Chronic pain inflicts damage in multiple spheres of patient's life and remains a challenge for health care providers. Real-world evidence derived from outcome registries represents a key aspect of the ongoing systematic assessment and future development of neurostimulation devices.The objective of the present study was to assess the long-term effectiveness of neurostimulation as a treatment for spinal chronic pain.The patients analyzed in the present study represent a singlecenter cohort of 52 individuals. Primary outcome measures included numeric pain rating scale, Beck depression index II and Oswestry disability index variation from baseline to 36-month visits. Secondary outcomes included its evaluation at 6-month, 12-month and 24-month visits.A significant improvement in targeted pain, depression and disability values were observed at 36-month follow-up . Those results were consistent in the leg and back pain subgroup but not in the neck, chest and arm pain subgroup. The decrease in pain, depression and disability values happened progressively through time, with the exception of the 12-month visit, where a mild stagnation was observed.Our results suggest that spinal cord stimulation is an effective long-term treatment for spinal chronic pain in real-world conditions when applied to a variety of patients and conditions usually seen in routine practice. Nevertheless, some fluctuations may occur during treatment so prolonged follow-up periods should be considered before rendering an unsuccessful therapy diagnosis. •Spinal cord stimulation is a treatment option for spinal chronic pain.•Real-world evidence from large registries regarding its effectiveness is needed.•Long-term improvement in pain, depression and disability can be achieved.•Fluctuations during treatment may occur, but do not limit the potential benefit. SpecifiA myriad of treatment modalities for chronic pain have been developed over the centuries, including both pharmacological and non-pharmacological approaches . In thatAmong those therapeutic options, neurostimulation therapy has been classically reserved for those patients with intractable pain that have not responded to pharmaco-logical and/or other conservative therapies . Spinal When recommending SCS as a treatment option for chronic pain, some authors express their reservations regarding the limited data on effectiveness beyond 12 months of follow-up, where some tapering of the effects have been reported .The objective of the present study was to assess the long-term (up to 3 years) effectiveness of SCS as a treatment for chronic pain in routine clinical practice at a high-volume Spanish hospital.22.1The present was a prospective, single-center study meant to collect the characteristics of the actual clinical outcomes of Boston Scientific's  commercially licensed neurostimulation systems for pain in routine clinical practice. The study retrieved information from patients that received a permanent SCS implant for pain control. The approval from our center's ethics committee (EC) and written informed consent from every patient included in the study, delivered in Spanish, were obtained.2.2Key inclusion criteria included adults (age 18 or older when written informed consent is obtained), who are scheduled to be trialed, on-label, with a commercially approved neurostimulation system for pain and who are willing and able to comply with the study requirements and sign a valid, EC-approved informed consent form.Key exclusion criteria included patients with any contraindication for SCS system implantation or currently diagnosed with cognitive impairment, or exhibiting any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments.2.3Before implantation, patients underwent a psychological assessment carried out by a professional psychologist where the ability to assume the management of the device, the presence of severe psychological disorders as well as unresolved issues of secondary gain were evaluated. The SCS electrodes and stimulators were implanted following the standard technique according to the product manuals. A trial period with placement of the SCS leads powered by an external neurostimulator prior to implantable pulse generator (IPG) activation was performed. Patients whose neurostimulation test was unsuccessful -defined as either pain reduction from baseline of less than 3 numeric pain rating scale (NPRS) points or describing paresthesia as uncomfortable and disagreeing to proceed to permanent implant- or who have not undergone IPG implantation at 12 months after the neurostimulation trial visit will terminate their participation in the registry.Follow-up evaluations were carried out at baseline, 6-, 12-, 24- and 36-months visits.2.4The primary outcome was change from baseline in pain intensity, Beck depression inventory-second edition (BDI-II)  and OswePain intensity was measured by the NPRS, an 11-point scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. The BDI-II includes 21 items valued on a 4-point Likert scale ranged from 0 to 3, according to the intensity in the preceding two weeks. Total score ranged from 0 to 63, with higher scores indicating greater symptoms’ severity . The ODIAdditional outcomes measures were assessed by means of the paresthesia coverage percentage, the development of new areas of neurostimulation-amenable pain, the patient global impression of change (PGIC), clinician global impression of change (CGIC) and subject satisfaction with stimulation treatment (SST) at all follow up time points.Variables regarding basic demographic, medical history, physical exam and implantation/activation procedures were also collected in order to better define our cohort's characteristics. Adverse events and device components deficiencies were also monitored throughout the study.No data imputation was performed if the patient missed any visit.2.5Baseline characteristics were presented using appropriate descriptive statistics.t-test or the repeated measures analysis of variance (ANOVA) with post-hoc Bonferroni corrections for multiple comparisons. Mauchly's sphericity test was used for testing sphericity and the Greenhouse-Geisser correction was used in the case of lack of sphericity. For continuous non-parametric data, Wilcoxon signed-rank test was employed. Cochran's Q with post-hoc corrections for multiple comparisons was used to compare differences between more than two proportions. Non-parametric ordinal data was assessed with Spearman's (rho) rank-order test.Continuous parametric data were presented as mean ± SD and analyzed using the paired Student Linear regression model was built to evaluate the influence of independent variables such as age, gender, time from pain onset to implantation, previous spine surgeries, medication, diabetes, smoking, BMI, targeted pain, SF-MPQ, BDI-II and ODI values at baseline on the difference in pain intensity measured with NPRS from baseline to 36-month visit (dependent variable). Durbin-Watson test was used to detect autocorrelation in the residuals. In addition, the presence of collinearity was discarded using the variance inflation factor (VIF). To find evidence of heteroskedasticity we employed the Breusch-Pagan test.The level of significance was defined as P < 0.05. All statistical analysis were performed using SPSS® Version 20 .3Between November 2013 and April 2016, a total of 75 patients were screened for their inclusion in the study. Of them, 74 were implanted and subjected to a neurostimulation trial that resulted successful in 70 cases. The cohort used in the analysis was constructed after subtracting the patients withdrawn from the study, dead during follow-up and those that missed the 36-month visit. The flow diagram of the cohort generation is depicted in 3.1Results regarding demographic, medical history, physical exam and implantation/activation procedures' data are summarized in 3.2When the whole cohort of patients was considered, targeted pain intensity, BDI-II and ODI scores significantly decreased from baseline to 36-month visit after implantation .In the subgroup of patients in whom the indication for neurostimulation was either back and/or lower extremity pain, back and leg pain intensity along with BDI-II and ODI scores also decreased significantly . Nevertheless, in the subgroup of patients suffering from neck and/or upper extremity pain, only the arm pain intensity showed a statistically significant reduction from baseline to the 36-month follow-up visit (P = 0.020) .Fig. 2EvResults regarding primary outcome measures are summarized in 3.3Shortly, after analyzing pain intensity and ODI scores change at 6, 12 and 24-month, along with BDI-II scores change at 12-month follow-up visit after implantation, we ob-served a significant decrease of pain intensity and ODI for both the whole cohort and the back and/or leg pain cohort at 6, 12 and 24-month visits see . Change When considering the patients implanted because of neck and/or upper extremity pain, changes in pain intensity, ODI and BDI-II resulted non-significant at all three time points, with the exception of ODI at 12-month and arm pain at 24-month visits (P = 0.038 and P = 0.011 respectively).3.4Briefly, paresthesia coverage of targeted pain area did not show a significant change at any follow-up time point (P = 0.490). Conversely, the development of new neurostimulation-amenable pain areas since implantation decreased along the study period (P = 0.025). By means of pairwise comparison, significant differences were detected only between 6 and 36-month visits (P = 0.028).Both PGIC and CGIC values showed non-significant correlation with follow-up periods .Regarding SST dimensions, none showed a statistically significant correlation with follow-up time points. The comfort of the stimulation, the amount of painful areas covered and the overall satisfaction with the stimulation therapy dimensions of the SST did not show a significant correlation with follow-up visits .3.5During follow-up a case of lead migration, a case of unsuccessful lead implant, a case of high impedance , a case of lumbosciatic pain potentially related to the device (managed with medication) and a case of implant site infection  were retrieved. All five patients were able to reach the 36-month follow-up evaluation.3.6Opioid treatment and targeted pain intensity at baseline were identified by the linear regression model to be the independently associated with greater changes in targeted pain intensity from baseline to 36-month visit . Statistically significant heteroskedasticity was discarded by means of the Breusch-Pagan test (P = 0.146). Detailed information about the model and the rest of the independent variables is summarized in 4The present study assesses the long-term effectiveness of SCS in routine clinical practice as an option for chronic back and neck pain. The results confirmed the effectiveness of SCS for as long as 36 months after implantation.NPRS has been recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus group to measure pain in clinical trials  and, morThe IMMPACT consensus has also recommended considering 6 core outcome do-mains when assessing chronic pain therapies . In the The significant reduction in NPRS, BDI-II and ODI scores accounts for the improvement of patients in the physical, psychological and functional spheres. In fact, the mean difference for ODI values were over 15 points, a frequently used criterion of clinically significant improvement . LikewisRegarding the intermediate follow-up visits at 6, 12 and 24 months, a significant, though more subtle, improvement in pain intensity and ODI values were also observed, especially when considering the 6- and 24-month visits. Interestingly, at 12 months, a mild stagnation in improvement was detected. It was more evident in the case of the BDI-II scores, that practically returned to levels similar to those observed at baseline. Classically, neuromodulation therapies have been thought to lose their effect over time. However, our observations suggest that studies with limited follow-up periods could come to identify temporary stagnation as a misleading tapering of the effects .In recent years, several authors have tested different SCS systems in order to evaluate its efficacy and effectiveness for chronic pain  . Some ofResponder definitions are typically required within regulatory review because of their capacity to quantify treatment benefit and assess the meaningfulness of changes on the outcome measures. . HoweverTherefore, in our study, mean targeted, leg and back pain decrease from baseline to 36-month visit would be classified as moderately-important-to-substantial changes.Our results showed a steady percentage of paresthesia coverage of the targeted pain area. Minor, non-significant, fluctuations were observed along follow-up. That suggests that paresthesia coverage is not a parameter that needs to be progressively increasing in order to achieve progressively lower pain intensity results over time.The results regarding PGIC and CGIC indicate that improvement brought up by SCS was patent for both the patient and the clinician since very early during treatment. Those high levels of improvement perception were maintained during long-term follow-up.Regarding patient's SST, a great majority (more than 80%) of patients agreed, up to some extent, on a comfortable sensation of the stimulation along with a sufficient amount of painful areas' coverage and the overall satisfaction with therapy. The fact that those high levels of satisfaction were present since the first follow-up visit was in consonance with the significant improvement in pain intensity, BDI-II and ODI values already evident at that same time point. These observations accounts for the early and maintained effect of SCS therapy, that remained despite the above-mentioned fluctuations in pain intensity, BDI-II and ODI scores over time. In our opinion, that should support the maintenance of SCS treatments despite momentary stagnation or regression along follow-up.Our study identified two factors independently associated with greater changes in targeted pain intensity by means of a linear regression model. The fact that one of these factors was the targeted pain at baseline would be explained by the greater margin for improvement that patients with higher pain intensities would have after implantation of the SCS system.The logistic regression model also identified an increased reduction in pain intensity in those patients on opioids before SCS therapy. In line with the previous argument, it is more likely that patients with higher pain scores would require opioids in their treatment and, therefore, have greater margin for improvement when introducing SCS. Nevertheless, since opioids have a limited effect on neuropathic pain  and neurTaking all together, the results rendered by our regression model could correspond to those patients with the highest targeted pain scores at baseline that, consequently, required opioids as part of their treatment. Therefore, identifying those patients with higher pain intensities could help to offer SCS to those with the greatest potential benefit and, also, to potentially reduce the opioid prescription.4.1The limited number of patients, along with the fact that it represents the experience of a single center, prevents the generalization of the results obtained in the present study. Moreover, some of the results observed corresponded to a very small subgroup of patients . We believe that, despite limited, our results could account for the consideration of including subgroup analysis regarding indication for neurostimulation in future studies. Future work on the subject could help us to elucidate whether there are technical, anatomical or physiological conditions that limit the effectiveness in the case of cervical electrodes.The fact that we only used Boston Scientific's SCS systems contributes to the limited generalization of the assumptions extracted from the present article to other commercially available systems. Further studies assessing effectiveness of SCS in routine clinical practice should address this limitation.The absence of a control group makes it impossible to distinguish the effect of SCS from the mere effect of time and spontaneous improvement on the outcome measures. Likewise, since this was a single-branch study, no comparison between different types of SCS could be performed. The net benefit provided by the Boston Scientific's systems in comparison with other systems available on the market could, therefore, not be elucidated.5The results obtained in the present study confirm the long-term effectiveness of SCS for the treatment of chronic pain, particularly leg and back pain. Changes in pain intensity from baseline to 36-month follow-up were moderately significant to substantial in magnitude. Likewise, the decrease in ODI and BDI-II scores were clinically significant after 24 and 36 months of follow-up respectively. Analyzing the evolution of the outcome measures throughout the follow-up period, we observed a stagnation of the improvement at 12 months. However, after that time, the patients continued to improve until the end of the 36-month follow-up. In our opinion, this plateau phase in the improvement curve should not discourage clinicians or patients when assessing the full potential effect that SCS treatment can provide in each case.Instituto de Investigación Carlos III to MLGG, and grant B2017/BMD-3688 from the 10.13039/100012818Community of Madrid to MLGG.This work was supported in part by grant PI2017/00361 from The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Ethics Committee of Hospital Universitario La Paz .Informed consent was obtained from all subjects involved in the study.https://www.bostonscientific.com/).The data and study materials for this clinical study will be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (Carlos III Health Institute. Maria Luisa Gandia Gonzalez reports financial support was provided by 10.13039/100012818Community of Madrid. Maria Luisa Gandia Gonzalez reports a relationship with Boston Scientific Corporation that includes: consulting or advisory. Jose Francisco Paz Solis reports a relationship with Boston Scientific Corporation that includes: consulting or advisory.The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Maria Luisa Gandia Gonzalez reports financial support was provided by


In the Laitinen scale, the differences were insignificant, although the size distribution was similar. (4) Conclusions: The therapy used in this study showed that magnetic stimulation plus LED therapy and the use of Traumeel S ointment gave positive results in terms of pain reduction in each of the study groups. The strongest analgesic factor seems to be magnetic and LED therapies used separately. Traumeel S in magnetoledophoresis does not work synergistically with the magnetic field of LED light, and even worsens the effect of the therapy used.(1) Background: The aim of the study is to evaluate the analgesic effectiveness of a physical therapy regimen that combines the use of an electromagnetic field with light radiation emitted by LEDs, along with the use of Traumeel S ointment, in patients with gonarthrosis. (2) Methods: The study included 90 patients with knee osteoarthritis (grade 2 Kellgren and Lawrence osteoarthritis). They were divided into three groups: Group I, 30 patients treated with magnetic stimulation plus LED therapy; Group II, 30 patients treated with Traumeel S ointment; and Group III, 30 patients treated with magnetic stimulation plus LED therapy with Traumeel S ointment. Pain intensity was assessed using the VAS and Laitinen scales before and after a series of treatments. (3) Results: Significant results in terms of pain reduction before and after treatment were obtained in each of the study groups, as there were significant differences in the VAS pain intensity scores before and after the procedures between the groups. In group I, with electromagnetic field and LED light treatment, the difference was 35.5; in group II, which received Traumeel S Osteoarthritis (OA) is a slow, progressive, premature usage and degeneration of the tissues that make up the joints. OA is one of the most common diseases affecting the musculoskeletal system, which in turn leads to the degeneration of the articular cartilage, the subchondral layer of the bone, and as a result, it affects all layers forming the joint. Osteoarthritis of the knee joints  is the third most frequently occurring form of osteoarthritis, behind osteoarthritis of the hip and spine joints .The disease especially affects the elderly, and the incidence rate increases with age. It mainly affects people aged 65–74, which represents 10–20% of the world’s population, while after the age of 75, the incidence rate increases to 40% . EtiologInterestingly, obesity is also associated not only with osteoarthritis of the hips but also of the hands. This indicates that excess adipose tissue produces humoral factors, altering the metabolism of articular cartilage. It has been postulated that the leptin system may be a link between metabolic abnormalities in obesity and an increased risk of osteoarthritis .Current diagnosis and treatment of knee osteoarthritis (KOA) is based mainly on clinical and imaging symptoms, ignoring its molecular pathophysiology. The mismatch between the molecular characteristics of the patients and the mechanisms of drug therapy may explain the failure of some disease-modifying drugs in clinical trials .One of the most important elements in preventing the development of knee osteoarthritis is physiotherapy. In the fight against OA, the most effective treatment is rehabilitation that is well matched to the patient , taking into account both traditional kinesiotherapy and physical therapy. An important consideration is to relieve the knee joint by avoiding carrying heavy objects or wearing properly selected orthopedic equipment  and, above all, by controlling body weight ,8.Among the many treatments available, the most effective form of therapy to relieve pain and minimize degenerative progress in KOA is still being sought. In this context, it is interesting that plant extracts and their metabolites can affect diagnostic and prognostic KOA biomarkers ,10.Magnetic field LED therapy is common physical therapy modality with a high therapeutic efficacy, due to the combined effects of extremely low frequency electromagnetic fields (ELF-EMFs) and high-power light emitted by light-emitting diodes (LEDs) ,12.The importance of physical methods in therapy is constantly increasing due to their effectiveness, low cost, and the high degree of patient acceptance for this form of treatment. Magnetophoresis is a transdermal method  for supporting drug penetration through biological barriers, which was used together with ketoprofen gel, achieving a positive analgesic effect that persisted even after 30 days  . The assTraumeel S is an ointment that works based on plant and mineral ingredients in a different way than do NSAIDs. It has been found that Traumeel S reduces the activity of NADPH oxidase and extracellular neutrophil traps, and also induces an anti-inflammatory effect on lymphocyte subpopulations .®) contains 1.5 g Arnica montana; 0.45 g each calendula officinalis and Hamamelis virginiana; 0.15 g each Echinacea purpurea, Echinacea angustifolia, and Chamomilla recutita; 0.1 g each Symphytum officinale and Bellis perennis; 0.09 g each Hypericum perforatum and Achillea millefolium; 0.05 g each Aconitum napellus D1 and Dummy belladonna D1; 0.025 g Hepar sulfuris; and 0.04 g Mercurius solubilis Hahnemanni. The base of the ointment is a hydrophilic substance, DAB 10, preserved with 12.5% ethanol. Its effectiveness was determined in a study by González et al. in which it was compared with diclofenac. In rare cases, reactions associated with individual hypersensitivity may occur in the form of local allergic reactions . In this case, the drug should be discontinued and, if necessary, treatment of these symptoms should be initiated [The ointment relieves pain and swelling and reduces inflammation in the case of minor injuries. In terms of its composition, 100 g of ointment  aged 31–87 years. The research was conducted at the Rehabilitation and Physical Medicine Clinic of the Medical University of Lodz in the years 2013–2018. Patients were enrolled in the study after clinical and radiological examination, following exclusion and inclusion conditions. Each patient was assigned to a group based on the order of admission to the clinic.The study was authorized by the Bioethics Committee for Scientific Research at the Medical University in Lodz, number RNN/726/12/KB.-Patients diagnosed with grade 2 osteoarthritis of the knee on the Kellgren and Lawrence scale;-Confirmation of OA through a standing X-ray of the knees (not older than 6 months);-No allergies to topical herbal ointment;-Absence of hypersensitivity reactions to magnetic fields and red light;-No contraindications to the therapy from other systems;-Consent to examination procedures.-Restrictions on the application of a magnetic field;-Sensory disorders;-Presence of conditions that may affect the condition of the affected joints, such as diabetes and neuroarthropathies;-Lack of patient and guardian permission for the examinations and programme participation.Patients were divided into 3 groups.Group I—30 patients who were treated with an electromagnetic field and LED light;® ointment;Group II—30 patients who were treated with Traumeel SGroup III—30 patients who were treated with an electromagnetic field and LED light as well as with Traumeel S ointment.The division into groups depended on the order of admission to the hospital. Treatment eligibility was assessed by the same doctor and physiotherapist.Treatments and exercises were performed 5 times a week (15 treatment days on average). Kinesiotherapy consisted of weight-bearing and weight-bearing with resistance exercises. During a three-week stay in the hospital, on the first and last day, patients underwent clinimetric assessment using the VAS   method aThe study involved an electromagnetic field combined with light radiation emitted by LEDs generated by the Viofor JPS System from Med.&Life, Poland , with th2. It produces a magnetic field induction (peak) of 50 μT–1200 μT and a magnetic field frequency of 0.08–195 Hz. Monochromatic light is not as powerful as laser light and is eye-safe [The applicator used is an oval-shaped device that simultaneously emits a magnetic field and red light through LEDs. It has a maximum radiation power of 210 mW in a single pulse and the application area is about 20 cmeye-safe .p = 0.05. For the variables “VAS score”, “Leitinen questionnaire score”, and “Lequesne index score”, a generalized linear model (GLM) was constructed, taking the values of a given variable before and after treatment as dependent variables and the type of treatment as qualitative factors.In order to answer the research questions, statistical analyses were performed with STATISTICA StatSoft Polska 2020 . Descriptions of clinical parameters are presented in the median  format. Kruskall–Wallis and Dunn tests were used to compare treatment effects between the groups. The Wilcoxon test was used to compare the significance of differences in parameter values before and after treatment. The significance level was The results of the study are shown in the figures below, where the numerical values before and after treatment in each group are given . A compaAll patients evaluated together show highly significant improvement in pain intensity assessed by the VAS .All patients evaluated together show highly significant improvement in pain intensity assessed by Laitinen scale .In each of the studied groups, a significant difference in the intensity of pain before and after treatment is observed . In addiIn each of the studied groups, a significant difference in the intensity of pain before and after treatment is observed . There wThe comparison of the magnitude of improvement shows the greatest reduction in pain intensity in group I, then in group III, and the smallest reduction in group II, which means the greatest improvement on the VAS scale occurred after LED therapy. A similar size distribution is observed on the Laitinen scale, except that there are no statistically significant results here. However, the results of group III do not confirm the assumptions about the synergism of combined transdermal therapy.No adverse symptoms were observed in patients in any of the study groups.The purpose of this study was to evaluate and compare the effectiveness of an electromagnetic field combined with light radiation emitted by LEDs and Traumeel S ointment on physiotherapy results in patients with knee osteoarthritis, as measured by the VAS and Laitinen scale. Patients with radiological grade 4 OA on the Kellgren and Lawrence scale were excluded from the study. The severity of the lesions did not respond to any of the conservative treatment methods. Patients with such severe changes were referred for surgical treatment. Comparing all groups of patients included in the study, we can conclude that each treatment method significantly changed the values of the parameters in both scales used. The group of patients with the greatest positive results in terms of pain reduction was the group of patients that received ELF-EMF and LED light treatment. The second-greatest pain reduction was experienced by the group of patients who received ELF-EMF and LED light treatment as well as Traumeel S ointment.With respect to the electromagnetic field and LED light treatment, many authors in their articles have confirmed the analgesic effectiveness of this treatment. ELF-EMF and LED light is a treatment using optical radiation from the visible and infrared light spectrum, which is produced by high-energy LEDs (light-emitting diodes). LEDs emit light radiation in the red (R), infrared (IR), as well as mixed (RIR) light spectrum that is distinguished by its monochromaticity and incoherence. The biological effect of LED therapy is mainly related to the effect of heat on tissues. This causes, among other things, dilation of skin capillaries, increased metabolism and healing processes, reduction in skeletal muscle tension and, importantly, an increase in one’s pain threshold. The body’s response to IR can be local or global, depending on the amount of energy absorbed. Monochromatic light applicators can emit radiation with wavelengths similar to those of laser radiation, but without coherence and polarization effects. The density and energy of the light beam are high enough to induce photostimulation, but without the danger of tissue damage that laser radiation poses, as well as other side effects associated with high-energy wavelengths. Thus, LED therapy, in terms of therapeutic doses, replaces laser therapy with a scanner, without having to comply with health and safety regulations required for the use of lasers ,14,19,20The second important element in the study was the use of Traumeel S ointment in patients with OA. This drug works with plant and mineral ingredients in a way that is different from analgesics and non-steroidal anti-inflammatory drugs. A meta-analysis of the data showed that natural products inhibit the expression of syndecan IV, MMP1, MMP3, MMP19, ADAMTS-4, ADAMTS-5, iNOS, COX-2, collagenases, TNF-α, IL-1β and IL-6 in vitro and in vivo. Cytokines also increase the expression of collagen II and aggrecan. Extracts and isolated compounds that affect major signaling pathways include SIRT, MAPK, AMPK, NLRP3, PI3K/AKT, mTOR, NF-κB, WNT/β-catenin, NRF2 and JAK/STAT3. They also affect modes of cell death such as apoptosis, autophagy, pyroptosis and ferroptosis. The plants from which these medicines are derived are used in the production of Traumeel S ointment and gel. The ointment acts supportively after injuries such as joint sprains, minor injuries , and in cases of muscle and joint pain. It relieves pain and swelling and reduces inflammation in traumatic injuries . Many auNevertheless, the study shows an improvement in pain when the ointment is used as a sole analgesic, which has already been discussed in some papers ,27, and ® gel instead.A limitation of this study is the subjective assessment of pain, although it was expressed in two scales. It is advisable to objectify the data in the study of the patients’ condition using functional scales and muscle strength tests, which is planned for a future publication of the continuation of this study. It is also worth conducting a follow-up examination 30 days after the end of the examination, bearing in mind the effect of biological hysteresis that occurs after magnetophoresis . A shortThe applied therapy showed that treatment involving an electromagnetic field combined with light radiation emitted by LEDs and the use of Traumeel S ointment gives positive results in reducing pain. Whether they are used individually or together, the indicated elements of the therapy provide significant pain reduction. The most potent analgesic factor seems to be ELF-EMF and LED light used separately. Traumeel S in magnetoledophoresis does not act synergistically with the magnetic field, which is probably due to the type of substrate applied in the ointment and the type of organic, plant-derived ingredients used. It would be advisable to conduct similar studies with a preparation that has a different base, i.e., with the Traumeel S gel produced by the company. Traumeel S ointment, on the other hand, may be an alternative to topical NSAIDs.


Mixed hemorrhoids are a common anorectal disorder, surgery is the most effective means of eradicating hemorrhoids, and pain is the most common postoperative complication of mixed hemorrhoids.  To compare the clinical efficacy of auricular plaster, acupoint application, and acupoint catgut embedding for treating postoperative pain in mixed hemorrhoids.  PubMed, Embase, The Cochrane Library, Web of Science, CNKI, Wanfang, VIP, and CBM databases were searched for randomized controlled trials (RCTs) of three acupuncture-related therapies for postoperative pain in mixed hemorrhoids from the time of database creation to October 2021. After screening the literature, extracting information, and evaluating the risk of bias of included studies, statistical analysis was performed using RevMan 5.3 and Stata 15.0.  Forty-seven RCTs with a total of 5121 patients were included. Network meta-analysis (NMA) showed that auricular plaster ) and acupoint catgut embedding therapy ) were more effective than analgesics in the treatment of postoperative pain in mixed hemorrhoids. The cumulative ranking probability (SUCRA) showed that acupoint application (73.6%) had the best overall efficacy and the rest were auricular plaster (68.7%), acupoint catgut embedding therapy (64.6%), auricular plaster combined with acupoint application (63.4%), and pain medication (8.9%) in that order. Secondly, auricular plaster ), acupoint catgut embedding ), and acupoint application ) all led to a significant decrease in pain scores and were all more effective than analgesics. As ranked by SUCRA, the results showed that the efficacy of acupoint application (73.5%) was optimal and the rest were auricular plaster (56.1%), acupoint catgut embedding (50.2%), and pain medication (15.3%) in that order. In terms of pain degree, acupoint application ) was significantly better than pain medication.  Acupoint application can improve the overall efficiency, reduce pain scores, and relieve the degree of postoperative pain in mixed hemorrhoids. Mixed hemorrhoids are a common anorectal disease , surgeryIn clinical practice, drug therapy is mostly used for postoperative pain in hemorrhoids but it requires multiple doses within a short period of time, which easily causes adverse reactions in the gastrointestinal tract and central nervous system, often resulting in dizziness, nausea, vomiting, dry mouth, and itchy skin –7, and tAcupuncture is an important part of Traditional Chinese medicine, and acupuncture mainly includes auricular plaster, acupoint application, and acupoint catgut embedding, compared with conventional acupuncture, which is simple to operate, saves consumables and time cost, and can avoid the pain caused by applying regular acupuncture to patients. However, there is a lack of comparative studies on the efficacy of the three treatment methods and it is difficult to obtain a clear comparison by traditional meta-analysis. In this study, NMA was used to screen the best therapeutic measures based on ranking efficacy indexes for postoperative pain in hemorrhoid treatment in acupuncture to provide a reliable evidence-based reference for the clinic.PubMed, Embase, The Cochrane Library, Web of Science, CNKI, Wanfang, VIP, and CBM databases were searched from the establishment to October 2021 to find clinical randomized controlled trials about 3 acupuncture therapies, auricular plaster, acupoint application, and acupoint catgut embedding, for the postoperation pain of mixed hemorrhoids. PubMed was used as an example, and a combination of subject terms and free words were used for the search. The search strategy is shown in To be eligible for inclusion, the following criteria had to be fulfilled: (1) study design: RCTs; (2) study population: patients with postoperative pain in mixed hemorrhoids. Gender, age, and source of disease cases were not limited, and the mode of surgery and the degree of disease were not limited; (3) interventions: auricular plaster, acupoint application, and acupoint catgut embedding (can be one or more therapies combined) for the observation group and analgesic drugs or conventional treatment for the control group; (4) outcome indicators: the main indicators: (i) total effective rate, (ii) pain score, and (iii) pain degree; secondary indicators: (i) complications and (ii) adverse reactions; (5) efficacy evaluation criteria: (i) visual analog scoring VAS score, (ii) international standard pain assessment numerical grading method NRS, (iii) Changhai Pain Scale, (iv) WHO pain degree grading standard, divided into 0—III, and (v) numerical rating scale NRS score; and (6) Chinese Pain Society Han Jisheng recommended VAS.The following are the exclusion criteria: (1) study subjects: patients with combined postoperative pain from perianal diseases other than mixed hemorrhoids; (2) intervention: patients with combined herbal or proprietary Chinese medicine treatment; (3) experience, case reports, reviews, animal experiments, and case retrospective studies; (4) conference papers or dissertations, etc.; (5) repeatedly published literature; (6) outcome indicators: none or imperfect; and (7) the original text of the study not being obtainedThe retrieved literature records were managed using reference management software NoteExpress (version3.2). Based on the inclusion and exclusion criteria, two independent researchers conducted a detailed screening of titles and abstracts of reference records identified through database searching. All potential articles that meet the eligibility criteria and controversial literature were required for a full-text review. The third researcher will conduct the arbitration, who was responsible for resolving the conflict between the two researchers. A total of 924 relevant papers were obtained from the initial review, and 47 RCT studies were finally included after the stratified screening .Two investigators assessed the quality of the included studies according to the Cochrane Risk of Bias Assessment Tool recommended in the Cochrane Systematic Assessment Manual, version 5.1. The Cochrane Risk of Bias Assessment included seven aspects: randomization methods, blinding of participants and investigators, blinding of evaluators, allocation concealment, completeness of outcomes, selective reporting of outcomes, and other sources of bias. Bias was assessed for each of the included RCTs in terms of low risk, high risk, and unclear . Any incAn Excel sheet database was set up to extract study information, including authors, year of publication, gender of study subjects, age, sample size, intervention measures, outcome indicators, complications, adverse events, surgical methods, and anesthesia methods.I2 ≤ 50%, P ≥ 0.05 was considered as no statistical heterogeneity in the included literature, and the meta-analysis was performed using the fixed-effect model; I2 > 50% or P < 0.05, the included literature was statistically heterogeneous, and a random-effects model was used for meta-analysis.The risk bias was evaluated using RevMan 5.3 software. The included literature was compared directly using Stata 15.0 software, P < 0.05.The ranking between interventions was obtained by direct and indirect comparisons using Stata 15.0 software, with odd ratios (OR) for dichotomous variables and standardized mean difference (SMD) and 95% credible intervals (CI) for continuous variables. The closed loop formed by studies with both direct and indirect evidence was performed to test inconsistency, the surface under the cumulative ranking curves (SUCRA) closer to 100%, the better the efficacy of the intervention, and the difference is considered statistically significant at A total of 5121 cases were included in 47 –54 studi47 literature were all two-arm studies. 34 studies , 48, 49 P < 0.05) (P < 0.05) ), auricular plaster ), and acupoint application ) were superior to conventional treatment. Among the three, the efficacy of acupoint application was more significant ( < 0.05) . Acupoin < 0.05) .P < 0.05) (P < 0.05) ), acupoint catgut embedding ), and acupoint application ) were better than conventional treatment, and auricular plaster was more effective ( < 0.05) . Acupoin < 0.05) .The total effective rate was included in 14 studies , 42, 47 A total of 34 papers , 48, 49 P < 0.05 ) and acupoint catgut embedding ) had higher total efficiency than painkillers. Auricular plaster ) was superior than conventional treatment, and the differences were all statistically significant, P < 0.05 .The efficacy ranking was based on cumulative SUCRA, and the larger the area, the better the efficacy. The results of SUCRA ranking showed that acupoint application (73.6%) > auricular plaster (68.7%) > acupoint catgut embedding (64.6%) > auricular plaster combined with acupoint application (63.4%) > conventional treatment (20.9%) > painkillers (8.9%) .In terms of pain score reduction, auricular plaster ), acupoint catgut embedding ), and acupoint application ) were superior to painkillers. Auricular plaster ), acupoint catgut embedding ), and acupoint application ) were superior to conventional treatment.P < 0.05 ), acupoint catgut embedding ), acupoint application ), conventional treatment ), and painkillers ); all differences were statistically significant, P < 0.05 .The results of the area under the curve (SUCRA) ranking showed that auricular plaster combined with acupoint application (99.5%) > acupoint application (73.5%) > auricular plaster (56.1%) > acupoint catgut embedding therapy (50.2%) > pain medication (15.3%) > conventional treatment (5.3%) .P < 0.05 ) and acupoint application ) were better than conventional treatment and acupoint application ) was better than painkillers; all differences were statistically significant, P < 0.05 .P < 0.05 (The results of the area under the curve (SUCRA) ranking showed that acupoint application (91.2%) > auricular plaster (66.1%) > auricular plaster combined with acupoint application (54.6%) > painkillers(36.6%) > acupoint catgut embedding (34.8%) > conventional treatment (16.8%); all differences were statistically significant, P < 0.05 .P < 0.05  > auricular plaster (69.6%) > acupoint catgut embedding (65.8%) > painkillers(21.5%) > conventional treatment (6.6%) . RegardiP < 0.05 . The resP < 0.05 .P < 0.05 , 48 h, SMD = −1.14, 95%CI = , and 72 h, SMD = −1.80, 95%CI =  all played a pain relief effect, with the 72 h efficacy being more effective. In the control group with analgesics, 24 h, SMD = −1.33, 95%CI = , 48 h, SMD = −1.33, 95%CI = , and 72 h, SMD = −2.12, 95%CI =  after the intervention had an analgesic effect, the efficacy of 72 h was more visible, and all differences were statistically significant,  Figures .Because 34 of the 47 publications reported pain scores, this study used pain scores as an outcome indicator to test for small sample effects or publication bias and the funnel plot showed that most of the study scatters were located between the funnel plot and were more symmetrical, suggesting that there may be a small publication bias .This study is aimed at discussing the efficacy of three different acupuncture therapies  for postoperative pain in mixed hemorrhoids. 47 RCTs involving 5121 patients were included in this study. The results of the NMA showed that auricular plaster, acupoint application, and acupoint catgut embedding were superior to pain medication and conventional treatment in improving the overall efficiency and the ranking results showed that acupoint application was the most effective. Reducing postoperative pain scores, auricular plaster, acupoint application, and acupoint catgut embedding were superior to pain medication and conventional treatment. Auricular plaster combined with acupoint application was probably the most effective, followed by acupoint application.However, of the 47 studies included in this study, only 3 , 32, 46 Nowadays, medical treatment of postoperative pain in mixed hemorrhoids mostly uses opioid analgesics, nonsteroidal anti-inflammatory drugs, central analgesics, etc. Although the pain relief effect is good, drug side effects such as nausea, dizziness, vomiting, and sweating can easily occur , 57, witThis study showed that the efficacy of acupoint application for postoperative pain in mixed hemorrhoids was more advantageous compared with other therapies. In fact, the mechanism of acupoint application for postoperative pain in mixed hemorrhoids is more widely studied, which may be related to its good efficacy. Acupoint application is based on the guidance of Chinese medicine meridian science, and the drug is applied to specific points on the body surface, both for acupuncture point stimulation and for absorbing the active ingredients of the drug through the skin tissue, producing a local concentration of the drug and playing the dual role of Chinese medicine and meridian regulation at the same time. Medical research has shown that trans-acupoint application drugs have permeability, exosensitivity, and amplification effects .This study showed that the efficacy of acupoint application for postoperative pain in mixed hemorrhoids was more advantageous compared with other therapies. In fact, the mechanism of acupoint application for postoperative pain in mixed hemorrhoids is more widely studied, which may be related to its good efficacy. Acupoint application is based on the guidance of Chinese medicine meridian science. The drug is applied to specific points on the body surface, both for acupuncture point stimulation and for absorbing the active ingredients of the drug through the skin tissue, producing a local concentration of the drug and playing the dual role of Chinese medicine and meridian regulation at the same time. Medical research has shown that trans-acupoint-applied drugs have permeability, exosensitivity, and amplification effects . AnotherAs a part of Chinese traditional medicine, acupuncture therapy has the advantages of precise efficacy, low toxic side effects, and easy acceptance by patients. In recent years, acupuncture therapy has gradually become the mainstream of global medicine as a green alternative or complementary treatment , 64. ComThis study still has shortcomings, such as the lack of systematic and standardized methods for making homemade acupoint-applied plasters and the need to further standardize the methods for making acupoint-applied plasters. The methodological quality of the included studies was low, most of the studies did not mention the distribution concealment method, and due to the specificity of acupuncture therapy, most of the studies were not implemented blinded, which may produce implementation bias; in order to reduce bias and make the results more reliable, in the future, researchers should follow the CONSORT reporting standards . The conCurrent evidence suggests that acupoint application therapy for the treatment of postoperative pain in mixed hemorrhoids has better efficacy in improving overall effectiveness and reducing pain scores as well as relieving pain levels.


Background: Limited hip internal rotation range of motion (IR-ROM) and hip abductor weakness are recognized in low back pain (LBP) sufferers. The main aim was to investigate the effect of a ultrasound (US)-guided percutaneous neuromodulation (PNM) technique on hip strength in people with LBP. A second purpose was to discover whether the location along the sciatic nerve, where percutaneous neuromodulation was applied, could influence the change of strength response in these patients. Methods: Sixty LBP sufferers were recruited and divided randomly into three groups. All participants received an isolated percutaneous electrical stimulation at one of three different locations of the sciatic nerve pathway , depending on the assigned group. Pain intensity, hip passive IR-ROM, hip muscle strength, and the Oswestry disability index (ODI) were analyzed. All variables were calculated before the intervention and one week after the intervention. Results: All interventions significantly decreased pain intensity and improved the IR-ROMs, strength, and functionality after one week (p = 0.001). However, between-group (treatment x time) differences were reported for flexion strength in the non-intervention limb (p = 0.029) and ODI (p = 0.021), although the effect size was small (Eta2 = 0.1) in both cases. Conclusions: The application of an isolated intervention of the US-guided PNM technique may be a useful therapeutic tool to increase the hip muscle strength in patients with chronic LBP. Chronic low back pain (LBP) is one of the most common musculoskeletal pains  and has Considering that exercise programs have been considered as a main intervention for hip muscle strength , innovatPlaza-Manzano et al.  carried A prospective, randomized, controlled pilot study (NCT04590443) was carried out on LBP patients, according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.The local ethics committee approved the study, which complied with all the principles set forth in the Declaration of Helsinki. All participants signed informed written consent forms to participate in this study.A convenience sample of 60 LBP sufferers diagnosed by a specialized doctor from a private clinic were recruited for this study. Participants were divided randomly (by a researcher) into three groups, each composed of 20 subjects, depending on the anatomical location for a specific stimulation: in group A, patients were stimulated in the proximal posterior thigh; in group B, patients were stimulated in the mid posterior thigh; and in group C, patients were stimulated in the distal posterior thigh. The reason for performing sciatic neuromodulation by localization was due to the fact that there are methodological questions regarding the development of this technique that are still not clear, but that are successfully applied during clinical practice. That is why the authors considered it important to demonstrate different manners that therapists apply in this technique, in order to establish adequate and scientifically justified treatment protocols.The recruitment dates were from 20 October 2020 to 10 July 2021. According to the NIH Task Force on Research Standards for Chronic LBP (CLBP), patients who had referred nonspecific lumbar pain for at least the previous six months were recruited . SpecifiThe following sociodemographic data were noted: age, weight, height, body mass index (BMI), sex, dominant side, and intervention side.In line with the previous literature ,15, whicThe clinical outcomes were one-week changes in pain intensity in the low back calculated with a numerical rating scale  and related disability measured with a specific LBP questionnaire. The Oswestry Disability Index (ODI) was used to assess lumbar back disability . A 10-itThe functional variables were one-week changes in hip IR-ROM and hip muscle strength.-Hip passive internal rotation range of motion (IR-ROM). The authors only recorded the hip IR-ROM because it is the only one that is related to low back pain [ack pain . The hipack pain . Tester -Hip muscle strength. The hip muscle strength assessments of the hip abduction, external rotation, internal rotation, flexion and extension, were analyzed using a hand-held dynamometer (HHD)  [Ut, USA) . Each meUt, USA) , and allUt, USA) . All pat®, Waukesha, WI, USA) with a high-frequency linear US transducer (12 L). Following previous authors [®, , using the PES option, and the location of the needle was different for each group  and a desired power of 80% (β error of 0.2).The SPSS 23.0 software  was used for data analysis. The Kolmogorov-Smirnov test was run for the normality assumption. The one-way analysis of variance (ANOVA) was employed to assess the sociodemographic data among groups. Two-way ANOVA was used to calculate between group difference, with time  as a within-subject factor and group  as a between-subject factor. Moreover, the Mauchly test was developed to assess sphericity, and the Greenhouse-Geisser correction was employed when the sphericity assumption was not fulfilled. The level of significance was set at The intraclass correlation coefficient (ICC) and the standard error of measurements (SEM) were used to determine the intra-researcher reliability of the measurements.p = 0.001, Eta2 = 0.806 and p = 0.001, Eta2 = 0.727, respectively) and inter-group (treatment × time) differences were not found for the pain variable. However, there were significant differences for ODI (p = 0.021), but the effect size was small (Eta2 = 0.1) and the minimum important difference was not reached (points = 17) to be clinically meaningful [p = 0.001). However, inter-group (treatment × time) interaction did not reveal significant differences for any variable. Regarding p = 0.001). Inter-group (treatment x time) differences were only found for flexion strength in the non-intervention limb (p = 0.029), although the effect size was small (Eta2 = 0.1).Throughout the study, no adverse events were recorded. aningful . The ODIThe main finding was that the application of an isolated intervention of the US-guided PNM technique increased the hip muscle strength in patients with chronic LBP, in addition to other known effects such as pain and IR-ROM improvement. According to previous study , the hypA hallmark of chronic LBP is altered biomechanics of the lumbopelvic-hip zone , charactThe authors suggest that the search for other therapeutic tools complementary to therapeutic exercise may be an interesting line of future research for the treatment of LBP sufferers. Even though most prior research in US-guided PNM has focused on pain treatment in patients ,10,11,12In this line, this is the first study applying the US-guided PNM technique with the aim of improving strength in the hip muscle in patients with LBP, while managing to improve the two biomechanical alterations characteristic of such patients: passive IR-ROM and muscle weakness. The authors reaffirm the therapeutic potential of the US-guided PNM technique, due to the extensive benefits for a multitude of important study variables in people’s daily lives. So, the relevance of this finding for clinical practice is that the US-guided PNM procedure may be prescribed as an important treatment modality in response to chronic LBP concerns. Based on our results, the US-guided PNM technique may be a complementary intervention to exercise therapy for improving hip muscle strength in LBP sufferers and therefore, relieving pain and improving related functional limitations.The authors recognize that this study has several limitations: first, this neuromodulation technique was performed independently; usually, physiotherapists apply different methods in the same therapeutic appointment to treat patients referred with chronic LBP in clinical practice. Future studies that combine different procedures including the US-guided PNM technique are needed. Second, this study did not have a group control. Previous research demonstrated the non-application of any treatment , the appThe authors suggest that the main clinical application of this study is that US-guided PNM may be considered as a neuromodulation technique to treat chronic LBP. This procedure is able to produce improvements in multitude clinical variables, including pain.The conclusion of this study was that the application of an isolated intervention of the US-guided PNM technique improved hip strength, the ROM, and the overall level of pain in LBP sufferers, independent of the anatomical point of sciatic stimulation.


Evidence for effective pain management and opioid minimization of intravenous ketamine in elective surgery has been extrapolated to acutely injured patients, despite limited supporting evidence in this population. This trial seeks to determine the effectiveness of the addition of sub-dissociative ketamine to a pill-based, opioid-minimizing multi-modal pain regimen (MMPR) for post traumatic pain.This is a single-center, parallel-group, randomized, controlled comparative effectiveness trial comparing a MMPR to a MMPR plus a sub-dissociative ketamine infusion. All trauma patients 16 years and older admitted following a trauma which require intermediate (IMU) or intensive care unit (ICU) level of care are eligible. Prisoners, patients who are pregnant, patients not expected to survive, and those with contraindications to ketamine are excluded from this study. The primary outcome is opioid use, measured by morphine milligram equivalents (MME) per patient per day (MME/patient/day). The secondary outcomes include total MME, pain scores, morbidity, lengths of stay, opioid prescriptions at discharge, and patient centered outcomes at discharge and 6 months.This trial will determine the effectiveness of sub-dissociative ketamine infusion as part of a MMPR in reducing in-hospital opioid exposure in adult trauma patients. Furthermore, it will inform decisions regarding acute pain strategies on patient centered outcomes.NCT04129086 was registered on October 16, 2019.The Ketamine for Acute Pain Management After Trauma (KAPT) with registration #  In a learning trauma care system, optimal patient outcomes are achieved through continuous learning and improvement facilitated by rapid evidence generation and innovation, implementation of evidence into care delivery, and refinement . As an eDespite these improvements, short-term opioid administration for acute pain continues to be associated with a small but substantial risk of persistent opioid use . In the Ketamine is a Federal Drug Administration approved drug that is used for general anesthesia and for procedural sedation. Ketamine can also be used for treatment of chronic pain and post-traumatic stress disorder (PTSD) , 7. MoreTo ascertain the effectiveness of ketamine for treatment of acute pain by evidence of reduced opioid consumptionTo ascertain the effectiveness of ketamine for treatment of acute pain by evidence of self-reported patient pain scoresThe Ketamine for Acute Pain after Trauma (KAPT) trial is a single-center, parallel-group, randomized, controlled comparative effectiveness trial of our MMPR to our MMPR plus a sub-dissociative ketamine infusion for the first 72 h after admission. We hypothesize that the addition of ketamine will result in lower opioid exposure in injured patients compared to our generic MMPR alone as evidenced by lower average oral MME per day. The objective of this study are:The trial is registered at ClinicalTrials.gov (Identifier: NCT04129086) and was designed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials 2013 guidelines  admitted to the adult trauma service at the intermediate or intensive level of care. Exclusion criteria include the following: pregnant women, prisoners, and those not expected to survive. Additionally, patients with the following contraindications to ketamine are excluded: allergy to ketamine, poorly controlled hypertension, cardiac arrhythmia , congestive heart failure, unstable coronary artery disease or recent myocardial infarction, cirrhosis, dementia, movement disorder , or seizure disorder. Additionally, for those unable to provide past medical history, patients are excluded if they have arrhythmia on EKG, are older than 65 years, present after fall from standing, or have median sternotomy scar. Patients in the ketamine arm may drop out of the treatment group if ketamine is stopped prematurely due to medication side effects .The intervention is minimal risk; the ketamine dosing proposed is already being used by prehospital personnel, emergency room physicians, and trauma surgeons at similar or higher doses.truly informed consent cannot be obtained in the vast majority of patients  before the ketamine would be given.The research could not be practicably carried out without the waiver; due to the acute clinical status of the trauma patient population , The waiver would not adversely affect the rights and welfare of the subjects; patients often receive opioids and/or ketamine in the Emergency Department acutely without their knowledge or written consent, they simply want pain control. We will be providing pain control and rescue opioids would not be withheld from the intervention group.We obtained a waiver of consent to randomize patients due to the following:Once the patient is randomized, a member of the trauma research team attempts to contact either the patient or legally authorized representative to obtain consent for using Protected Health Information, to return to perform discharge surveys, and to contact after discharge for post-discharge surveys. Consents are obtained by trained research personnel and patients are given written study information. If, after 5 days, the patient remains unable to self-consent and no LAR is available to consent, the consent is waived and data included. Additionally, if the subject does not survive following the traumatic injury or is discharged from the hospital before the study team is able to obtain consent, their information is included in data analysis.Trauma patients at the RDTI are initially prescribed with an opioid-minimizing MMPR informed by the MAST trial . This rePatients in the ketamine group receive sub-dissociative ketamine for a maximum of 72 h in addition to MMPR Table . KetaminThe treatment is initiated in the emergency department. In both treatment groups of this pragmatic trial, adjustments may include withholding or adjusting the dosage of MMPR medications due to comorbidities such as kidney or liver disease, withholding a medication due to interactions with other medications, and de-escalation of medications once adequate pain control is achieved. In both regimens, oral medications are also available as needed for breakthrough (moderate and severe) pain—oxycodone and/or tramadol. Although their use is discouraged in general clinical practice at our institution, intravenous opioids can be administered as needed.The primary outcome is opioid exposure defined as average MME per patient per day. MME/day was calculated by converting all sources of opioids during the hospital stay, including emergency department and operating room, to a single MME value using a standardized conversion chart and dividing by length of hospital stay Table . MME/daySecondary opioid exposure outcomes include total MME and opioid prescribing at discharge. Other secondary outcomes include pain scores, , Numeric Rating Score (NRS), and/or Defense and Veterans Pain Rating Scale (DVPRS), potential opioid-related complications , and ketamine-related information . Additional secondary outcomes include use of regional anesthesia, lengths of stay, and hospital costs. Patient requests to discontinue ketamine infusions and incidence of delirium are also being recorded.At 6-month follow-up, patients are contacted to assess for the presence of persistent post-traumatic pain and persistent opioid use. Additionally, at that time, patient-centered outcomes including quality of life will be assessed using Euro-QOL EQ-5D-3L .Due to the uncertainty of an exact treatment effect of ketamine in our patient population and the potential for contamination of the control group if the trial is continued for a prolonged length of time, we plan to perform the largest feasible study over 18 months. Over a sample period of 6 months (November 2018–April 2019), manual review of admission to the trauma service revealed 302 potentially eligible patients. Extrapolating this data, we expect 906 potentially eligible patients over the 18-month trial period. Given the emergent nature of the intervention, general difficulties enrolling severely injured patients, and several concomitant randomized clinical trials, we conservatively estimate enrolling 40% of potentially eligible patients.K = 1000 Monte Carlo simulations suggest there is a > 99% chance of observing this effect.We anticipate recruiting approximately 362 patients into the current trial. In an attempt to enhance participant enrolment and reach target sample size, all admitted patients are screened daily by research assistants for possible enrollment. Based on its skewed distribution, MMEs per day are postulated to be gamma distributed . Using the 50th and 75th percentiles, MME = 45 and 67 respectively, from our previous data, we estimate the control condition as following the distribution ~Gamma . Further, assuming that the ketamine condition results in a 20% decrease in MMEs (50th and 75th percentiles MME = 36 and 53.6 respectively), we assume the observed data for this condition is distributed ~Gamma . We assume that clustering within unit induces a substantial intra-cluster correlation (ICC) = 0.2. Finally, we stipulated that a 75% chance that the ketamine treatment reduces MMEs by at least 15% relative to treatment as usual would constitute sufficient evidence to warrant a larger clinical trial. Assuming the previously stated sample size, effect, ICC and decision rule, Randomization is performed at admission while in the emergency department in a 1:1 allocation and stratified by unit of admission. The random sequence was generated by an independent statistician. Allocation is performed by the in-house research assistant using REDCap database only accessible by investigators. This database is password protected and will not be shared with those outside of study .Providers and patients are not to be blinded to treatment allocation due to feasibility and cost. To address this issue, the opioid administration and pain score data  will be captured directly from the electronic medical record and the majority of outcomes will be obtained using our trauma registry (blinded outcome assessor).μ = 0, σ2 = 1000) on the identity or log-scale depending upon the model, level one error variances will be specified as ~Half-T . Prior distribution for level two variances will use ~Half-T . Priors for the comparison of proportions will be specified as ~Beta . For all subgroup analyses using multilevel models, the approach will follow that used in Tyson et al. [The data analytic strategy will use Bayesian inference, applying generalized linear multilevel modeling with level-two random effects or fixed effects (depending on model convergence) to account for clustering of participants within department and, where applicable, observations within participants. Modeling will use R v. 3.4 and Stan v. 1.10 , 16. Forn et al. .As this is a comparative effectiveness trial utilizing ketamine at a lower dose than commonly used in the Emergency Department for moderate sedation during procedures , no data and safety monitoring board will be formed. Major adverse events, including death, will be reported to the Institutional Review Board (IRB).Data is to be entered into RedCap for secure storage. REDCap is a mature, secure web application for building and managing databases. REDCap is compliant with standards such as HIPAA, 21 CFR Part 11, and FISMA . At UTHealth, REDCap is housed on two separate servers with both the database server and the web server located securely behind a firewall to improve confidentiality. Each item on the REDCap web forms will have validity checks performed to ensure that the data entered are accurate and that items are not skipped during entry by mistake. Depending on the question, any item found that does not meet the respective edit criteria will have an appropriate error message displayed when the user tries to save the data. Errors will be classified as either “hard” errors meaning that a valid response is required before the data can be saved or as “soft” errors in which the entry operator can either correct the errors or override them to indicate that the data are correct although it does not meet the edit criteria. Examples of hard errors would be items such as identifiers and event dates. An example of a soft error would be values that are outside a pre-defined range. Research personnel will have access to data for the purposes of data entry and data auditing. Investigators will have access to the data for purposes of data auditing and exporting. Once a record has been saved as complete, no one will be allowed to make changes to the records.The IRB of McGovern Medical School approved the study protocol on September 30, 2019. Enrollment was delayed by the COVID-19 pandemic but began on July 9, 2020, and is scheduled to continue for 18 months. As of April 23, 2021, 193 patients have been enrolled.Given that the current opioid epidemic was largely driven by legitimate opioid prescriptions after healthcare encounters, current acute pain management strategies must be thoughtful, responsible, and effective . EmblemaThe true rate of persistent opioid use following hospitalization for a traumatic injury is currently unknown, but trauma patients have often been considered at higher risk than general surgical patients. This higher risk has been attributed, in part, to opioid exposure during acute hospitalization and a larger proportion of patients who are considered “high risk” for persistent opioid use by the Opioid Risk Tool . In elecOur work in trauma patients has shown that reducing in-hospital opioid exposure leads to reduced prescriptions at discharge. In 2013, the median MME/day utilized at our institution prior to transition to MMPR was 65  and 81% of patients were discharged with an opioid prescription. In 2019, after universal implementation of generic MMPR, the median MME/day was 34 , and 62% of patients were discharged with an opioid.The KAPT trial is innovative in two main ways. First, it focuses on the first 72 h after admission, which we have shown is the time of highest opioid exposure after injury . While aSecond, the KAPT trial will be contacting patients after discharge to obtain 6-month follow-up information. Data regarding long-term pain and opioid use after injury is limited. We plan to determine the rate of persistent opioid use and persistent pain at 6 months following discharge.One limitation of this study is that prehospital ketamine administration is not recorded. Since we are striving for adequate randomization, prehospital use should be equal among both groups and thus the impact of this should be minimal. An additional limitation is lack of blinding to treatment groups but this was necessary due to logistical restrictions.In summary, the KAPT trial utilizes knowledge obtained from our previous work with opioid-minimizing regimens for traumatic pain and attempts advance our ability to decrease in-hospital opioid exposure and reduce opioid prescribing practices at discharge. In addition, this trial will enhance our understanding of long-term persistent opioid use, persistence of acute pain, and quality of life after injury. We hope to illustrate the safety of this drug and enhance our own learning healthcare system by allowing utilization of this medication across all levels of patient care and incorporating ketamine into our standard MMR.


Background: The study aimed to compare the clinical efficacy, safety, and acceptability of buffered lidocaine  versus non-buffered lidocaine  during inferior alveolar nerve block.Materials and methods: Fifty patients who required bilateral extractions in a single arch were included in this study. One hundred extractions were carried out, and all of the patients had nerve blocks during the procedure. We also took note of the patient's pain level as measured on a visual analog scale, as well as the start of the action, duration of postoperative analgesia, and occurrence of any problems. The duration of anesthesia was assessed by the feeling of numbness and the first sign of pain.Result: All the patients in both study groups reported subjective numbness of the lips and tongue. The depth of anesthesia was evaluated by pain and comfort during the procedure with a visual analog scale and showed no significant difference between the two groups. The onset of action for the pterygomandibular nerve block was 1.240.31 minutes (buffered) and 1.710.51 minutes (non-buffered). When compared, the duration of anesthesia was 327.18102.98 minutes (buffered) and 129.0826.85 minutes (non-buffered).Conclusion: This study concludes that the buffered solution has a faster onset of action than the non-buffered solution. Both solutions exhibit similar intraoperative efficacy. The duration of postoperative anesthesia was prolonged with buffering. Buffering also reduced pain scores during the early postoperative period. The use of local anesthetics in dental surgery was the standard practice even at the start of the 20th century. The inferior alveolar nerve block is often used for numbing the patient prior to mandibular reconstruction surgery. Nonetheless, pulpal numbness is not usually the consequence of blocking the inferior alveolar nerve. The success rate of inferior alveolar nerve blocks ranges from around 7% to 75%, as revealed by several experimental trials -3. A basThe genesis and conduction of nerve impulses as well as their propagation along the nerve are slowed by local anesthetics because they reduce the permeability of the neuron membrane to sodium ions . Given tAdding the vasopressor epinephrine to a local anesthetic like lidocaine or a sedative like fentanyl slows the onset of the anesthetic's effects by reducing blood flow to the area and spreading the drug beyond the injection site. To prolong the vasopressor's useful life, a sedative arrangement must be prepared at a pH of around 3.5, which is low, resulting in an acidic medium that may cause irritation and discomfort at the site of infusion in certain patients. The cartridge contains a balanced mixture of RN  and RNH+ ("charged" or ionized cationic structure that does not dissolve in lipids), with the former being able to traverse the nerve film while the latter cannot.Using the Henderson-Hasselbalch condition, we know that the total amount of constantly ionized local anesthetic in a dental cartridge is always dependent on the pH of the setup. At a pH of 3.5, for example, 99.99% of the lidocaine hydrochloride will be in the ionized structure (RNH+), which is insoluble in lipid solvents, and just 0.004% will be in the deionized form, which is soluble in lipid solvents (RN). As was previously mentioned, the ionized, nonpolar structure of a lipid solvent is the only one capable of penetrating the nerve layer. Once within the nerve, the RN picks up H+, and the subsequent RNH+ enters a sodium ion (Na+) channel to stymie nerve conduction. Until the body brings the pH of the cocktail into a more physiological range, the sedative will not take action (between 7.35 and 7.45) .When there is contamination, the local pH drops, making it difficult for the standard sedative fluid to deliver effective and long-lasting pulpal drowsiness. Contaminated tissue is more acidic, increasing the difficulty of the RN change . Most clEvidence for buffering's efficacy is growing; however, it is still infrequently employed in dental infusions. This is because vasoconstrictors, such as epinephrine, are unstable under increased pH, and the most popular approach of buffering adjacent sedatives must be carried out immediately before the infusion to produce the optimum benefits and ensure the safety of the vasoconstrictor. The current review intends to compare the efficacy of supported versus non-cushioned nearby sedatives during second-rate alveolar nerve block because only very limited studies have been carried out in inferior alveolar nerve block clinic settings, with the use of sodium bicarbonate-cradled sedative arrangements.Fifty patients reporting to the Department of Oral and Maxillofacial Surgery, seeking extraction of mandibular molar teeth bilaterally and satisfying the inclusion criteria, were taken up for the study. Informed consent was taken, and the Institutional Review Board of Rungta Dental College, Bhilai, India, gave approval (RCDSR/IEC/MDS/2016/8).Data CollectionA total of 100 cases were taken up for the study between the age groups of 18 and 60 years. Proper case history and hematological and radiographic examination were performed for each patient before the procedure. Patients aged 18-60 years who gave their informed written consent were included in the study. Patients included were advised to have bilateral multiple mandibular posterior teeth extracted. Women who were either pregnant or breastfeeding and patients with severe allergies to local anesthetics, a history of severe medical conditions, a weakened immune system, mental illness, or a physical disability were excluded from the study. The researchers intended to conduct a split-mouth clinical trial. Two groups, each having 50 patients, were formed: Group A, which did not receive a buffer, received 2% lidocaine and 1:180,000 adrenaline, and Group B used a buffer that included 2% lidocaine, 1:80,000 adrenaline, and 8.4% sodium bicarbonate. An individual was responsible for administering the local anesthetic. The equipment was fine-tuned and reinforced by an expert in oral and maxillofacial surgery. All of the participants were randomly placed into either Group A or Group B.Buffered Local Anesthetic Agent Preparation A 1.8 ml injection solution of 2% lidocaine with 1:80,000 epinephrine was diluted with 0.18 ml of the 8.4% sodium bicarbonate solution.Surgical TechniqueAfter a thorough case history and clinical or radiographic evaluation, a patient was enrolled in the research. Any patient who agreed to take part in the study was randomly placed in one of two groups. Prior to the treatment, patients were instructed to gargle with chlorhexidine gluconate mouthwash for 10 minutes. SODAC (8.4% sodium bicarbonate) from Neon Laboratories Ltd.  and 2% lidocaine diluted with adrenaline at a 1:80,000 ratio were utilized. The inferior alveolar nerve block used 1.5 ml of the solution placed using the traditional method, whereas the lingual nerve block used 0.3 ml. Additional anesthetic solutions were available for reinjection if required during the procedure. The clinical parameters were recorded, and extraction was performed. Once the tooth was removed, the socket was irrigated with normal saline. Hemostasis was achieved. Post-extraction instructions were given, and the patient was recalled for follow-up. The standard treatment for all patients consisted of 500 mg of amoxicillin every eight hours for five days postoperative to reduce the chances of secondary infection, along with 400 mg of ibuprofen every eight hours for discomfort. In the event of an allergy to amoxicillin, erythromycin 500 mg was administered eight times per day over the course of five days.A 100-mm visual analog scale (VAS) was used to quantify patients' reports of subjective pain, with zero indicating no discomfort and 100 indicating the worst agony imaginable. The amount of anesthetic given in milliliters was checked. When an anesthetic has taken effect, the patient will no longer feel pain in their lower lip, tongue, or mucosa (in minutes). The surgeon used a three-point scale to rate how well the local anesthetic kept the patient from feeling pain during the extraction: A. A majority of patients in Group B, including women, felt no pain throughout the surgery.B. Only a minority of patients in Group B felt pain throughout the process.C. The patients who felt pain during the process were administered further anesthetic agents.After anesthesia was given, the time taken to complete the extraction was noted. The time at which the first analgesic drug was administered after surgery was used to calculate the total period of pain relief (in minutes). The insensitivity of the mucosa, tongue, and lower lip after surgery was a visual representation of how long the soft tissues were under anesthesia. All sensations in the soft tissues were timestamped at the instant they reverted to normal. The treating physician or patient recorded the occurrence, categorization, and degree of problems .t-test statistics were used to examine the data, make conclusions, and offer descriptive analysis. IBM SPSS Statistics for Windows, Version 22.0  and GraphPad Prism 6.0, Released August 2012  were used for the statistical analysis. In most cases, the level of statistical significance is determined by the presence or absence of a p-value of 0.05.The data were analyzed using inferential and descriptive statistical methods. Descriptive statistics were used for just that: giving a bird's-eye perspective of a dataset. Chi-square and Student's unpaired p > 0.99 for both genders).The average age of Group A participants was 42.70 ± 12.56 years and that of Group B participants was 42.04 ± 12.76 years. This study was conducted with an equal number of male and female volunteers of all ages  during injection was 3.54, whereas the pain reported by the buffered group was only 0.96 , whereas those in the supported group used an average of 1.66 ml of narcotic preparation (18% sodium bicarbonate in 2% lidocaine). The Student's t-test was conducted and found that there is a statistically significant difference (p = 0.0001) between the two groups regarding the total amount of narcotic medicine used by their patients   begins functioning more quickly because of the sodium bicarbonate  (1) Table .p = 0.0001)  Table .t-test, a statistically significant difference was found in the mean pain on VAS in the two groups (p = 0.0001) .At one hour, 100% of the patients in the non-buffered group had no pain; 20% of the patients at three hours had no pain, 40% had mild pain, 28% had moderate pain, and 12% had severe pain; 2% of the patients at eight hours had no pain, 18% had mild pain, 26% had moderate pain, and 54% had severe pain. A statistically significant difference in pain on VAS was found in the non-buffered group at one hour, three hours, and eight hours using the chi-square test . Using the chi-square test, a statistically significant difference in pain on VAS was found in the two groups at three hours  and eight hours   5 a bottle and is widely available. Before injection, just combine the two in a syringe or container. The volume of liquid that can be stored in a 10 ml syringe is 11 ml, whereas a 20 ml syringe can contain 22 ml. In order to get the desired 1:10 ratio, a 10 ml syringe is filled to 11 ml with 1 ml of bicarbonate and 10 ml of 1% lidocaine with 1:100,000 epinephrine ,13.The onset timings of the various anesthetic preparations were not significantly different. Researchers observed that anesthetic formulations with higher pH values had a quicker onset time. This was the case in studies by DiFazio et al. , Zahl etIn this study, buffered lignocaine caused less injection discomfort than standard lignocaine. The action started faster and was more immersive. Both remedies had varying durations of impact. Injecting a buffered local anesthetic with lidocaine and epinephrine decreases injection site discomfort while having the same anesthetic activity and duration as a more concentrated unbuffered solution. Due to reduced injection discomfort, these preparations may be used for five-hour surgeries. Buffered lignocaine reduces injection and procedure discomfort, making dental and oral surgical operations under local anesthesia more comfortable for patients. However, multicentric research with larger sample sizes could increase buffered lignocaine's shelf life and production cost, making it a valuable tool in oral and maxillofacial surgery.


In rare instances, the extremely painful disorder trigeminal neuralgia (TN) may develop as a result of multiple sclerosis (MS). In this article, we will be discussing the case of a 56-year-old female with TN. Antidepressants and analgesics can lessen the pain, although they were not very effective, and higher doses led to greater drowsiness and a poorer quality of life. Radiofrequency ablation helped this patient significantly lower the pain and led to an improved lifestyle. This case presents right-side radiofrequency ablation of Gasserian ganglion in a patient with unilateral TN with MS.  A neuropathic pain disorder affecting the trigeminal distribution of the face is termed trigeminal neuralgia (TN). Multiple sclerosis (MS) patients experience various neuropathic pain, with TN being the most severe. As per the International Association for the Study of Pain, TN is a sudden, typically unilateral, recurring pain that impacts one or more branches of the trigeminal nerve. TN pain might throb for anywhere between a few seconds or minutes, but when it is severe, it may persist for an hour. Starting in the pons, divisions of the trigeminal nerve are the ophthalmic V1), maxillary (V2), and mandibular (V3) branches. The patient's physical capabilities and quality of life may be adversely impacted in TN. In a 2:1 ratio, women are more impacted than men. The nerve's maxillary and mandibular divisions are the most often impacted divisions , maxilla. SeveralThe main complaint of a 56-year-old female patient with known MS who visited our hospital was episodic discomfort across the right side of her face over the previous 12 months. Eating, swallowing, gritting her teeth, and cleaning her face all caused discomfort that was increased by light cutaneous or sensory stimulation. Her visual analog scale (VAS) rating for her neuropathic pain was a 9/10. She had been taking 300 mg carbamazepine tablet TDS daily and 20 mg baclofen tablet at night daily with 150mg pregabalin tablet at night for the previous two months. The patient complained of extreme drowsiness as a result of the higher medicine dosages.The patient was medium built with a body mass index of 23, well-nourished, cooperative, and well-oriented to time, place, and person. The results of the systemic evaluation were normal. Upon closer inspection, it was found that the mandibular nerve region was heavily involved and that there was severe pain over its distribution. On ENT and dental opinion, which did not conclude any other diagnosis, we came to the diagnosis of TN in this patient with a known case of MS. We prepared for the right-sided radiofrequency ablation of the Gasserian ganglion because the intensity of pain was high with harrowing in daily activity and also the patient refused medicinal therapy. Under all aseptic precautions and fluoroscopic guidance and local anesthesia, a 22G 10 cm cannula with an active tip of 5 mm was inserted. The cannula position was confirmed by a fluoroscope and by stimulation. A right-sided fluoroscopic-guided radiofrequency ablation was done at temperatures of 60° C, 65° C, and 70° C each for 90 seconds while the patient was lying on her back. With no difficulties, this led to decreased pain in the distribution of mandibular division. After six hours, the discomfort was effectively relieved. Only carbamazepine tablet, 200 mg twice daily, was given to the patient before discharge. The patient was doing well with day-to-day activities and had a VAS of 1/10 at the follow-up appointment after one month  . Nerve fIn cases of MS, TN is one of the most common and challenging neuropathic painful conditions to treat. Daily routines, employment, mood, leisure time, and general quality of life can all be affected by TN in MS patients. According to research, a pontine demyelinating plaque is related to TN subsequent to MS. Although there are data to support the hypothesis that TN caused by MS may occasionally occur with neurovascular compression, there are presently no high-quality studies examining the effectiveness of microvascular decompression in individuals with MS -18. The In patients with TN, we can either give ganglionic block or do radiofrequency ablations. In Meckles Cave, the Gasserian Ganglion can be partly ablated using glycerol or by creating a radiofrequency lesion. Administering a Gasserian ganglion block requires technical proficiency and fluoroscopy assistance . GasseriThe most severe neuropathic pain that patients with MS might suffer is called trigeminal neuralgia. TN is one of the most challenging neuropathic conditions to treat. It can severely affect patients' lifestyles and can leave some patients with neuropathic agony. Radiofrequency ablation of Gasserian ganglion is performed when medicinal treatment is ineffective or in cases having side effects with medical management or if the patient is refusing to continue medical therapy. Radiofrequency ablation produces effective analgesia and decreases the doses of drugs needed for analgesia in the patient. Depending upon the division of the trigeminal nerve being ablated, different optimal temperatures are required for the radiofrequency ablation procedure. TN is a severely painful condition with no curative treatment available. For the management of pain, more study and advancement in neuropathic diseases and therapeutic techniques are crucial.


Changes in lifestyle, a carbohydrate-rich diet, and decreased physical activity are part of the context that led to an obesity pandemic. Treating obesity is a task that requires multidisciplinary care; however, in many cases, conventional therapy has no effect, requiring surgical intervention. This, in turn, is not without risks and causes important changes in lung function. Therefore, the aim of this study is to evaluate the effect of electroanalgesia through conventional transcutaneous electrical nerve stimulation (TENS) on the pain and lung function in the postoperative period of bariatric surgery. n = 33) and a placebo group (n = 33). The participants underwent 4 TENS sessions, and the effect on pain was assessed using a visual analogue scale (VAS pain). Lung function was measured by spirometry.  This is a controlled and blinded clinical trial with 66 subjects who underwent bariatric surgery. The participants were randomized into 2 groups as follows: an intervention group treated with TENS (p = 0.001). Regarding the effect of electroanalgesia on pulmonary function, the spirometric parameters were similar between the groups. However, regarding muscle strength between the preoperative and postoperative periods, maximal inspiratory pressure (MIP) was maintained in the intervention group and decreased in the placebo group (p = 0.03). Compared with that in the intervention group, the respiratory rate in the placebo group increased during the application of TENS (p = 0.003).  There were no differences between the 2 groups regarding time of surgery and time of mechanical ventilation. Compared to placebo, TENS reduced pain in the intervention group (NCT04800640. Electroanalgesia reduces pain in patients who underwent bariatric surgery. Importantly, in these patients, the MIP is maintained between the preoperative and postoperative periods. However, electroanalgesia does not contribute to improvements in spirometric data. This trial is registered with  Obesity is one of the main public health problems worldwide, with a multifactorial aetiology resulting from changes in eating habits, social factors, psychological changes, and epigenetic changes . It has When undergoing upper abdominal surgery, obese individuals are more susceptible to pulmonary repercussions caused by anaesthesia and by the surgical procedure itself. In obese individuals, anaesthesia accentuates the reduction in functional residual capacity (FRC), promoting the closure of small airways. This leads to a higher degree of hypoxemia than that observed in nonobese patients, in addition to a higher incidence of atelectasis . In the α2A-noradrenergic receptors, decrease in excitatory neurotransmitter (substance P), and activation of peripheral inhibitory μ-opioid receptors   vs. -5.5 (-46–0),  = 0.03] . The datp < 0.001)  . AdditioTo provide context for interpreting the null findings, a post hoc power analysis was performed using GPower 3.1.1 software. Considering a type-I error of 5% and type-II error of 10% (study power of 90%), a minimum sample of 46 participants (23 per group) is necessary to observe a mean difference of at least 2 (SD of 2) in pain intensity between groups after the 4-session intervention.The main findings of the present study were that the use of electroanalgesia reduced pain levels in patients. Compared with placebo, TENS did not result in improvements in spirometric parameters. However, there was a positive effect of TENS on the maintenance of inspiratory muscle strength. In addition, the nonapplication of TENS  resulted in an increase in the respiratory rate. To our knowledge, this is the first study that investigates the use of TENS and evaluates its effect on pain and pulmonary function and haemodynamic parameters in patients in the postoperative period of open bariatric surgery.A receptors could be related to decreased production of glutamate and other excitatory amino acids, resulting in decreased pain; this demonstrates that the application of TENS to the patient's skin results not only in local and spinal cord but also supraspinal action [β fiber to a set of interneurons; these, in turn, inhibit retransmission at the medullary level of painful stimuli conducted by A-delta and type C fibers [In addition to obesity-related pulmonary functional changes, bariatric surgery amplifies restrictive ventilatory damage, either by tissue injury caused by the surgical incision or by the effects of anaesthesia, operative time, mechanical ventilation time, or pain. To relieve postoperative pain, one physiotherapeutic resource is the use of electrical currents to reduce pain stimuli and produce a morphine-like effect. Borges et al. evaluated the effect of TENS in patients in the postoperative period of abdominal surgery and found a reduction in postoperative pain in patients who received active TENS compared with those who received placebo and those in the control . In our l action , 24, 27.The physiological effects of electrotherapy on the neurological and musculoskeletal systems are capable of reducing pain, which explains, at least in part, our results. Notably, other positive effects of TENS in patients in the postoperative period include muscle stimulation, vasodilation, reductions in oedema, reductions in reflex inhibition, facilitation of soft tissue injury healing, and facilitation of fracture consolidation .Similar to our study, other authors have also evaluated the effect of TENS in the postoperative period of different surgeries. Tokuda et al. evaluated 48 patients in the postoperative period of abdominal surgery, comparing an intervention group (TENS) with a placebo group . These aThe effects of pain result in a worsening of thoracic dynamics and consequently a reduction in the mobility of respiratory muscles, generating a reduction in inspiratory and expiratory pressures . This haWith a reduction in pain, patients should exhibit improvements in haemodynamic parameters, including respiratory rate, blood pressure, and heart rate. In our study, the respiratory rate in patients in the placebo group increased, suggesting a positive haemodynamic effect of TENS, i.e., maintaining the respiratory rate at a normal level. As shown by Fiorelli et al., significant incisional pain reduces chest mobility, causing depressed respiratory function, thus resulting in an inability to breathe deeply and cough effectively . This siAs with any study, ours also has its limitations. First, the sample was relatively small, and the study included only 1 centre, which makes it difficult to generalize our results. Second, although the 2 groups were matched for anthropometric measurements, the group that received TENS had a mean age slightly lower than that of the placebo group. Despite these limitations, this study serves as a starting point for other randomized controlled trials with a greater number of patients undergoing other types of weight reduction surgery, such as laparoscopic surgery, vertical gastrectomy, and duodenal switch.Our results indicate that the use of electroanalgesia reduces pain levels in patients. Although there was no change in spirometric parameters, there was a protective effect of TENS on respiratory muscle strength, with the maintenance of MIP values within the normal range. In addition, there may be an effect of TENS on haemodynamics because of its nonuse (placebo) affected tachypnoea. Based on the results of this study, electroanalgesia is a valuable tool in pain relief and the maintenance of respiratory muscle strength in the postoperative period of open bariatric surgery.