a key issue for postoperative recovery. A further prospective investigation is required to validate our results and establish the optimal pain control regimen for patients undergoing RATT.p = 0.017 and p = 0.034, respectively). The block group required fewer painkillers in the post-anesthesia care unit than the no-block group, although the difference was not statistically significant in the ward. PECS II may serve as a new pain relief modality and valuable addition to the current multimodal analgesic strategy for patients undergoing RATT.Few studies have examined the clinical utility of ultrasonography-guided pectoralis nerve block II (PECS II) during wide flap dissection of a robot-assisted transaxillary thyroidectomy (RATT). We assessed the ability of PECS II to reduce postoperative pain. We retrospectively reviewed 62 patients who underwent elective RATT from December 2021 to April 2022 at Seoul St. Mary’s Hospital . The patients were divided into a block group  and no-block group . Pain was measured using a visual analog scale (VAS) at 4, 10, 20, 25, 35, and 45 h after surgery, and the requirements for rescue painkillers in the post-anesthesia care unit and ward were recorded. The VAS scores did not differ significantly between the two groups at 4 h postoperatively. The block group had significantly lower VAS scores at 10 and 25 h ( Surgical techniques for thyroid diseases have continuously evolved; prognosis and safety have been improved, and scarring, hospitalization times, and recurrence rates have been reduced. Modifications of operative methods have increased efficacy and reduced invasiveness; open incision was replaced by a videoscope-assisted technique ,2,3. HowRegional thoracic anesthesia/analgesia was typically used for neuraxial epidural or paravertebral block. However, developments in ultrasound guidance led to new myofascial plane block techniques that have greatly aided many surgeries . PreviouTo the best of our knowledge, no study has examined the clinical utility of ultrasonography-guided upper thoracic wall nerve block during wide flap dissection for a robot-assisted transaxillary thyroidectomy (RATT). We investigated whether this block can reduce postoperative pain.This preliminary, retrospective cohort study was conducted in accordance with the Declaration of Helsinki (2013) and approved by the institutional review board of Seoul St. Mary’s Hospital, Catholic University of Korea  ; the board waived the requirement for informed consent given the retrospective nature of the work.We retrospectively reviewed 62 patients (aged ≥ 18 years) who underwent elective RATT  from December 2021 to April 2022 at Seoul St. Mary’s Hospital. The exclusion criteria were American Society of Anesthesiologists physical status III or IV (n = 3), conversion to non-robotic surgery (n = 2), a history of anticoagulation treatment (n = 1), and reoperation because of bleeding (n = 1). Ultimately, 55 patients were included, and divided into block  and no-block  groups. Based on the order of the surgical schedule, the patients with an odd-numbered position in the surgical schedule were assigned to the block group, whereas those with an even-numbered position were assigned to the no block group. A flow diagram of patient recruitment is shown in RATT involves three stages. First, flap dissection creates a working space from the axilla to the thyroid gland; the flap is lifted via external retraction. The second stage involves docking (positioning of the robotic arms) and the final (console) stage involves operation of the system by the surgeon. In this study, all procedures were performed by a single surgeon (K.K.) using the da Vinci single-port robotic system. The details of flap dissection have been described elsewhere . The pecPropofol, rocuronium, and fentanyl were used to induce general anesthesia, and desflurane (in an air/oxygen mixture) and remifentanil were applied to maintain anesthesia. The monitoring modalities included electrocardiography, pulse oximetry, noninvasive blood pressure measurement, bispectral index assessment, and measurement of end-tidal carbon dioxide and esophageal temperature. At the end of surgery, a single dose (1 g) of acetaminophen  was injected into all patients for pre-emptive analgesia. The neuromuscular blockade was reversed by sugammadex under ventilation with 100% oxygen in the post-anesthesia care unit (PACU). In cases of moderate-to-severe postoperative pain , rescue analgesics were infused intravenously based on the discretion of the attending physicians: 50 μg of fentanyl in the PACU, and 25 mg of diclofenac  in the ward .w/v) was injected at the level of the third rib. The anesthetic spread around the axilla, and the needle was withdrawn to the point in the plane between the pectoralis major and minor muscles. A second injection of 20 mL ropivacaine (0.375% w/v) was then delivered (PECS II) [All pectoral nerve blocks were established by one highly experienced anesthesiologist (M.S.C.), and informed consent was obtained from each patient a day before surgery. After induction of general anesthesia with the patient supine, the left or right infraclavicular and axillary areas (depending on the dissection side) were cleaned with chlorhexidine, and an ultrasound probe was placed obliquely over the second and third ribs below the lateral one-third of the clavicle  ,15. UltrThe VAS pain scores were recorded at 4, 10, 20, 25, 35, and 45 h after surgery, and the rescue painkiller requirements in the PACU and ward were logged.We recorded patient age and gender, extent of the operation, pathology, and thyroid tumor features .p-value < 0.05 was considered statistically significant. All statistical analyses were performed with IBM SPSS Statistics for Windows .The normality of continuous variables was evaluated using the Shapiro–Wilk test. Continuous variables are reported as mean ± standard deviation and group differences were assessed using Student’s t-test or the Mann–Whitney U test. The paired t-test or Wilcoxon signed-rank test was used to compare VAS scores against those obtained at 4 h postoperatively. Categorical variables are reported as frequencies (percentages) and group differences were assessed using the Pearson chi-squared test or Fisher’s exact test. A two-sided The clinicopathological characteristics of the block and no-block groups are summarized in p = 0.628). The block group had significantly lower VAS scores at 10 and 25 h . However, no significant group difference was observed after 35 h. The block group experienced an early  reduction in pain but the no-block group reported a reduction only after postoperative day 1. In terms of painkiller usage, the block group required fewer rescue analgesics in the PACU than the no-block group, although the difference was not statistically significant in the ward.The main finding of this study was that PECS II may be a valuable analgesic option for reducing flap dissection pain and stress, as well as opioid consumption during early recovery after RATT. PECS II may provide early pain relief; patients who received this block recovered more comfortably and require fewer painkillers.RATT is an emerging, safe, and feasible technique providing outcomes comparable to, or better than, those of conventional open or endoscopic surgeries . HoweverCurrent pain control strategies are based on multimodal approaches, such as the enhanced recovery after surgery (ERAS) protocol; regional analgesic blocks are the cornerstones of such regimens . During We found that PECS II can provide sufficient analgesia during RATT flap dissection, possibly by blocking the lateral cutaneous branches of the intercostal nerves  via analgesia of the upper anterolateral chest wall. PECS II (which includes PECS I) was induced by a second injection lateral to the PECS I injection point  in the plane between the pectoralis minor and serratus anterior muscles. This blocked the upper intercostal nerves at the level of the third rib . During Although rare, potential complications of a PECS II include infection, thoracoacromial artery injury and hematoma, pneumothorax, iatrogenic intravascular injection, and local anesthetic toxicity . The latThis study had some limitations. First, as it was preliminary and retrospective, selection bias may have been present. Second, given the female predominance of thyroid disease in the general population , the effPECS II may serve as a new pain relief modality, and may be a valuable addition to the current multimodal analgesic strategy for patients undergoing RATT. Although we have yet to investigate the optimal block duration and technique, regions of sensory loss, or possible complications, our preliminary study suggests that this new pain management technique reduces flap dissection pain and thus aids recovery. Appropriate analgesia during RATT remains challenging, but is key for postoperative recovery. We are prospectively validating the pain results to establish a pain control regimen for patients undergoing RATT.


This study was performed to quantify the morphological characteristics of the psoas major muscle in patients with symptomatic multilevel degenerative lumbar spinal stenosis (SMLSS) and assess the correlations of these morphological characteristics with function and clinical symptoms.One hundred fourteen patients diagnosed with SMLSS (≥ 3 segments) were included. The patients’ presenting symptoms were assessed with the Oswestry Disability Index (ODI), and visual analogue scale (VAS) scores were recorded. The morphology of the psoas major was evaluated at the L3/4 intervertebral disc level in three ways: by measuring (i) the psoas muscle mass index (PMI); (ii) the mean muscle attenuation ; and (iii) the morphologic change of the psoas major .p = 0.001). Patients with severe disability had a significantly lower PMI (p = 0.002) and muscle attenuation (p = 0.001). The PMI and muscle attenuation were significantly higher in the patients with no or mild back pain (both p < 0.001). In the univariable and multivariable analyses, a greater HU value was associated with a higher functional status as assessed by the ODI (p = 0.002), and a higher PMI was associated with less severe back pain as measured by the VAS score (p < 0.001).Men had a higher PMI than women (This study showed that muscle attenuation of psoas major positively correlated with the functional status and PMI negatively correlated with low back pain severity in patients diagnosed with SMLSS. Future prospective studies are needed to evaluate whether improvement in such muscle parameters through physiotherapy programs can alleviate the clinical symptoms and improve the functional status of patients with SMLSS. Degenerative lumbar spinal stenosis (LSS) is a narrowing of the spinal canal that results from loss of height of the intervertebral disc, hypertrophy of the facet joints, and thickening of the ligamentum flavum that compromises the neural structures at one or several levels of the lumbar spine . LSS is The psoas major has been considered to play a critical role in maintaining the physiological functions of the lumbar spine . In patiThe primary purpose of the present study was to investigate the association of the psoas major muscle size, density, and shape with the functional status and visual analogue scale (VAS) scores for the back and lower extremities in patients with SMLSS. We hypothesized that higher psoas major muscle CSA , muscle density (represented by muscle attenuation on CT images) and morphologic change of the psoas muscle (MPM) would be associated with less pain severity and higher functional status in patients with SMLSS.The records of patients who were admitted to our hospital because of SMLSS (≥ 3 segments) from January 2019 to December 2020 were screened for study eligibility. The diagnostic criteria for SMLSS were the presence of intermittent claudication, back and/or leg pain, and imaging features of multilevel LSS on lumbar magnetic resonance imaging (MRI) or computed tomography (CT). We excluded patients with spinal deformity , patients without available preoperative CT or MRI examinations within 2 years of surgery, patients with a history of lumbar surgery, and patients with cachexia due to infectious diseases, cancer, myopathies, or dyskinesia. This study was approved by the institutional review board following the declaration of Helsinki principles at our hospital (No. 2018014). As a retrospective study and the data analysis were performed anonymously.One hundred fourteen consecutive patients were selected, and the following basic data were collected for analysis: age, sex, body mass index (BMI), comorbidities, number of vertebral levels involved, and symptom duration. Functional performance was evaluated using the Oswestry Disability Index (ODI) score, and back and leg pain severity was evaluated using VAS scores.2/m2)  was used to quantify skeletal muscles within predefined validated boundaries of − 29 to + 150 Hounsfield units (HU) to exclude vasculature, bony structures, and areas of intramuscular fatty infiltration. The total CSA of the psoas major was determined in semiautomated fashion with manual tracing of the bilateral psoas major borders. The psoas major muscle mass index (PMI) was calculated by normalizing the CSA for height  was used for statistical analysis. Measurement data are described as mean ± standard deviation. Categorical data are described as frequency (percentage). Continuous data were tested for normality. If the data were normally distributed and the variances between the two groups were equal, the two-sided Student’s t-test was applied to evaluate differences between groups; otherwise, the nonparametric Wilcoxon rank-sum test was considered. For ordered categorical data, the nonparametric Wilcoxon rank-sum test was used. For the factors that may affect the ODI, VAS score, and muscle parameters, univariate linear regression was performed, and the factors with a In total, 114 patients were identified and entered into the database. The study group comprised 41 men and 73 women with a mean age of 69.9 ± 9.7 years. Major comorbidities were hypertension (63.2%), diabetes (30.7%), and cardiovascular disease (17.5%). A total of 12.3% of patients had a history of spinal disease other than lumbar disease. The duration of lower extremity pain ranged from 3 to 240 months, with a mean of 36.9 ± 55.9 months; back pain had been present for much longer .In the functional status and pain severity assessment, the mean ODI score was 54% ± 14%, the mean VAS score for back pain was 4.5 ± 2.4, and the mean VAS score for leg pain was 4.4 ± 2.8. Table p < 0.001). There was no significant difference in the HU value or MPM between men and women.Table The reliability of morphological measurements of the psoas muscle used in this study was determined to be excellent. The inter-rater reliability coefficients were high (≥ 0.93).The patients were divided into different groups according to their ODI scores   and VAS p = 0.002) and HU value (p = 0.001) than patients with moderate disability. The duration of back pain was longer in patients with severe disability (p = 0.037). No significant differences in age, sex, BMI, leg pain duration, number of levels involved, or MPM were found between the two performance groups.Patients with severe disability had a significantly lower PMI (p < 0.001). The back pain duration was longer in patients with moderate or severe pain (p = 0.004).The PMI and HU value were significantly higher in the patients with no or mild back pain than in those with moderate or severe back pain (both No significant differences in the patient characteristics or muscle parameters were found between different leg pain severity groups. Table p < 0.001) and HU value (p < 0.001). These muscle parameters and sex were entered into the multivariable regression models. The results show that muscle attenuation could negatively influence function (p = 0.002) and explained 30.4% of the variance in the ODI score.Age, BMI, symptom duration, and number of levels involved were not associated with function as measured with the ODI in the univariate analyses Table . Patientp < 0.001) and HU (p < 0.001) in the univariate analyses (Table p < 0.001). The PMI explained 40.8% of the variance in the VAS score for back pain.Patients with more severe back pain as assessed by the VAS score had a lower PMI . Similar outcomes were founded in this study. We revealed that a higher PMI was associated with less severe back pain in univariable and multivariable analyses and with better functional status in univariable analyses. The possible reason is that all patients in this study had multilevel spinal stenosis, which is usually combined with extensive lumbar degeneration such as facet arthropathy and spondylosis . These d2 circle)] in patients with LSS was higher than that in the control group; however, the author did not examine the relationship between the muscle density and functional status. Our results showed that although there was no obvious fat deposition in the psoas, there was still great variation in muscle density as assessed by the HU. The attenuation values of muscle on CT can provide quantitative data regarding the composition of muscle [The psoas major muscle rarely undergoes fatty degeneration; therefore, few studies have evaluated the correlation between the psoas muscle density and lumbar degenerative diseases. Abbas et al.  discoverf muscle . The attf muscle . The ODIf muscle , and aftf muscle . Our resf muscle , 26.The MPM can reflect muscle atrophy and may serve as a predictor of complications after colorectal cancer surgery . There wThere was also no correlation between the psoas major morphology characteristics and the VAS score for the lower extremities, indicating that the symptoms of the lower extremities in patients with SMLSS were caused by compression of lumbar nerve roots rather than paraspinal muscle degeneration .Our study has several limitations. Firstly, because of its retrospective design, we were unable to control for accuracy in the documentation of medical treatment of low back pain or lower extremity pain before hospitalization, which may have affected the functional scores. Secondly, the muscle measurements were only obtained at the L3/4 intervertebral disc level using a single slice. Multiple-slice analysis and volumetric data may provide a more accurate muscle morphology assessment. Thirdly, the paraspinal muscles  coordinate with each other to maintain the lumbar spine's movements and stability. This study only evaluated the relationship between the morphology of psoas major and the functional status and symptoms. In the future, it is necessary to comprehensively evaluate the clinical effect of morphology and strength of paraspinal muscles. Finally, this study had a relatively small sample size and was conducted at a single center. Further prospective multicenter studies are needed to confirm our findings.This study suggests that the muscle attenuation and PMI of the psoas major are closely related to the functional status and severity of back pain in patients with SMLSS. Considering the high perioperative risk of surgical treatment for SMLSS, development of safe and effective conservative treatment is of great clinical significance. Therefore, whether improvement in the quality and quantity of the psoas major muscle through exercise can alleviate the clinical symptoms and improve the functional status of patients with SMLSS should be examined in future studies.


Intravenous patient-controlled analgesia (IV-PCA) is often used in the postoperative period. However, determining an appropriate opioid dose is difficult. A previous study suggested the usefulness of variable-rate feedback infusion. In this study, we used a dual-channel elastomeric infusion pump to provide changes in PCA infusion rate by pain feedback.Ninety patients undergoing orthopedic surgery of American Society of Anesthesiologists grade I-III and 65 to 79 years of age participated in the study. All patients were given a dual-chamber PCA. Patients were randomly allocated to a treatment group  or control group . The primary outcome was the amount of fentanyl consumption via PCA bolus. The secondary outcome variables were pain score, total fentanyl consumption, rescue analgesic use, patient satisfaction, recovery scores, and adverse events including postoperative nausea and vomiting (PONV).Group D showed decreased fentanyl consumption of the PCA bolus, a decrease in rescue analgesic use, and better patient satisfaction compared with group C. The incidence of PONV was much higher in group C. There was no difference in other adverse events.We showed the usefulness of dual chamber IV-PCA to change the flow rate related to pain feedback without any complications. Our results suggest a noble system that might improve existing IV-PCA equipment.UMIN000039702).The study registered at UMIN clinical trial registry (registered date: 05/03/2020, registration number: The online version contains supplementary material available at 10.1186/s12871-022-01733-2. Bolus injection and continuous infusion are two methods of intravenous (IV) drug administration. As many clinicians know, both methods have limitations from the viewpoint of pharmacokinetics. If the target opioid plasma concentration is provided, a sufficient bolus dose shows an exponential decay with a transiently higher plasma concentration, followed by a concentration lower than the target level . TherefoAmong numerous pain control methods, opioid-based intravenous patient-controlled analgesia (IV-PCA) is commonly used to relieve postoperative pain , 3. IV-PMany PCA devices have been developed and used since the 1960s . InitialThe Bellomic®M  is a newly designed IV-PCA device that consists of a dual infusion elastomeric pump with two balloon chambers. One channel contains a continuous flow-rate chamber and has a bolus function, whereas the other channel contains an adjustable flow-rate chamber without a bolus function.The purpose of this study was to use this dual channel elastomeric IV-PCA for elderly patients undergoing orthopaedic surgery and evaluate the efficacy of dual-channel IV-PCA compared to single-channel IV-PCA and single placebo channel via PCA opioid consumption, postoperative pain, rescue analgesic, subjective satisfaction of the patient, and other adverse events. We hypothesized that more efficient pain management would be achieved if the flow rates were adjusted according to patient pain feedback using this dual-channel IV-PCA device.This study was a single-centre prospective randomized controlled trial conducted from 2019 to 2020. We followed the Consolidated Standards of Reporting Trials (CONSORT) guidelines when designing this study. After receiving approval from the institutional review board, it was registered at the UMIN clinical trial registry .Elderly patients 65–79 years of age, of American Society of Anesthesiologists (ASA) class I-III, undergoing orthopaedic surgery, excluding patients with a body mass index (BMI) > 35, drug abuse or dependence, history of drug allergy , cognitive disorder, dementia, other psychiatric disease, speech impairment, and severe chronic pain other than at the surgical site, were included. Written informed consents were obtained from all the subjects. Demographic data including age, sex, weight, height, ASA class, and underlying diseases including hypertension, diabetes mellitus, and cerebrovascular accident were collected from all the patients.www.randomization.com). The subject numbers, which were kept in opaque sealed envelopes, were checked only by an independent anaesthesiologist who did not have a role other than making PCA in the operating room. The patients and other clinical investigators were blinded to the group allocation.All patients received a dual-chamber PCA just after arriving in the post-anaesthesia care unit (PACU). Patients were randomly allocated to a treatment group  or control group , and they were unaware of the group assignment. One independent investigator was responsible for the generation of the random allocation sequence and the group assignment of patients. Randomization was done in two blocks using a web-based computer-generated list  reported in a previous study [The Bellomic®M  is a dual channel infusion elastomeric pump. The basal-bolus channel provides a 2 mL/h fixed flow rate infusion and a bolus function . The other selector channel can be set to 0, 1, or 2 ml/h with an adjustable flow rate without a bolus function. The maximum volume of each chamber is 100 ml.In group D, the IV-PCA contained fentanyl 13.3 μg/kg + ramosetron 0.4 mg with normal saline to a total volume of 100 ml in the basal-bolus channel with a constant rate of 2 ml/h and fentanyl 6.7 μg/kg + ramosetron 0.2 mg with normal saline to a total volume of 50 ml in the selector channel with adjustable rates of 0–2 ml/h. In group C, IV-PCA contained fentanyl 20 μg/kg + ramosetron 0.6 mg with normal saline to a total volume of 100 ml in the basal-bolus channel with a constant rate of 2 ml/h and 50 ml of normal saline in the selector channel with adjustable rates of 0–2 ml/h. In both groups, the initial rate of the selector channel was 1. When the pain score  was 7 or more in the PACU and 5 or more in the ward, the flow rate of the selector channel was increased by 1 (maximum 2), and when the pain score was 3 or less, the rate was decreased by 1 (minimum 0) (see the perioperative management in the method section). When the flow rate was fixed at 1 without adjustment, except for an additional bolus dose, the amount and infusion rate of fentanyl used in group D and group C became the same. A schematic of the IV-PCA regimen is shown in Fig. 2 of 0.5, and 3 l/min of fresh gas flow rate during surgery. Initial settings of tidal volume were 8 ml/kg, I:E of 1:2, and airway pressure that was adjusted to not exceed 25 cmH2O. At the end of surgery, all anaesthetics were stopped, and ventilator settings were changed to FiO2 1.0 and 8 l/min of fresh gas flow rate. Then, 2 mg/kg of sugammadex was administered. Return of neuromuscular function was confirmed using TOF peripheral nerve stimulation. Before extubation, four equal twitches in the TOF were required. Extubation was performed when a patient was awake .All patients were monitored by pulse oximetry, electrocardiography, automatic noninvasive blood pressure measurement, bispectral index (BIS), capnography, end-tidal concentration of volatile anaesthetics, and train-of-four (TOF). Blood pressure was monitored at 5-min intervals and the heart rate was monitored continuously. After preoxygenation, anaesthesia was induced with an intravenous 2 mg/kg of propofol bolus by rocuronium 0.6 mg/kg. After loss of consciousness, tracheal intubation was performed. Patients received 0.6–2 vol% of sevoflurane with remifentanil infusion for the maintenance of anaesthesia. The depth of anaesthesia was adjusted during surgery to maintain BIS values of 40 to 60 and mean blood pressures at 80 to 120% of the baseline value. Minute ventilations were adjusted to maintain normocapnia with an FiO2 < 95%) were recorded. Then, 0.075 mg of palonosetron was administered to patients with PONV. If there was no abnormality, the patients stayed in the recovery room for 60 min and were then moved to the ward.IV-PCA was initiated just after arrival to the PACU. A simple mask with an oxygen flow rate of 5 l/min was applied to patients in the PACU. The pain score, level of consciousness, and modified Aldrete post-anaesthesia recovery score (PARS) were evaluated every 5 min. The pain score was evaluated using the VAS with a range from 0–10 points. When the pain score was 7 or more, the flow rate of the selector channel was increased by 1 (maximum 2) and fentanyl 1 μg/kg was intravenously administered as a rescue analgesic. Rescue analgesic can be administered up to two times  in the PACU. When the pain score was 3 or less, the flow rate of the selector channel was decreased by 1 (minimum 0). The Richmond Agitation and Sedation Scale (RASS) and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) were used to determine the level of consciousness and assess delirium. Any adverse events including postoperative nausea/vomiting (PONV), dizziness, dry mouth, episode of bronchospasm, laryngospasm, or oxygen desaturation . When the pain score was 5 or higher in the ward, the flow rate of the selector channel was increased by 1 (maximum 2), and intravenous nefopam 20 mg was administered as a rescue analgesic over 15 min.U-test where appropriate. Data expressed as the number of patients were compared using chi-square analysis when any cells with expected values below 5 did not exceed 20% in the contingency table or Fisher’s exact test where appropriate. Repeated measures analyses of variance (RM-ANOVA) were applied for repeated measured variables including fentanyl consumption in PCA and pain score for the analysis of group effects. We adopted the results of tests showing a within-subject effect when the sphericity condition of data was satisfied or the results from multivariate analyses.After confirming normality by the Kolmogorov–Smirnov test, data expressed as the mean ± SD were compared between the two groups using independent t-tests or the Mann–Whitney P-values below 0.05 were considered statistically significant.Statistical analyses were performed using the Statistical Package for Social Sciences, version 22.0. A total of 87 patients were enrolled in this study excluding 3 patients who withdrew consent (43 patients for group D and 44 patients for group C). There was no significant difference in the demographic data between the two groups Table . Total ap < 0.001). However, multivariate analysis did not reveal any significant differences in the changes of pain intensity or infusion rate of selector channel between the two groups    Fig. , Table 3The amounts of fentanyl administered as bolus at postoperative 1–6, 6–12, and 12–24 h were much lower in group D compared to group C Fig. . Patientp = 0.049), but not in group C (18.2% on operation day to 18.2% at postoperative day 2). There were no significant differences for other complications  may help to establish a strategy for pain management. MEAC explains the phenomenon that pain decreases dramatically at a specific point as a result of administering the drug in small increments . Conside3 receptor blockers were independent risk factors for rescue antiemetic administration. A higher background infusion rate may increase daily opioid consumption, and consequently may increase the incidence of adverse effects. However, a higher background infusion rate did not always lead to better pain relief and improved sleep patterns [The next step was to select the drugs and dose for IV-PCA. We examined previous studies to determine the ideal IV-PCA regimen , 14. In patterns . Shin etLee et al.  applied We also assumed that as the pain intensity steeply decreased, adverse effects including PONV and dizziness might become troublesome. To reduce PONV, we mixed ramosetron in the PCA and used prn palonosetron in the PACU after considering their pharmacokinetic properties . Our resIt is natural that efficient pain control and a lack of side-effects induce higher patient satisfaction. Chumbley et al.  identifiWe also focused on the occurrence of delirium because old age and inadequate pain control are known factors of delirium . Eight cThere were other limitations. We did not consider adjuvant analgesics in the PCA although we usually use a combination of fentanyl, hydromorphone, ketorolac, or nefopam. When we designed this study, we chose the simplest regimen to avoid ambiguous interpretation. However, to fully utilize our dual channel, it is likely that additional experiments with a combination of several drugs will be required. That is, this study alone was not enough to demonstrate the full potential of the dual channel PCA pump. In addition, because we simply targeted the pain score as feedback, there was no discrimination between opioid tolerance or opioid-induced hyperalgesia. In this case, it might have been better to use another analgesic instead of opioids. We used nefopam as a rescue medication in the ward. A previous study  reportedNevertheless, this study demonstrated the successful application of a new developmental form of IV-PCA. Considering few studies have used a dual chamber PCA, our regimen might help clinicians apply a similar type of PCA. With considering the simplicity of use and fewer incidence of device related-errors  of elastIn conclusion, this study demonstrated the clinical application of a new form of IV-PCA for geriatrics. Dual chamber IV-PCA by changing the flow rate to pain feedback provided efficient analgesia, with reduced PONV, and high patient satisfaction without severe complications.Additional file 1. Consort diagram.Additional file 2. Specific information of the PCA device usedin the study. It contains the design, shape, function, and dimension ofdetailed components of the device.


Lumbar disc herniation (LDH) is a common and frequently occurring disease in clinics. Low back pain and sciatica are the presenting symptoms of LDH. To some extent, it can be considered that measures with the capability to improve low back pain or sciatica have the potential to treat LDH. Ma’s bamboo-based medicinal moxibustion therapy can effectively reduce the degree of low back pain and has been widely used. Studies of small sample size have seen significant improvement on pain relief. The aim of this trial is to evaluate the clinical efficacy and safety of Ma’s bamboo-based medicinal moxibustion therapy in the treatment of LDH low back pain.n=156) and an acupuncture group (n=156). Patients in each group will receive treatment every day, 6 times a week, 12 times in total. Follow-up will be conducted 14 days after treatment. The primary outcome will be the visual analog scale(VAS) at baseline, after 6 times of treatment, end of treatment, and follow-up. The secondary outcomes will include Oswestry disability indexes (ODI), modified Japanese Orthopaedic Association low back pain (M-JOA) score, serum β-endorphin (β-EP), and serum substance P (SP). β-EP and SP, as well as safety evaluation indexes , will be measure at baseline and after the end of treatment. The number, nature, and severity of adverse events will be recorded.The trial is a multicenter, randomized, parallel-group, non-inferiority study. Three hundred and twelve patients will be randomly assigned to a Ma’s bamboo-based medicinal moxibustion group (The results of the trial will compare the efficacy of low back pain in LDH between Ma’s bamboo-based medicinal moxibustion group and the acupuncture group and will be expected to make a systematic and objective evaluation of the clinical efficacy and safety of Ma’s bamboo-based medicinal moxibustion therapy.ChiCTR2000038725. Registered on 29 September 2020.The online version contains supplementary material available at 10.1186/s13063-022-06382-x. Lumbar disc herniation (LDH) is a syndrome caused by the compression and stimulation of the lumbosacral nerve root and cauda equina nerve owing to the degeneration of the lumbar intervertebral disc, rupture of annulus fibrosus, and resulted nucleus pulposus protrusion. It occurs frequently in young and middle-aged individuals, with a higher incidence in males than females, among which L4/5 and L5/S1 are the vulnerable sites (>90%) . ClinicaLow back pain and sciatica are the presenting symptoms of LDH. To some extent, it can be considered that measures with the capability to improve low back pain or sciatica have the potential to treat LDH . In relaChina, India, Brazil, and other countries have rich traditional medicine resources , 12, butIn our previous research, 14 LDH patients with low back pain were treated with Ma’s bamboo-based medicinal moxibustion. The clinical pre-trial found that 2 cases were clinically cured, 4 cases were markedly effective and 6 cases were improved. Besides, the post-treatment VAS score, ODI score, and M-JOA score were significantly lower than those before treatment (P<0.05). It suggests that this therapy has a certain application value clinically, which, however, lacks evidence-based evaluation. There is an absence of high-level clinical efficacy data, which restricts the real participation of the therapy in clinical decision-making and, hence, hinders its clinical popularization and application to a great extent.Folk medicine resources are not only the medical characteristics of a country, but also the embodiment of a country’s cultural and economic characteristics. They are the unique areas of independent innovation of a country and a nation’s medicine. It is essential to actively explore and sort out folk medicine resources to protect their own and national medicine culture.Thus, we designed this multi-center, randomized controlled trials to evaluate the clinical efficacy and safety of Ma’s bamboo-based medicinal moxibustion therapy in the treatment of LDH low back pain, in order to obtain evidence-based evidence that can be replicated and has high evidence level and to provide clinicians and patients with an appropriate technology that has evidence-based support for clinical efficacy and safety. At the same time, this study will be connected with China’s national intellectual property protection platform, and provide a reference for the establishment of an effective system of mining, sorting, screening, and evaluation of folk traditional Chinese medicine characteristic diagnosis and treatment technology at the national level, so as to promote the sustainable development and popularization and application of folk traditional Chinese medicine characteristic technology, constantly enrich the diagnosis and treatment technology and means of traditional Chinese medicine promote the development of the pharmaceutical industry and benefit the people.The objective of this randomized controlled trial is to evaluate the efficacy and safety of Ma’s bamboo-based medicinal moxibustion therapy in the treatment of patients with LDH low back pain. The specific objectives are (1) to evaluate the effectiveness of Ma’s bamboo-based medicinal moxibustion therapy in improving pain, lumbar dysfunction, daily living ability, and regulating of serum β-endorphin (β-EP) and serum substance P (SP) content in patients with LDH low back pain and (2) to evaluate the safety of this therapy by recording blood routine, liver and kidney function, electrocardiogram results, and the number, nature, and severity of adverse events.This is a parallel, non-inferiority, randomized controlled clinical trial aiming to compare the effect of Ma’s bamboo-based medicinal moxibustion therapy and regular acupuncture therapy on low back pain in LDH patients. The patients will be enrolled among outpatients and inpatients from the acupuncture departments of No.1 Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, No.2 Affiliated Hospital of Guizhou University of Traditional Chinese medicine. Eligible patients will be randomly assigned to a Ma’s bamboo-based medicinal moxibustion therapy group and an acupuncture group in a 1:1 ratio. All items from the World Health Organization Trial Registration Data Set are shown in Table The protocol has been approved by the ethical committee of No. 1 Affiliated Hospital of Guizhou University of Traditional Chinese Medicine , and the study is registered at the Chinese Clinical Trial Registry, ChiCTR .Participants and the public were not involved in the design or recruitment of this clinical trial. We will invite patients to be involved in the development of dissemination strategies.Lower limb radiative pain, of which the pain location was consistent with the corresponding affected innervation areaLower limb sensory abnormalities, with decreased superficial sensation of the skin in the corresponding affected innervated areaPositive result of Lasegue test, Bragard test, Lasegue test of the unaffected side, or femoral nerve stretching testWeaker tendon reflex than that of the unaffected sideMuscle weaknessIntervertebral disc herniation indicated by lumbar MRI or CT, of which the nerve compression was consistent with the symptoms, signs of the affected nervesIn the first five criteria, patients could be diagnosed as LDH when meeting three of them combined with item 6The diagnostic criteria  are:LoweIntervertebral disc bulging, with an outward bulge of the annulus fibrosus of the whole intervertebral disc uniformlyLocalized herniation of the intervertebral disc, rupture of the inner layer of annulus fibrosus of the intervertebral disc, and partial herniation of nucleus pulposusIntervertebral disc herniation, rupture of most annulus fibrosus of the intervertebral disc, with intact outer annulus fibrosus merely, and the nucleus pulposus confined to the intervertebral discProlapse of the intervertebral disc, rupture of all annulus fibrosus of the intervertebral disc, nucleus pulposus tissue protruding out of the intervertebral disc and bound by the posterior longitudinal ligamentSequestered disc herniation, nucleus pulposus tissue protruding out of the annulus fibrosus and posterior longitudinal ligament, and sequestered in the spinal canalNote: In this trial, patients with a pathological classification of intervertebral disc bulging, localized herniation of the intervertebral disc, and intervertebral disc herniation will be selected for experiment according to the long-term treatment experience and practice by using Ma’s bamboo-based medicinal moxibustion therapy.Low back pain due to cold-dampness evil2.Low back pain due to dampness-heat evilThe presence of a history of suffering from cold in the waist, aggravation of symptoms when the weather changes or when there is cloudy, rainy, or cold weather, with severe cold and pain in the waist, accompanied by numbness or contracture that restricts the body movements of bending or raising up, even with pain involving the lower limbs3.Low back pain due to static bloodSevere and heat pain in the waist, aggravation of symptoms in summer-heat and damp, cloudy and rainy weather, and possible alleviation after activities, accompanied by heavy body and feeling of sleepy, short voiding of reddish urine, yellow and greasy fur on the tongue, as well as soft and frequent pulse or wire and frequent pulse4.Low back pain due to kidney deficiencyThe presence of a history of strain or old injury in the waist, aggravation of symptoms when getting up in the morning, tired and sitting for a long while, with stiffness of the muscles on both sides of the waist, pain like the stabbing of a needle, and pain in a fixed siteMajor manifestations of soreness and weakness, with dull pain, alleviation when pressing and lifting, accompanied by weakness in legs and knees with relief when lying down and repeated onset, with fatigue and hypersomnia, and thready pulse as wellNote: In our study, patients with all the types based on the syndrome classification mentioned above will be included for experiment according to the long-term treatment experience and practice by using Ma’s bamboo-based medicinal moxibustion therapy.Patients who meet the above diagnostic criteria and pathological classification, with the lesion located in L3–S1Patients aged 18–65 years, males or femalesPatients with the course of disease ≥6 monthsDrug users with drug withdrawal for 4 weeks, and non-drug users with discontinued treatment for 2 weeksPatients with 3 ≤ VAS scores ≤6Willingness to sign written informed consentPatients who meet all of the following criteria will be enrolled in the trial:Patients with acute onset of low back pain in lumbar disc herniationPatients with low back pain caused by other causesPatients with other diseases requiring combined treatment using anti-inflammatory and analgesic drugsPatients during pregnancy, lactation, or pregnancy preparationPatients with rash, skin damage, ulcers, or other infectious diseases at the waistPatients with serious diseases of the heart, liver, kidney, blood system, etc.Patients with mental disorders or communication disorders who could not cooperatePatients with high fever and Yin deficiencyPatients who meet any of the following criteria will be excluded from the trial:Occurrence of severe adverse eventsOther treatments received that could affect the outcomeVoluntary withdrawal for any reasonPatients who meet any of the following criteria will be withdrawn:The PASS software version 15.0  was used to estimate the sample size. The trial is designed to determine the efficacy of Ma’s bamboo-based medicinal moxibustion therapy on low back pain in LDH and prove that its clinical efficacy is not inferior to normal acupuncture therapy. Therefore, we chose a non-inferiority trial design. According to the previous literature , 18 and Central randomization will be conducted by INTELLIGENCE FUTURE Soft Co., Ltd. . A random sequence will be generated with SAS 9.2  by an independent statistician who is not involved in the study, and the sequence will be stored in a central randomization system (interactive web response (IWR) system). Allocation will adopt a stratified random method. Stratified block randomization will be carried out by third party statisticians who will be not involved in any other part of the trial. The patients will be stratified based on the two different centers and randomly assigned to the Ma’s bamboo-based medicinal moxibustion group and the acupuncture group in a 1:1 ratio. The Ma’s bamboo-based medicinal moxibustion group will receive Ma’s bamboo-based medicinal moxibustion therapy. Regular acupuncture therapy will be performed on the acupuncture group. There are two investigators at each center (referred to as A and B). Investigator A will log in to the central randomization system on the computer and be responsible for inputting baseline data of patients, waiting for the system to assign random numbers and grouping, but he will not know the details of grouping and will not participate in treatment. Investigator B is responsible for performing treatment according to the grouping. Due to the nature of the intervention, it is not feasible to conceal the assignment from Investigator B and the patient, but Investigator B will not be permitted to disclose any information about his treatment to Investigator A or the patient. At each visit, A is responsible for collecting data and entering the data in the electronic data capture (EDC) system. The therapist and the data collector are separate. Statisticians are responsible for data processing and are not aware of the grouping until the end of the trial.In this trial, patients and therapists will not be blinded due to the uniqueness of the two therapies. Investigators and statisticians will be blinded. Treatment, data collection, and data analysis will be conducted by trained practitioners, data collectors, and statisticians, respectively, all blinded to one another in order to ensure the reliability of the results.The conditions for unblinding are (1) infection or other adverse events, and these patients will be withdrawn from the trial or (2) the end of the trial and data analysis.All treatments will conduct in the outpatient treatment rooms of the two centers. The therapists will not be involved in the other parts of the trial. The treatments will be performed every day, for a total of 12 treatments. All the treatments will be completed within 13 days. The assessments of the treatments will be performed after treatment, on the 7th day, the 14th day, and the 28th day. All practitioners involved in the trial are trained and registered professionals. Acupuncture was performed by primary physicians with >5 years of experience at each center. A training program to standardize all manipulations and filling of a case report form (CRF) will be provided before the trial. Investigators will inform all patients about the possible inconveniences of the trial.Clematidis Radix Et Rhizoma), Du Huo ( Angelicae Pubescentis Radix), Rou Gui (Cinnamomi Cortex), Xi Xin (Asari Radix Et Rhizoma), Chuan Xiong (Chuanxiong Rhizoma), Sang Ji Sheng (Taxilli Herba), and Gui Zhi (Cinnamomi Ramulus) (250g each) will be mixed and powdered through a 300-mesh sieve and stored in a dark box for later use. (2) Preparation of medicinal wine of Ma’s bamboo-based medicinal moxibustion: Wei Ling Xian (Clematidis Radix Et Rhizoma), Ji Xue Ten (Spatholobi Caulis), Chuan Niu Xi (Cyathulae Radix), Xi Xin (Asari Radix Et Rhizoma), Du Huo (Angelicae Pubescentis Radix), Chuan Xiong (Chuanxiong Rhizoma), Sang Ji Sheng (Taxilli Herba), and Rou Gui (Cinnamomi Cortex) (200g each) will be placed in 21,000 mL liquor and spirits of 50° for 7 days for subsequent use. (3) Preparation of medicinal moxibustion tool: bamboo tube with an inner diameter of 5cm is taken with the stem nodes removed, and cut with a hacksaw according to the specification of 5×4cm (inner diameter × height). Then, with the removal of the bamboo bark on the surface, the edge of the bamboo tube is polished smooth and round to prepare a unique medicinal moxibustion tool. (4) Preparation of moxa cone: 3 g of moxa  are made into several moxa-cone with moderate hardness (2.5 cm in height and 2 cm in diameter) for reserve. (5) Operation: 15g of medicinal powder and 20 ml of medicinal wine are mixed evenly, and the finished product is then placed into the medicinal moxibustion tool to press into the medicinal cake. Moxa cone will be placed on the compressed powder and ignited for preheating. The patients are informed to take the prone position with the moxibustion sites exposed. L1-L5Jia ji (EX-B2), Shenshu (BL23), Mingmen Point (GV4), and Yaoyangguan (GV3) are selected for moxibustion. The acupoint positioning is performed in accordance with the nomenclature and location of acupuncture points (GB/T 12346-2006), [The specific operations of Ma’s bamboo-based medicinal moxibustion group are as follows: (1) Preparation powder of Ma’s bamboo-based medicinal moxibustion: Wei Ling Xian (6-2006), . The thethe Evidence-Based Guidelines of Clinical Practice with Acupuncture and Moxibustion Low Back Pain [The selection of acupoints for the acupuncture group will follow according to the major acupuncture point prescription in ack Pain , with poack Pain . Each paack Pain , 22. AftDuring the whole period of observation, it is suggested that the patients do not use drugs or other methods for the treatment of low back pain in LDH in addition to the experimental scheme. During the treatment period, if the patients take medication by themselves or use other methods of treatment due to aggravated symptoms and unbearable lumbar pain, they will be withdrawn from the trial. The clinicians will make the appropriate treatments according to the specific conditions of the patient until the symptoms are improved.We will use the visual analog scale as the primary outcome measure . VAS is Oswestry disability index (ODI) , 25 is oModified Japanese Orthopaedic Association low back pain (M-JOA) score  is a freg for 20 min, the supernatant was then collected and stored in a refrigerator at − 80°C for further measurement. Enzyme-linked immunosorbent assay (ELISA) was used for determination, and the operation was carried out in strict accordance with the instructions of the kit. The test is conducted by the Central Laboratory of No.1 Affiliated Hospital of Guizhou University of Traditional Chinese Medicine.Serum β-EP and serum SP will be used to assess the improvement of pain in LDH. Previous clinical studies , 28 haveFrom the time of participation in this study to the end of follow-up, it is recommended that patients do not take anti-inflammatory and analgesic drugs or any other non-drug therapy for low back pain, because this may affect the objective evaluation of the efficacy of Ma’s bamboo-based medicinal moxibustion therapy. However, if the patient needs to use other treatment methods other than the treatment plan of this study, patients can apply to the investigator to withdraw from the clinical trial, and any rights and interests of the patient will not be harmed.Before the start of the trial, the investigators will fully inform the patients of the benefits and the possible inconvenience of the study. MRI of the lumbar vertebrae, laboratory examination, and twelve times of treatment will be free of charge in order to improve the adherence of the patients. The baseline data of each patient  will be recorded in detail, hereby to facilitate the supervision of patients’ adherence. The cases of drop-out, withdrawal, and discontinuation will be recorded and followed up by telephone or even followed up at patients’ homes if necessary.Our study group will set up a special data monitoring committee for data management and quality control, which consists of hospitals, company, and institute.All three-level quality monitoring system was established. Clinical research associates (CRAs) were assigned for data monitoring. Level 1 monitoring requires the CRAs in the two hospitals  to monitor the quality of the CRFs once a week, fill out the monitoring report, and report to the principal investigator (PI) in time. Level 2 monitoring requires the CRA from INTELLIGENCE FUTURE Soft Co., Ltd to conduct quality monitoring once every six months, fill out the monitoring report, and report to the project leader of INTELLIGENCE FUTURE in time. Level 3 monitoring requires the person in charge or the technical backbone at the institute of Chinese Medical History and Literature, China Academy of Chinese Medical Sciences to monitor once or twice annually.The data management platform was set up by INTELLIGENCE FUTURE soft Co., Ltd. It includes the IWR and EDC systems. It includes nine modules, including data entry and statistics. All data will be entered using a double-entry procedure performed by two different individuals.The study clinician obtained written consent from the patient. All subjects included in the present clinical study had voluntarily participated, signed an informed consent form . The Wilcoxon rank-sum test, Possible adverse events during Ma’s bamboo-based medicinal moxibustion treatment include itching, scald, redness, blister, and infection. Fainting, sticking of needle, hematoma, subcutaneous hematoma, and bleeding might occur during acupuncture treatment. Therapists and subjects are informed to actively report any adverse events during the study. Researchers will track the results of safety evaluation indexes  before and after treatment in a timely manner, and confirm the occurrence of adverse events. Any adverse events that occur during the trial will be recorded in a CRF by researchers and patients will be treated as soon as possible. Patients may choose to withdraw from the trial due to any adverse events. The sponsor and the data management company INTELLIGENCE FUTURE will monitor the implementation of the trial protocol and filling of CRFs.The eligibility criteria, results, and analyses will not be modified once the first participant has been enrolled in the study. Any significant modifications to the protocol, such as study objectives, study design, eligibility criteria, sample size, results or analysis changes, will be approved by the Research Ethics Committee and the person in charge of the project leader and submitted to the relevant ethical review body.Data will be provided to the investigator responsible for the study. These results will be disseminated through presentations at academic and clinical conferences and will be published in peer-reviewed journals.Ma’s bamboo-based medicinal moxibustion therapy is a broad-spectrum folk therapy in china. On the basis of a modification of traditional herb-partitioned-moxibustion, it applies a unique moxibustion method and the ancestral formula for treatment, which shows an effect on treating chronic stubborn diseases such as LDH, chronic fatigue syndrome, cold due to body deficiency and other chronic stubborn diseases. In general, herb-partitioned-moxibustion can play a better role than routine moxibustion by using traditional Chinese medicinal formulae according to different individuals and diseases, which is thus widely used in clinical. It has been demonstrated that herbs-partitioned-moxibustion can alleviate low back pain in LDH , 30. HowClematidis Radix Et Rhizoma), Du Huo (Angelicae Pubescentis Radix), Sang Ji Sheng (Taxilli Herba), Xi Xin (Asari Radix Et Rhizoma), and Rou Gui (Cinnamomi Cortex). It is expected to exert the effects of dispelling wind and relieving pain, warming the interior and dispelling cold, activating blood circulation and removing blood stasis, and tonifying the liver and kidney. For the preparation of medicinal cake, different blending agents are selected according to different diseases in Ma’s bamboo-based medicinal moxibustion. For the treatment of low back pain in LDH, powder blending is performed with the application of the medicinal wine made of Ma’s traditional Chinese medicine prescription, which is useful for dispelling wind and removing dampness, promoting blood circulation, and relieving pain. It can hence stimulate skin tissue, expand capillaries, accelerate drug absorption and improve local blood circulation. Furthermore, on the basis of heat radiation to penetrate skin tissue through heat energy, moxibustion can play the role of anti-inflammation, analgesia, immune regulation, and blood circulation improvement [The synergistic effect of drugs, moxibustion, and acupoints constitutes the therapeutic mechanism of Ma’s bamboo-based medicinal moxibustion therapy. The pathogenesis of LDH shows association with the degenerative changes of the intervertebral disc, strain, trauma, pregnancy, etc. Low back pain is the primary clinical manifestation of LDH. In traditional Chinese medicine, the pathogenesis of the disease lies in wind-cold-dampness invasion, blood stasis, and kidney deficiency. It is the obstruction that causes the pain. Accordingly, the treatment should emphasize on promoting blood circulation, and dredging Qi and blood circulation. In terms of Ma’s bamboo-based medicinal moxibustion therapy for the treatment of low back pain in LDH, the traditional Chinese medicine prescriptions consist of Chinese herbal medicine in the folk selected by Ma’s family of traditional Chinese medicine in previous dynasties, which are used for external application and rubbing after processing, as well as the medication formula based on their medical practice experience for many years. According to the pathogenesis characteristics of “wind, cold, blood stasis and deficiency” of low back pain in LDH, the drug formula emphasizes on the use of drugs such as Wei Ling Xian (rovement . By the rovement .Ma’s bamboo-based medicinal moxibustion therapy is a characteristic external therapy of traditional Chinese medicine in the folk. It possesses many advantages, such as a wide range of suitable diseases, and small requirements for the operating environment. Moreover, it can be applied by hospitals, families, and individuals without special care. It can be used by the patients themselves after explanation and demonstrations by doctors, without relying on doctors with professional technology, which is easy to learn and popularize. Meanwhile, it can exert the curative effect through transdermal absorption of drugs directly on acupoints, avoiding the first-pass effect of oral drugs through the liver and possible gastrointestinal adverse reactions. It may be suitable for long-term continuous treatment of chronic diseases, which can contribute to alleviating the problems of “difficulty and high cost of getting medical service” in ethnic areas. It may be conducive to improve the service capacity of folk medicine and promote the healthy development of ethnic medicine. Besides, it may benefit the improvement of the health care level of the people and health service ability in grassroots.The trial has certain limitations. This protocol is an observational study of clinical efficacy, and most of the efficacy evaluation indexes are recorded by subjective scale. Besides, there is a lack of research based on imaging despite the detection of changes in laboratory indexes. In our subsequent research, we will continue to optimize the study design, and take into consideration of more objective indicators to conduct a more comprehensive study on the mechanism of the proposed therapy in LDH to further verify the curative effect.The trial is currently recruiting patients and is expected to end in December 2021. The first patient was enrolled in November 2020.Additional file 1. SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents.Additional file 2. Consent form.