We do not yet know whether or the extent to which multimodal therapy changes the health behaviors and health service use of chronic headache patients in the long term. Associations are expected between pain symptoms and pain management abilities for patients who are categorized as successfully treated and those who remain unchanged.Routine longitudinal data of an enrolment period of five years from 101 headache patients treated with a two-week, full-day, semi-inpatient multimodal pain therapy at the Interdisciplinary Pain Center of the University Clinic Erlangen were available when therapy began and 12 months after treatment. To investigate long-term changes in health behavior and health service use as well as their associations with the outcome “reduction in pain days,” we used descriptive and inferential statistics .p < .001) as well as increases in the use of relaxation techniques (p < .001), TENS devices for relaxation purposes (p = .008), psychological coping strategies (p < .001), and mindfulness-based techniques for dealing with pain (p < .001). 52.8% of the sample reported a reduction in the number of pain days 12 months after treatment. Binary logistic regression (χ2 (12) = 21.419; p = .045; R2 = .255) revealed that a reduction in pain days 12 months after treatment was positively associated with regular physical activity in the form of muscle strengthening and stretching (athletic sports) (p = .012).Patients who underwent interdisciplinary treatment showed statistically significant changes in their health behavior in five areas. Twelve months after treatment, we found a significantly higher frequency of engagement in athletic sports (Chronic headache patients acquired long-term skills from an interdisciplinary treatment concerning the use of relaxation techniques, the use of psychological coping strategies, and physical activity in the form of athletic exercise. Of those, regular athletic exercise was positively associated with a smaller number of pain days in the long term. Thus, a physical activity module should be an element of interdisciplinary treatment for chronic headache patients.The online version contains supplementary material available at 10.1186/s12883-022-02646-w. Pain is defined as “an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage” in an updated definition by the International Association for the Study of Pain (IASP) , 2. ChroThere are different therapeutic approaches for treating headaches. First line treatment is pharmacotherapy based on principal national and international guidelines and consists of acute and preventive medications –17. For To explore the status and changes in the health behavior and health service use of the patients one year after treatment.To investigate which health behaviors/skills taught in interdisciplinary therapy and which uses of outpatient medical and non-medical care are associated with the successful treatment of headache symptoms.The question is whether such interdisciplinary treatments, with proven effectiveness –22, can Did the health behavior and the use of health services in the sample of headache patients who received interdisciplinary treatment change significantly from the beginning of treatment to one year after treatment?Are certain health behaviors or patterns in the use of health services in the year after treatment associated with a successful treatment based on a reduction in the number of days patients experienced headaches one year after interdisciplinary therapy? And if so, which of them?The above mentioned aims led to the following research questions:Routine longitudinal data collected from chronic headache patients treated with semi-inpatient interdisciplinary group therapy in 2015 – 2020 at the Interdisciplinary Pain Center of the University Clinic Erlangen were assessed. The patients took part in a multimodal headache-specific interdisciplinary pain therapy that has been evaluated before . ParticiData were collected from 14 groups during the evaluation period. 106 patients were available when therapy began, of which 101 provided follow-up information. Single missing values in the outcome variable (< 3%) were imputed with the EM algorithm. There were three cases with a missing value in one predictor variable, for which the missing values were also imputed.The mean age of the analyzed sample was 38.1 (SD 12.6) years, and the majority were women (92.1%). Less than half were married (39.8%), and a small number were divorced (6.1%). However, only about one fourth of the sample was living alone in their household (22.9%), and the rest had cohabitants. Most of the patients did not have a migration background (89.1%). 44.9% of the participants had 10 years of education or less, whereas 37.8% had a university degree. About three quarters (74.5%) had vocational education and training. The majority of the sample was still active in the workforce or in the education track – 83.5% had contracts for paid activity. Only 17.1% had an actual certificate of illness, and 7.3% were on permanent sick leave. A minority had an accepted degree of disability (12.2%). A large proportion of the participating headache patients had been suffering from pain for at least 5 years (75.8%), 14.1% had suffered from chronic headache problems for 2 to 5 years, and only 3.0% stated that they had been suffering for less than 1 year. A total of 11.2% claimed to have permanent pain with slight deviations, 14.3% claimed to have permanent pain with large deviations, 26.5% described pain attacks with pain between the attacks as well, and the majority of the sample reported regular and frequent pain attacks but without pain between the attacks (48.0%). Patients with pain attacks usually had them several times a week (59.5%) or several times a month (29.7%). For more than half of the patients who suffered from attacks, the attacks lasted up to three days (54.1%), and for a minority (10.8%), they lasted even longer. One third of the patients who suffered from attacks had average attack durations of several hours (33.8%). At the start of therapy, patients self-classified their headaches as the following: 81.2% migraine, 69.3% tension-type headache, 7.9% other type of headache (multiple responses possible).https://ichd-3.org/de) ). At follow-up 49.1% of the patients (n = 52) were taken pain prophylaxis medication. The percentage was basically stable in comparison to therapy start (p = 1.000).The average severity of pain at follow-up was M = 5.6 SD 2.1) for (self-classified) migraines and M = 4.1 (SD 1.6) for (self-classified) tension-type headaches. For both subgroups a statistically significant reduction of pain severity was observable for self-classified migraine  resulted (χ2 (12) = 21.419; p = 0.045), interpretable as a small effect [p = 0.012; OR: 1.96). Thus, every additional unit of athletic sports per week doubled the chance of reducing the number of pain days. The use of psychotherapy in the last 12 months was negatively associated with a reduction in pain days . Thus, patients with major mental comorbidities needing additional outpatient treatment for such conditions have a smaller chance of reducing their number of pain days 12 months after treatment. In other words, in our study, patients seeking psychotherapy had a 257% higher chance of having an unchanged (non-reduced) pain symptom load in comparison with patients who did not have additional psychotherapeutic treatment (Table A binary logistic regression with the dichotomous outcome reduction in pain days at follow-up (yes = 1/no = 0) and 12 predictors from the areas of health behavior, medical service use, use of alternative medicine, and adjuvant therapy was carried out. A significant model with an acceptable explained variance of 25.5% (Rl effect . Existin2 (12) = 9.861; p = 0.628), presumably due to the smaller number of participants fulfilling the criterion and thus less variability. However, the significant predictor “existing regular physical activity in the form of athletic sports” reported above was also  associated with the outcome of at least a 50% reduction in pain days (p = 0.062).As a second sensitivity analysis, the binary logistic regression was alternatively carried out with the more conservative outcome “at least a 50% reduction in pain days” (yes/no). A significant model did not result  and to the use of different techniques for relaxation. Besides these skills, psychological strategies and techniques for dealing with the pain that still existed were learned and used.A limitation of this study is the lack of a control group so that we do not know the extent to which chronic headache patients would have acquired these skills without interdisciplinary treatment. However, the literature shows that interdisciplinary  pain therapy leads to changes in health behavior in the long term , 21, andBesides the change in health-related behavior from acquiring skills, interdisciplinary treatment for chronic headache patients has been shown to be effective in lowering the burden of illness in terms of pain days or headache-related disability , 35–37. Again, the extent to which the number of pain days would have decreased without interdisciplinary treatment is unknown because of the lack of a control group. However, the literature confirms the effectiveness of the interdisciplinary treatment of headache patients in terms of decreasing the number of pain days , 36, 37.Regarding exercise training, there is evidence that especially high-intensity interval training is somewhat superior to moderate continuous exercise programs for migraine patients , howeverThe cohort of headache patients explored in our study was comparable in age with other studies for example those included in a recent meta-analysis  or in anp-values were corrected for multiple comparisons, there was a trend  that the use of questionable evidence-based treatments  decreased after headache patients participated in an interdisciplinary treatment. As expected, the frequency of pain-associated GP visits or visits to medical specialists remained unchanged. This result was expected and reflected the organized transition from semi-inpatient to outpatient medical care. The smooth transition cannot be taken for granted as researchers have described the problem of continuity of health care for headache patients [The frequency of the use of “alternative medicine,” such as acupuncture or CAM treatments, was comparable to an Austrian study before patients were enrolled in interdisciplinary treatment. There, about ¼ of the headache patients reported using acupuncture (28.1%) and homeopathy (24.6%) before therapy began in an interdisciplinary treatment center . Comparapatients . The boupatients  showed tOur results suggest that the additional use of psychotherapy was negatively associated with a reduction in the number of pain days at follow-up. This finding should not be interpreted to mean that psychotherapeutic treatment causes impairments, but it rather underlines the larger burden of illness in highly comorbid patients. Mental comorbidities in chronic pain patients are common , 48 and The study was carried out as an evaluation of routine data from a treated cohort of chronic headache patients. Therefore, all of the individuals who were analyzed received interdisciplinary treatment, and a comparison with untreated individuals was not possible. Thus, the data do not allow classic interpretations of the efficacy of interdisciplinary treatment. Estimations of the amount of change in health behavior and health service use in chronic headache patients without interdisciplinary treatment is not possible.Second, the sample was small even though data of an enrolment period of five years were included. The small sample size might have led to a lack of power to detect changes between the two time points. For example, there have been statistical trends in the change in the use of treatments involving acupuncture or complementary/alternative medicine that would have been statistically significant in a larger sample with a larger number of participants who used such treatments. Consequently, existing clinically relevant changes appear and are interpreted as statistically non-significant. The small sample is also a disadvantage when analyzing different “success” outcomes. Setting more strict boundaries in defining outcomes implies that fewer patients are fulfilling the criteria, which again consequently results in a lack of power and a lack of variability in those fulfilling the success category. Thus, we will need to repeat such analyses with different outcomes  with a larger sample after more patients are enrolled in the future.Third, routine data were assessed from one interdisciplinary pain treatment center. Whether the results are generalizable to other centers can be discussed. However, the treatment concept is manualized and implemented in all German semi-inpatient/inpatient treatment centers, and the outcome assessment is standardized in those using the evaluation module from the German Pain Questionnaire . In a prFourth, comparison data for health care utilization are largely unavailable, especially regarding headache patients undergoing an interdisciplinary treatment. There has been one representative German study exploring the frequency of GP use in the general population with self-reported headache. Compared with that, the patients in our sample had more pain-related GP visits on a regular basis. However, Müller et al. assessed the general population reporting headaches, not chronic headache patients, which was the highly burdened sample undergoing interdisciplinary treatment we assessed . LikewisChronic headache patients who participated in an intensive multimodal interdisciplinary treatment on average acquired skills that were available in the long term and implemented into their daily routines. Such skills concern the acquisition and use of relaxation techniques, the use of psychological strategies to deal with still existing chronic pain, and regular physical activity in terms of athletic exercise. Of those health behavior skills, a regular engagement in athletic sports was positively associated with a decrease in (headache) pain days in the long term. Thus, interdisciplinary treatment concepts should not be applied without a physical activity module.Additional file 1.


With increasing follow‐up of patients treated with minimally invasive ventral mesh rectopexy (VMR) more redo surgery can be expected for recurrent rectal prolapse, mesh erosion and pelvic pain. The aim of this study is to evaluate the 90‐day morbidity of robot‐assisted redo interventions.All robot‐assisted redo interventions after primary transabdominal repair of rectal prolapse between 2011 and 2019 were retrospectively analysed and compared with the results for patients after primary robot‐assisted VMR during the same period. The redo interventions were divided into groups based on the indication for surgery . Intraoperative complications and 90‐day postoperative morbidity were evaluated.p > 0.05). More intraoperative complications, minor and major complications were seen in redo surgery for erosion compared with primary VMR . The frequency of intraoperative complications after redo surgery for pelvic pain was 7% with minor and major morbidity rates of 14% and 7% (p > 0.05). Half of the patients with pelvic pain experienced relief of their symptoms.Three hundred and fifty nine patients were treated with primary VMR, with 73 for recurrent rectal prolapse, 12 for mesh erosion and 14 for pelvic pain. Complications of recurrent prolapse surgeries were comparable to those of primary VMR (Redo surgery for management of recurrent rectal prolapse is safe. Redo surgery for mesh erosion is associated with high morbidity rates. Redo surgery for pelvic pain can have major complications and is only effective in half of the cases. This paper provides new information regarding the safety and risks of redo surgery for recurrence, mesh erosion and pelvic pain. It will help clinicians and patients in treatment decision‐making and preoperative counselling in both primary ventral mesh rectopexy and redo surgery after previous rectal prolapse surgery.Since its introduction in the early 2000s minimally invasive laparoscopic ventral mesh rectopexy (VMR) has found wide acceptance in the treatment of rectal prolapse (RP) , 2. UnfoThe majority of redo surgery is performed in patients who develop a recurrent RP. The treatment strategy for recurrent prolapse is not uniform and a previous attempt to create a treatment algorithm was not successful . HoweverPatients with mesh erosion usually have symptoms of pain, dyspareunia, purulent or serosanguinous discharge and/or functional complaints , 14, 15.A third group consists of patients with therapy‐resistant pelvic pain, without evidence of mesh erosion, who request mesh removal. The incidence of pelvic pain is understudied and only recently a first retrospective study described de novo pelvic pain in 15% of patients . CurrentIn this study all robot‐assisted surgeries after previous surgery for RP in a tertiary referral centre were analysed. The aim was to evaluate the safety of redo interventions with regard to intraoperative complications and 90‐day morbidity in patients treated for recurrent RP, mesh erosion or pelvic pain.This study was conducted in a tertiary referral centre for pelvic floor pathology with a national referral function. The study protocol was approved by the institutional review board and requirement for informed consent was waived due to the retrospective study design. Part of the cohort has been described in previous studies with other research aims , 7.All patients undergoing a robot‐assisted intervention related to RP between March 2011 and December 2019 were included. All abdominal procedures for primary and redo interventions were performed with the Da Vinci robotic system . A redo intervention was defined as surgery to treat a complication after a previous abdominal intervention for RP and/or apical prolapse. This includes redo surgery for (1) recurrent RP, (2) mesh erosion and (3) pelvic pain.Primary outcome measurements were intraoperative complication rates and 90‐day morbidity rates. Outcomes were compared with primary robot‐assisted VMR (RVMR). Major complications were defined as Clavien–Dindo (CD) classification grade >2 . If patiPatients were assessed by a multidisciplinary team. Additional imaging and functional assessments were made on indication.The preoperative work‐up was similar to that of patients with primary complaints and has been described in detail previously . PatientPhysical examination of the rectum and/or vagina was performed in the case of complaints possibly related to mesh erosion. If the erosion was small and without signs of infection, transvaginal or transanal excision was considered. If this failed or did not seem appropriate , a robot redo intervention was planned to remove the mesh and close the defect. The possible need for a diverting stoma was discussed.In cases of chronic pelvic pain after previous VMR or other prolapse surgery with mesh implantation, other underlying causes of pain  were excluded. A redo intervention for mesh removal was performed with great reluctance and was considered if conservative pain management failed and patients requested mesh removal. Patients were counselled that surgery was not a guarantee of relief of complaints. Because of the risk of recurrence of prolapse symptoms after mesh removal, patients were additionally counselled for resection rectopexy.Techniques and materials for redo RVMR were similar to primary RVMR . PreviouRRR was performed according to previously described techniques . Old mesAll mesh was intentionally removed, and the defect was closed with transabdominal (±omentoplasty) and transvaginal and/or transrectal absorbable sutures.Depending on the location and extent of the defect, a diverting stoma was created in patients who were expected to have a high risk of development of a new rectovaginal fistula. In the case of pelvic pain all mesh and tackers were removed unless the risk of complications seemed higher than the possible gain.All patients were routinely seen at 6–12 weeks after surgery in the outpatient clinic.t‐test, the Mann–Whitney U‐test and the chi‐square or Fisher's exact test were used as appropriate. A p‐value <0.05 was considered significant. Analyses were performed using SPSS version 24 (IBM Corp.).Data are presented as mean ± standard deviation (SD) and median with interquartile range (IQR) for parametric and nonparametric continuous variables, respectively. Numbers and percentages are used for categorical variables. The independent samples A total of 462 robot‐assisted surgeries were performed: 359 were primary RVMR cases and 103 were redo interventions. Of the redo interventions, the indication for surgery was a recurrent prolapse in 76 cases (72%), mesh erosion or infection in 13 cases (12%) and pelvic pain in 14 cases (13%). Baseline characteristics of patients with primary RVMR and patients with a redo intervention per subgroup are shown in Table Seventy six robot redo surgeries were performed for recurrent RP in 72 patients. Four patients underwent a second robot redo intervention due to a re‐recurrence Figure . Redo RVA careful assessment of operation notes showed that failure of the previous VMR was thought to be related to suboptimal distal mesh positioning in 54 cases (71%), i.e. the mesh was not positioned deep enough in the rectovaginal septum, was positioned too laterally or failed to give adequate tension. In three cases (4%) the mesh was luxated from the sacral promontory. In seven cases (9%) reason for failure was unclear and 12 patients (16%) had a previous rectal suspension other than VMR . Complications and their treatment are depicted in Table After redo RVMR two patients developed a mesh erosion after the 90‐day postoperative course (after 22 and 82 months). These cases will be further elaborated on as part of the mesh erosion group.Twelve patients diagnosed with mesh erosion underwent a robot redo intervention . In one patient a second robot redo intervention was necessary after 9 months because of a rectovaginal fistula due to infection of residual mesh Figure . Only onp‐value 0.01; Table p‐value 0.06) and five patients (38%) suffered from a major complication . In four patients, major morbidity led to the creation of a loop ileostomy or colostomy (Table An intraoperative complication occurred in three patients 23%), compared with 12 patients (3%) in primary RVMR  pain was relieved to the patient's satisfaction, six patients (43%) still experienced pain and in one patient it was unclear what effect surgery had had on the preoperative complaints. The pain relief experienced was better in the group with complete mesh removal (five out of six patients with improved symptoms) compared with patients in whom mesh removal was incomplete (two out of eight patients with improved symptoms).Reasons for redo surgery after surgical repair for RP can be recurrence, mesh erosion or chronic pelvic pain resistant to conservative management. This study gives an overview of safety outcomes with regard to these three indications in patients undergoing robot‐assisted redo surgery.Symptomatic recurrence after VMR has been described in 5%–15% of cases and increases with longer follow‐up , 4, 5. TWe found that in 71% of cases failure of the primary VMR was due to suboptimal fixation of the distal side of the mesh. This is important information for surgeons performing primary VMR and shows the importance of well‐trained and dedicated surgeons. Only a small proportion showed proximal mesh detachment. The change in our clinic to absorbable sutures was made only recently and does not affect this cohort. Although this change in material might conflict with our observation of suboptimal distal mesh fixation as a reason for failure of VMR, we reckon that by the time the suture material is absorbed, ingrowth of native tissue into the mesh implant will give sufficient support and fixation to prevent luxation. Future studies comparing recurrence of VMR with mesh fixed with absorbable sutures versus nonabsorbable sutures are important to confirm this hypothesis.Laitakari et al.  recentlyMesh erosion rates after VMR have been described in 1%–2% of patients , 6, 8. IThere is no consensus regarding the treatment strategy for mesh erosion. This is reflected in the varying approaches described in previous studies. Management varies from transanal resection  , 15, 18,Ratnatunga et al.  publisheIn the multicentre study of Evans et al. , 3 of 45Although concerns about post‐VMR pelvic pain have increased, the prevalence of this complaint is understudied. Only recently a retrospective study was published describing de novo pelvic pain in 15% of patients after VMR . AlthougAn overall limitation was the retrospective study design and the small cohorts of patients with redo surgery for mesh erosion and pelvic pain. However, this is still the largest group of patients to be described in the literature thus far. This study included patients up to 90 days postoperatively. Future studies should focus on functional outcome and quality of life after longer follow‐up.In conclusion, redo surgery has been shown to be a safe procedure in the management of recurrent RP with comparable complication rates to primary VMR. In the management of mesh erosion, redo surgery is associated with a high major complication rate of 38%. Redo surgery for pelvic pain has a major complication rate of 7% and does not lead to relief of symptoms in a high percentage of patients. It should therefore be performed reluctantly. Based on these results, we strongly advise referral to a tertiary pelvic floor centre when redo surgery, and possibly even primary VMR, is being considered. In this way patients can be diagnosed and treated by an experienced and multidisciplinary team to minimize the risk of complications. This study is of great importance for clinicians and patients when considering both primary VMR and redo surgery for recurrence, mesh erosion or pelvic pain.PMV, ECJC and IAMJB are proctors for Intuitive Surgical. EMvdS has no conflicts of interest to declare that are relevant to the content of this article.All authors qualify for authorship and agree to the submission.This retrospective study involving human participants was in accordance with the ethical standards of the institutional and national research committees and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The institutional review board of Meander Medical Centre approved this study.Requirement for informed consent to participate was waived by the institutional review board due to the retrospective nature of the study.


The clonidine group required less morphine equivalent/kg on postoperative day 2  vs. 0.47  p = 0.002). There was no difference in median NRS pain scores. Both groups had similar catheter infusion durations, hospital length of stay, and complication rates. Conclusion: A postoperative pain management plan that includes paravertebral analgesia, including clonidine as an adjunct, may be considered to minimize opioid administration for patients undergoing primary Nuss repair.Introduction: The continuous paravertebral blockade as part of the multimodal pain protocol is an effective regional technique to control pain after the Nuss procedure. We investigated the effectiveness of clonidine as an adjunct to paravertebral ropivacaine infusion. Methods: We conducted a retrospective study of 63 patients who underwent Nuss procedures and received bilateral paravertebral catheters. Data on demographics, surgical, anesthesia, and block characteristics, numeric rating pain scores (NRS), opioids consumption, hospital length of stay, complications, and side effects from medication administration were collected in children who received paravertebral ropivacaine 0.2% infusion without (N = 45) and with clonidine (1 mcg/mL) (N = 18). Results: The two groups had similar demographics, although the clonidine group had higher Haller indices  vs. 4.8 ,  Pectus excavatum is the most common congenital chest wall deformity. It has an estimated incidence of one to eight in 1000 births . The mosThere remains to be more consensus on managing postoperative pain in this surgical population. Multiple modalities, including thoracic epidurals, paravertebral nerve blocks, wound catheters, multimodal management, intrathecal morphine, erector spinae catheter blocks, and cryotherapy, have been reported at different institutions ,7,8,9,10This retrospective study was conducted at UPMC Children’s Hospital of Pittsburgh from September 2014 to July 2018. It was approved by the University of Pittsburgh Institutional Review Board that waived requirements for informed consent. Patients who underwent a Nuss procedure for pectus repair and received bilateral paravertebral catheter and a multimodal approach for postoperative pain management were included in the study. The following patients were excluded: (1) patients who underwent the Ravitch procedure, (2) repeat revision of a prior Nuss repair, (3) patients older than age 18 years, and (4) patients with a chronic pain history and/or requiring opioid pain medications for more than a month before surgery.Data were collected from the patients’ electronic medical records. The primary objectives of the study were to compare: (1) daily numerical rating scale (NRS) pain scores, (2) total daily opioid consumption in morphine equivalents, and (3) length of catheter infusion duration and hospital stay in days. The secondary objective was to compare complications associated with nerve block placement and/or side effects of medication.All surgeries were performed by experienced surgeons using a standardized surgical procedure. Before surgery, the bilateral ultrasound-guided thoracic paravertebral nerve catheters were placed at the T4-T7 level under sedation or general anesthesia, as described by Borestky and et al. . A bolusOn POD 0, as soon as the patient arrived in the patient anesthesia care unit (PACU), local anesthetic infusions through the bilateral paravertebral nerve catheters were initiated with 0.2% ropivacaine at a rate of 8 mL/h on each side, with 2 mL clinician boluses administered by the nurse every 180 min on each side as needed for each side. Each patient was given hydromorphone via PCA, which included a demand dose of 5 mcg/kg every 10 min, a clinician bolus of 7 mcg/kg every 30 min, and a continuous infusion at 1 to 2 mcg/kg/h. The ketamine infusion was started at 0.1 mg/kg/h. Other medications administered were intravenous (IV) acetaminophen 15 mg/kg every 6 h (maximum 4000 mg/day), oral (PO) gabapentin 300 mg every night (unless the patient was sedated), IV diazepam 0.05 mg/kg every 6 h as needed for muscle spasms, and IV ondansetron 4 mg every 6 h. Ketorolac was administered if the surgeon agreed.On POD 1, the paravertebral nerve catheter infusions were adjusted as necessary to improve pain control. The hydromorphone PCA was continued without the continuous infusion, while adjustments were made to the demand dose and clinician bolus. The ketamine infusion, IV acetaminophen, PO gabapentin, and IV diazepam were continued. Cyclobenzaprine 5 to 10 mg twice daily was added to ketorolac 0.5 mg/kg (maximum dose 15 mg) every 6 h .On POD 2, the paravertebral nerve catheters were continued. The hydromorphone PCA was discontinued. Oxycodone 0.1 mg/kg, maximum 5 mg, every 4 h as needed, and IV hydromorphone, 5 mcg/kg, available for breakthrough pain every 2 h were started. The acetaminophen was switched from the IV route to the PO route. The gabapentin, diazepam, cyclobenzaprine, and ketorolac were continued. The scheduled ondansetron was changed to as needed every 6 h.On POD 3, the paravertebral nerve catheter infusions were continued. If the hydromorphone PCA was not discontinued the day prior, it was discontinued on POD 3. The oxycodone was adjusted to 0.15 to 0.2 mg/kg, a maximum of 10 mg/dose, every 4 h as needed for pain control. The ketamine infusion was discontinued, while the acetaminophen, gabapentin, diazepam, and cyclobenzaprine were continued. The ketorolac was switched to ibuprofen 4–10 mg/kg every 6 h with a maximum dose of 3200 mg/daily. The catheters were suspended and removed if the patient’s pain was controlled well.On POD 4, the paravertebral nerve catheter infusions were suspended at 6 a.m. and removed at 10 a.m. if the patient’s pain was controlled with the other multimodal analgesics. The acetaminophen, cyclobenzaprine, ibuprofen, and oxycodone were continued until the patient’s discharge home.At the end of the surgery, 0.5 mg/kg of ketorolac (max dose 15 mg) was administered unless the surgeon contraindicated.On POD 0, infusions through the bilateral paravertebral nerve catheters were initiated with 0.2% ropivacaine with 1 mcg/mL of clonidine at a rate of 8 mL/h on each side, with 2 mL clinician boluses administered by the nurse every 180 min on each side as needed. Each patient was also given a hydromorphone PCA, with the same demand and clinician bolus amount but without continuous infusion. Ketorolac was continued at 0.5 mg/kg (maximum dose 15 mg) every 6 h. The rest of the medications for pain control  and to prevent nausea were similar. Gabapentin was not started.On POD 1, the paravertebral nerve catheter infusions were adjusted as necessary to improve pain control. The hydromorphone PCA was discontinued at the end of the day. Oxycodone 0.1 mg/kg every 6 h and IV hydromorphone 5 mcg/kg every 2 h for breakthrough pain were started. Gabapentin was administered only in the case it was indicated for pain control. The rest of the medications for pain control and to prevent nausea were similar.On POD 2, the paravertebral nerve catheters were continued. The ketamine infusion was discontinued. In addition to the previous opioids, 5 mg of as-needed oxycodone every 4 h was added. The rest of the medications for pain control and to prevent nausea were similar. The catheters were suspended and removed if the patient’s pain was controlled well.On POD 3, the paravertebral nerve catheter infusions were suspended at 6 a.m. and removed 4 h later if the patient’s pain continued to be well controlled. The oxycodone could also be adjusted to 0.15 mg/kg every 4 h for pain, a maximum of 10 mg/dose. The rest of the medications for pain control and to prevent nausea were similar.On POD 4, if the paravertebral nerve catheters were still in situ, they were suspended and removed.A few differences between these two protocols facilitated a quicker transition from the PCA at the end of POD 1 rather than on POD 2 and the removal of paravertebral catheters POD 3 rather than POD 4. These included adding clonidine to the paravertebral nerve catheters, removing the continuous infusion on the hydromorphone PCA, and starting ketorolac in POD 0. The addition of scheduled oxycodone with as-needed supplemental oxycodone facilitated the discontinuation of the ketamine infusion on POD 2 rather than POD 3.Practical Pain Management Journal ).Outcomes were analyzed by postoperative day with POD 0 defined as the end of surgery to midnight of the same evening. POD 1 started at midnight after surgery and extended for 24 h. The data were collected in this manner until discharge. Total intravenous and enteral opioid consumption was collected for each POD and converted to morphine equivalents using the opioid equivalency table used by the Descriptive statistics were summarized as frequencies  for categorical data or as the median and interquartile range for non-normally distributed continuous data. Examination of normal distribution assumption for continuous data was determined by q-q plots and histograms. Wilcoxon–Mann–Whitney test was performed to determine differences between groups for non-normally distributed continuous data, respectively. Pearson’s chi-square or Fisher’s exact test, as appropriate, was used to compare the frequency distribution of categorical variables between the groups. For NRS pain scores and morphine equivalents of opioid consumption data, linear mixed-effects models were used to test the main effects of group (old protocol versus new protocol), time  and time by group interactions and to account for within-subject correlation. One between-subjects factor (group) and one within-subjects factor  and their interaction were defined as fixed effects and the subject as a random effect. For NRS pain scores, the analyses were adjusted by NRS pain scores during PACU. For linear mixed-effects models, logarithm base 10 transformations were used for morphine equivalents of opioid consumption data. After inspecting the correlation within subjects, an autoregressive structure was assumed. Due to discrete medication doses, low number (N) comparisons, and low-frequency administration of certain drugs, interquartile ranges (IQRs) may show all zeros. This is not an error and shows that at least three-quarters of the comparable sample received no dose and suggested uncommon medication used in this study. All analyses were two-sided, and the significance level was set to 0.05. The data were analyzed using SAS .Sixty-three patients were included in the study . Forty-fp = 0.013). The new protocol group had a higher percentage of patients undergoing general anesthesia for the placement of nerve blocks . In comparison, the old protocol group had a higher percentage of awake patients with sedation for nerve block placements . The new protocol group had longer anesthesia times  min vs. 178.0  min, p = 0.057) and surgical times  min vs. 79.0  min, p = 0.02) compared with the old protocol group.The main differences between the two groups included a higher Haller index in the new protocol group ) compared with the old protocol group , There was no difference in median NRS pain scores between the two groups on all postoperative days, although the pain scores were lower in the new protocol group .p = 0.068) (p = 0.002)  in the new protocol group vs. five patients (11%) in the old protocol group, = 0.068) . The amo= 0.068) . The med= 0.002) .There were no differences in catheter infusion duration and hospital length of stay .The 2 adrenoreceptors, but some studies suggest alternative mechanisms of action and target sites. It is described as an adjuvant to local anesthetics [Clonidine is known to act on αsthetics  and it isthetics ,17,18,19p = 0.002). This almost 50% reduction in opioid requirement on POD 2 is clinically significant because the clonidine group had higher Haller indices  vs. 4.8 , p = 0.013). Higher Haller indices indicate severe pectus repair and more postoperative pain to correct severe surgical pain.Pain after the Nuss procedure is challenging to treat; ultrasound-guided continuous paravertebral blocks can be considered for pain control. In this cohort study, 18 patients with bilateral continuous paravertebral blocks received a combination of ropivacaine 0.2% and clonidine 1 mcg/mL. They were compared with 45 patients who received only ropivacaine 0.2% infusion. The clonidine group required less morphine equivalent/kg on a postoperative day 2  vs. 0.47  Despite the minute changes we made between our old and new protocols within our institution , there was very little difference seen in pain scores and opioid consumption between the two groups. The decrease in opioid consumption on POD 2 may reflect overall changes in the new protocol, which included adding clonidine to the paravertebral infusion. Despite removing continuous infusion of opioids, there was no increase in the pain scores on the day of surgery and PCA hydromorphone was discontinued on POD 1. Perhaps our results were not more pronounced because of the significantly higher Haller indexes in the clonidine group, which added a higher pain burden that was better treated with clonidine.Other studies show improved pain control and decreased opioid consumption with clonidine in a paravertebral nerve block ,21. MayuAccording to the Society for Pediatric Anesthesia Improvement Network (SPAIN) study, only two out of fourteen institutions performed paravertebral nerve blocks for Nuss patients. In contrast, the majority performed thoracic epidurals . None ofThe lack of difference in nerve catheter infusion duration and hospital length of stay duration can be explained by the inherent post-surgical course, specifically the presence of the chest tube. Another explanation can be related to our initial informal goal of suspending the paravertebral catheters on POD 3 in the old protocol that was subsequently formalized in the new protocol, therefore not much difference in nerve catheter duration was seen. After that, because the nerve catheter must be discontinued before discharge with the assurance of continued pain control on an oral pain regimen, it is not surprising that the hospital stay is about 24 h longer than the nerve catheter infusion duration.Recently, intercostal nerve cryoablation (INC) has been performed to improve pain control after the Nuss procedure . This prOur study is limited by its retrospective nature. Patients were not randomly assigned to different treatment protocols or a control group; thus, it is difficult to assess the actual degree of differences in pain scores and opioid consumption as well as hospital length of stay. Our limited sample size leads to further limitations in detecting more significant differences between the two protocols. In addition, we did not evaluate essential functional outcomes  in the perioperative period or the incidence of hypotension or bradycardia. Secondly, we did observe changes in practice patterns shortly after completing this study, and a tendency toward using INC increased over the last years. In our institution, continuous paravertebral nerve blocks with ropivacaine 0.2% and clonidine 1 mcg/mL are performed for a group of patients who undergo INC. PCA with hydromorphone was removed from our multimodal pain protocol for pediatric patients undergoing the Nuss procedure.The addition of clonidine (1 mcg/mL) to bilateral paravertebral ropivacaine 0.2%, 8 mL/h, as part of a multimodal analgesia approach reduced postoperative opioid requirement after the Nuss procedure. Additional large prospective studies are needed to fully evaluate the efficacy and safety of perineural clonidine infusion in pediatric populations.


The Numerical Rating Scale (NRS) and Patient-rated wrist/hand evaluation (PRWHE) are patient-reported outcomes frequently used for evaluating pain and function of the wrist and hand. The aim of this study was to determine thresholds for minimal important difference (MID) and patient acceptable symptom state (PASS) for NRS pain and PRWHE instruments in patients with base of thumb osteoarthritis.th percentile and the ROC curve methods. The anchor question for MID was the change perceived by the patient compared with baseline; the anchor question for PASS was whether the patient would be satisfied if the condition were to stay similar. The correlation between the transition anchor at baseline and the outcome at all time points combined was calculated using the Spearman’s rho analysis.Fifty-two patients with symptomatic base of thumb osteoarthritis wore a splint for six weeks before undergoing trapeziectomy. NRS pain (0 to 10) and PRWHE (0 to 100) were collected at the time of recruitment (baseline), after splint immobilization prior to surgery, and at 3, 6, 9 and 12 months after surgery. Four anchor-based methods were used to determine MID for NRS pain and PRWHE: the receiver operating characteristics (ROC) curve, the mean difference of change (MDC), the mean change (MC) and the predictive modelling methods. Two approaches were used to determine PASS for NRS pain and PRWHE: the 75The MID for NRS pain was 2.5 using the ROC curve method, 2.0 using the MDC method, 2.8 using the MC method, and 2.5 using the predictive modelling method. The corresponding MIDs for PRWHE were 22, 24, 10, and 20. The PASS values for NRS pain and PRWHE were 2.5 and 30 using the ROC curve method, and 2.0 and 22 using the 75th percentile method, respectively. The area under curve (AUC) analyses showed excellent discrimination for all measures.We found credible MID estimates for NRS and PRWHE , although the MID estimates varied depending on the method used. The estimates were 20-30% of the range of scores of the instruments. The cut-offs for MID and PASS showed good or excellent discrimination, lending support for their use in future studies.This clinimetrics study was approved by the Helsinki University ethical review board (HUS1525/2017).The online version contains supplementary material available at 10.1186/s12874-022-01600-1. The thumb accounts for about half of the function of the hand and plays a key role in manipulating objects . FunctioThe Visual Analogue Scale (VAS) and the Numeric Rating Scale (NRS) are the most frequently used unidimensional measures for hand pain. Other outcome measures, such as the Patient-Rated Wrist/Hand Evaluation (PRWHE) and the Australian Canadian Osteoarthritis Hand Index (AUSCAN), are typically used to assess hand function and disability –7. ValidThe MID concept was introduced over 30 years ago and became a gold standard in evaluating the clinical relevance of trial results . It repr. Predefined PASS values may prevent manipulation of the cut off in responder analyses and improve the interpretability of clinical trial findings [Patient acceptable symptom state (PASS) was introduced more recently, and thus, its use is less common in musculoskeletal research . PASS refindings , 15.The aim of this study was to define the MID and PASS thresholds for NRS pain and PRWHE in patients undergoing surgery for base of thumb osteoarthritis.Participants were recruited at the Central Finland Central Hospital, the Tampere University Hospital and the Helsinki University Hospital between August 2017 and November 2018. The study protocol was approved by the Ethical Review Board of Helsinki University Hospital (HUS 1525/2017) and local Institutional Review Boards.This is a prospective cohort study. Three experienced hand surgeons screened all patients who were referred for surgical consultation for radiologically verified base of thumb osteoarthritis at the participating secondary or tertiary referral hospitals. Prior to recruitment, all participants were scheduled for surgery because non-operative treatment had not relieved their symptoms. The specific inclusion criteria were: 1) thumb osteoarthritis with symptoms affecting activities of daily living, 2) a present indication for surgical treatment of base of thumb osteoarthritis based on radiographic and clinical findings, and 3) age >45 years. The exclusion criteria were: 1) symptoms likely due to something other than base of thumb osteoarthritis, 2) the presence of a neurological condition that may affect hand function, 3) surgical treatment of the hand within the previous 6 months, 4) an inflammatory condition affecting joints, 5) the presence of an indication for bilateral surgery for base of thumb osteoarthritis, or 6) >45º hyperextension in the thumb metacarpophalangeal joint (zig zag -deformity). The recruitment procedure is presented in Fig. Participants were informed about the study and gave informed consent. Thereafter, all participants received a removable splint  to wear full time for 6 weeks before surgery. The intent of preoperative splinting was to provide a uniform and systematic approach to non-operative treatment, in addition to the different forms of non-operative treatment issued before referral to surgical consultation. Our approach allowed for a time point of clinical evaluation and collection of data following this 6-week period of non-operative treatment. In the surgical intervention, a simple trapeziectomy, in which the trapezium was removed completely, was performed. After the operation, the wrist and the thumb were immobilized in a thumb spica cast for 3 weeks, followed by 3-week immobilization with a removable splint.At baseline, we collected the following data from participants: age, sex, handedness, affected side, use of tobacco products, radiological staging of the thumb basal joint osteoarthritis (Eaton-Glickel) , and heiWe collected NRS pain and PRWHE at the baseline, after 6 weeks of splinting prior to surgery, and at 3, 6, 9, and 12 months after surgery. For NRS pain, the participants were asked to rate average pain intensity in activities of daily living during the previous day by selecting a value from 0 to 10 (0 indicating no pain and 10 indicating the worst pain imaginable). PRWHE is a 15-item questionnaire, in which patients rate their level of wrist/hand pain and disability on a scale from 0 to 10 for each item. PRWHE consists of independent subscales for pain and for hand/wrist function. Both subscales are scored from 0 to 50, and thus the total score is from 0 to 100 (0 is the best and 100 is the worst possible score) , 18. A hAs an anchor question for determining the MID,  participChange in NRS pain and PRWHE scores were calculated for each patient by subtracting the score at the time of follow-up from the baseline score. We used data from all time points in the analyses, i.e., each participant provided an anchor question–outcome measure data pair at each of the five follow-up timepoints. To assess the adequacy of the anchor question, we calculated Spearman's correlation between the anchor question and 1) baseline score; 2) follow-up score; and 3) change score, and values >0.5 were considered sufficient as suggested by Devji et al. . 95% conFour different approaches were used to determine the MID: 1) For the mean change method (MC) we calculated the mean value for participants who reported “somewhat better” on the GRC; 2) for the mean difference of change method (MDC) we calculated the mean difference between those who had reported “somewhat better” and those who reported “no change” on the GRC; 3) for the Receiver Operating Characteristics (ROC) curve method we dichotomized the GRC between “no change” and “somewhat better”, excluding participants who reported “somewhat worse” or “much worse” , and forth percentile method [th percentile score for both NRS pain and PRWHE in the distribution of the patients who considered themselves to be in an acceptable symptom state.To determine the PASS, we used two methods: 1) the ROC curve, similar to the method used for the MID analysis (cut off-point discriminating between an acceptable versus a non-acceptable symptom state); and 2) the 75e method , 28. TheFifty-two participants were recruited into the study; two did not attend the follow-up visits. Thus, we had data from 50 participants at five follow-up time points (250 outcome–anchor question pairs). We did not define MID values for all separate time points due to the low number of participants reporting no change in global rating of change at several time points. Also, as correlations between GRC and the change of the target instrument were low at some time points , PRWHE total score from 0 to 100, PRWHE pain and function subscales from 0 to 50 .MID values from the mean difference of change method, mean change method and predictive modelling method were higher than the MID values calculated using the ROC curve method for PRWHE pain and PRWHE total Table . The MIDThe correlation between the GRC and the post scores and the change of the target instrument  were at an acceptable level (>0.5)  for the PASS values derived using the ROC curve method were slightly higher than those derived by the 75th percentile method, but both methods yielded values that were 20%-25% of the NRS pain range of scores, and 20%-34% of the range of the PRWHE total score or of its subscales. The AUCs implied excellent discrimination for all outcome measures  ranged from roughly 20 to 30% of the scale of the instrument depending on the method used. Most importantly, the obtained cut-offs for both instruments showed good or excellent discrimination – essentially, the MID cut-offs distinguishing “those with at least some improvement” from “those with no improvement” and the PASS cut-offs “the satisfied” from “the unsatisfied”. These findings suggest that the MID and PASS estimates for NRS pain and PRWHE found in this study may be sufficiently robust for drawing interferences on the clinical meaningfulness of different studies on patients with base of thumb osteoarthritis using these outcome instruments.High internal validity is an obvious strength of our study: We used four different, established methods to estimate the MID value and two methods to estimate the PASS value, and the study was conducted by a staff with ample clinical research background. Experienced staff (hand surgeons and assisting personnel) ensured uniform indications for surgery, the homogeneity of the study population, and strict adherence to the pre-specified study protocol (2/52 or 4% loss to follow-up). In addition, we consider our anchor question for PASS to be sufficiently clearly defined for assessing the patients’ overall satisfaction.n=50) study population compelled us to combine all follow-up time points, and accordingly, we could not assess whether the MID and PASS estimates vary as a function of time.Our study also had limitations. The relatively small  and PASS for NRS pain for patients undergoing proximal interphalangeal (PIP) joint arthroplasty , and estMID and PASS for PROMs used in hand surgery have been sparsely studied, particularly for patients with osteoarthritis at the base of the thumb. MID estimates have, however, been defined for diverse populations of patients with hand surgery , 34. ForRegarding the determination of MID and PASS estimates more broadly, our findings are well aligned with the existing understanding that there is a variability in the MID estimates between different methods and different outcome measures . The higWhen evaluating the results of operative treatment in patients with base of thumb osteoarthritis, the clinical applicability of MID is that it can be used 1) to assess the relevance of between group differences, if comparing different surgical techniques, and 2) to estimate the proportion of patients who noticed a change in their condition and were satisfied with the result (i.e. to identify the proportion of the patients for whom operative treatment could be considered worthwhile ). PASS cFuture research could investigate the effect of time on MID and PASS estimates and examine the underlying causes for the variation in the MID and the PASS estimates with regard to the method of analysis used.This study defined the MID and the PASS estimates for NRS pain, PRWHE total, and the PRWHE pain and function subscales, in patients who received surgery for symptomatic osteoarthritis at the base of the thumb. The MID estimates varied depending on the method used. The MID values determined in this study for all these outcome measures appear credible, as the GRC correlates well with the post score and the change on the target instrument. The cut-offs for both MID and PASS showed good or excellent discrimination, suggesting that they could be meaningful in interpreting NRS pain and PRWHE scores in studies evaluating the effect of surgery for patients with osteoarthritis at the base of the thumb.Additional file 1: Table S1. Correlations between post scores and GRC. Table S2. Correlations between GRC and the change of the target instrument. Table S3. Correlations between GRC and target instrument baseline scores.


Rotator cuff (RC) tendinopathy is a common shoulder pain condition. Extracorporeal shockwave therapy (ESWT) and hyaluronic acid peritendinous injection are viable treatment options for RC tendinopathy.The aim of this study is to evaluate the response in two different therapeutic rehabilitative approaches, the combined treatment ESWT plus hyaluronic acid injections (E + Hy) compared to ESWT alone , in a cohort of patients with RC tendinopathy according to gender differences.This is a retrospective longitudinal cohort study of patients with painful RC tendinopathy. Patients that had received a clinical evaluation, a shoulder ultra sound examination, as well as the Shoulder Pain and Disability Index (SPADI) questionnaire, and the Numerical Rating Scale (NRS) for pain at baseline, 1-month (T1) and 2-month follow-ups (T2) were included.p < 0.001) and in the SPADI (p < 0.001) in the entire study group. At T1, patients in the E + Hy compared to ESWT-al group, showed a slight but statistically significant reductions in both NRS and SPADI score, while these changes were more evident at T2 (p < 0.001). Interestingly, a gender dimorphism in NRS and in SPADI was found, with female patients that apparently responded better to the combined E + Hy compared to ESWT-al approach.Medical records of 53 patients were analyzed. In the comparison between baseline to T1 and similarly from baseline to T2, a statistically significant reduction has been reported in the NRS (This retrospective cohort study suggests that the combination of ESWT plus HyA injections seems to be more effective than ESWT alone in RC tendinopathy in both genders. Moreover, in ESWT alone treatment, male patients reported better outcomes compared to females. However, further randomized controlled trials should be structured to confirm and enforce these conclusions.The online version contains supplementary material available at 10.1186/s12891-022-05819-3. Shoulder pain is a common clinical complaint, with a point prevalence reported ranging from 7 to 26% in the general population, with a lifetime prevalence of up to 67% . The incAmong shoulder pain problems, rotator cuff (RC) pathology is one of the more common conditions for which patients seek treatment ; in partIn the context of the surgical approaches, several arthroscopic procedures are proposed for rotator cuff tears. Among them a tear completion repair (TCR) technique, in the mid-term as in the long-term follow-up, showed good outcomes in terms of functional and strength recovery, patient satisfaction, and resolution of pain , 8.General consensus showed that tendinopathy, at least in the chronic stage, is mainly a degenerative condition, inflammation plays a minor role . As mattSeveral possible mechanisms have been proposed for the effect of ESWT, including overstimulation of nociceptor that produces an analgesic effect, or microlesions of the tendon tissue by the physical effects of the sound waves  ending in the promotion of a healing process of the tendon . The sucNumerous clinical studies have demonstrated the therapeutic capacity of exogenous peritendinous hyaluronic acid (HyA) injection in reducing pain, improving function and reducing tendon rubbing in pre-insertion areas in the course of the different tendinopathies , tendon injuries and tendon reparative post-surgery . PreclinAn overall difference was reported in disability recovery, and response to shoulder pain treatment between men and women . In partThe objectives of this study were to investigate the effectiveness in terms of pain and disability of ESWT plus Hyaluronic Acid injections (E + Hy) compared to ESWT-alone  in patients with painful RC tendinopathy, as well as to compare the overall treatment response between male and female patients.We performed a retrospective longitudinal cohort study including medical records of patients with painful RC tendinopathy, referred at the Chiparo Physical Medicine and Rehabilitation outpatient in Lecce between July 2021 and December 2021. The study was planned at the Clinical Research Department of the Ludes Campus in Lugano (CH), and complies with the STROBE guidelines of the Consort Statement for the reporting of observational studies.To be eligible, patients had to be between 30 and 65 years old, with shoulder pain intensity at the Numerical Rating Scale (NRS) of at least 5, and had to be negative on screening for other sources of pain outside the shoulder . The diagnosis of RC had to be confirmed by US evaluation showing structural inhomogeneity and altered tendon thickness . PatientThe study was developed following the Good Clinical Practice (GCP) guidelines. It was conducted within the ethical principles outlined in the Declaration of Helsinki, and with the procedures defined by the ISO 9001-2015 standards for “Research and experimentation”. Written informed consent to provide information included in personal medical records were obtained from all participants.Clinical data , US examination of the shoulder, as well as a disability evaluation assessed by the Shoulder Pain and Disability Index (SPADI) questionnaire were collected , 24. TheBoth groups  received three sessions of ESWT , administered by the same operator. For each single therapeutic session with ESWT, 2000 pulses emitted by focused shock wave generator (piezoclast-EMS ESWT) with a range of energy flux density between 0.11–0.28 mmJ/mm2 and a frequency between 6 and 8 Hz were administered. The treatment was administered regularly, and titrated up to remain perceived as ‘strong but comfortable’ during use. Patients were seated, and the affected shoulder was positioned in adduction and internal rotation with the elbow in flexion and the palm resting on the back during the execution of the first 1000 impulses and then upper limb in neutral position of shoulder rotation with arm along the trunk for the next 1000 impulses.peritendinous area of the supraspinatus using real-time US guide infiltration (SonoSite M-Turbo ultrasound system with a 6–15 Mhz linear probe). Peritendinous infiltration with HyA was administered twice more, at day 18 and 25 from last ESWT session. Injection was done using a pre-filled syringe of 20 mg in 2 ml sodium salt of linear HyA with molecular weight 500–730 kDa, with 21G 40 mm needles. No anesthetic drugs were administered before and after the treatment. During the procedure, patients were seated, and the affected shoulder was positioned in adduction and internal rotation with the elbow in flexion and the palm resting on the back. The skin was disinfected with a chlorhexidine wipe.Only E + Hy, 4 days after the last therapeutic ESWT session, received HyA in the After intervention, both study groups underwent a 45 minutes/session, twice a week, for 6 weeks period of rehabilitation exercise with physiotherapist, consisting in a standardized protocol including: a) Protraction of the scapula; b) closed chain scapulo-thoracic contraction; c) closed chain protraction of the scapula; d) wall slide; e) upward rotation of the scapula; f) retraction of the scapula .Data were reported as mean ± standard error (S.E.) for continuous variables and as absolute number and percentage for dichotomous variables; differences between groups were assessed with analysis of variance and chi-square test, respectively. To assess the variation of SPADI-score, and NRS during the study, Linear Mixed Models were applied . Intercep-value for differences was considered statistically significant for a value less or equal to 0.05.In the both LMMs were considered the: two treatments, with ESWT-al as the reference group; the three times of the study, with baseline as the reference; the interaction between time and treatment; sex effect, with female as the reference; the interaction between time and sex to assess gender differences in the response to treatment; shoulder side treated, with left as the reference; and lastly age as a continuous variable. Data were analyzed with SAS-software (rel. 9.4), and p-value = 0.45), whereas a statistically significant difference was found for age according to treatment . Twenty patients (37.7%) reported pain at the left shoulder, whereas 33 on the right shoulder without statistically significant differences between the two treatment groups . The mean NRS was 6.6 ± 1.0, and the mean SPADI-score was 47.8 ± 10.4 in the study cohort. No statistically significant differences in both outcome measures were found according to sex . In Tables p-value< 0.001; − 1.87 ± 0.34; p-value < 0.001, for Follow-up-1 and Follow-up-2, respectively). E + Hy group compared to ESWT-al showed a slight but significant reduction in the NRS at the follow-up-1 , and this change was more evident at follow-up-2 . Taking into account the NRS change according to sex, male patients reported statistically significant pain relief at the follow-up-2 compared to female sex . Lastly within person variance in the NRS in function of time was 88.7%.Medical records of 53 patients, 22 41.5%) males, and 31 (58.5%) females, were collected, including 33 patients in the combined treatment group (E + Hy), and 20 patients in the ESWT-al group. Mean age for study cohort was 53.0 ± 7.4 (range 40–65); no statistically significant differences were found for age according to sex  and in follow-up-2  compared to baseline were reported in the study cohort, independently from the treatment group. According to time points and treatment group, a multiplicative effect for the interaction was found, as matter of fact that mean SPADI-score in E + Hy group significantly decreased from baseline at both follow-up-1 and follow-up-2,  compared to ESWT-al group.For SPADI statistically significant changes in follow-up-1 . Lastly within person variance in the SPADI in function of time was 95%. To verify if a gender difference in terms of NRS and in SPADI changes could be attributable to the different type of intervention, the same approach with Mixed-Model was applied and analyses were stratified according to treatment. In male patients a similar response through times of the study according to different therapeutical approach could be found. Interestingly, female patients apparently respond better to a combined E + Hy compared to ESWT-al approach . According to the NRS, female patients of the E + Hy group reported statistically significant pain relief at follow-up-1, while both genders reached similar results at follow-up-2. In the ESWT-al group, male patients reported lower pain intensity at follow-up-1, and the trend of this change was confirmed also in follow-up-2 , between sex, in the same treatment group at follow-up-1. At follow-up-2, only male patients reported pain relief, while female patients did not, those differences in NRS between sexes become statistically significant . We also performed a stratified analysis only on female, to compare the variation trend in NRS and in SPADI according to treatment approach, that showed a multiplicative effect  for pain and disability of the shoulder  also considering potential gender-difference in the treatment response in a cohort of patients with RC tendinopathy. Our findings suggest that E + Hy results in better and faster response compared to EWST-al in terms of pain relief and disability reduction. Also, these results were maintained at the follow-ups with a further symptomatic improvement in the E + Hy group. According to literature, peritendinous injections of HyA seem to be effective in reducing pain and to improve functions in patients with RC tendinopathy , 29, altHyaluronic acid enhances the fibroblasts activity, including their adhesivity, extracellular matrix synthesis, and proliferation, although its effect on the biomechanical properties of tendon is still not clarified –32. Our Among limitations to be accounted, the main relevant one deals with the retrospective study design that might be affected by several bias (e.g. selection bias). For example, as a retrospective study the allocation of patients in the two groups did not follow a randomization procedure; patients were assigned to one of the two groups according to the information contained in the medical records. Therefore, a healthy worker effect could be introduced; as matter of fact, those patients who participate in the E + Hy group represent subjects that are particularly interested in their performance and in their autonomy in self-care and could have more expectations for treatment success. The lack of an experimental design could not enable us to control for potential confounding factors  that could modulate and influence the performance, and the rehab process itself. We try in the analytic approach to compensate through a multivariate statistical analysis for potential confounding factors, as age, sex or side of the treated shoulder, but this approach could not be considered exhaustive. Synthetically, the external validity of this study is at least questionable, but the statistically significant differences found, and the biological plausibility of the results, could represent at least the basis to design a randomized clinical trial focused on the comparison between different approaches in the treatment of shoulder pain.Our study supports the hypothesis that a multimodal approach might provide additional benefits without safety concerns in patients with RC tendinopathy independently of gender. In particular, our retrospective investigation showed the effectiveness of combined intervention of ESWT and HyA injections over ESWT alone in subjects affected by RC tendinopathy in both men and women. However, in those receiving ESWT alone, men reported higher benefits in terms of pain relief compared to women. Despite these encouraging findings, randomized controlled trials are required to prove the efficacy of the proposed approach in patients with RC tendinopathy, also considering gender-related patterns of treatment response.Additional file 1.


The purpose of this study was to observe the clinical efficacy of the reinforcing and circulation-promoting protocol of acupuncture and moxibustion in treatment of refractory chronic low back pain, analyze therapeutic principles to obtain treatment efficacy, and develop new therapeutic principles to treat chronic low back pain.  Twenty-four patients from the registry of patients suffering from refractory chronic low back pain were invited to our self-controlled case series, which was conducted in “real-world” settings. We implemented the reinforcing and circulation-promoting protocol of acupuncture and moxibustion to treat these patients and used the Visual Analogue Scale (VAS) and the Oswestry Disability Index (ODI) as the observation indices. P < 0.001). The ODI was 28.21 ± 13.06 before treatment and 16.63 ± 7.20 after treatment. Their difference before and after treatment was significant (P < 0.001).  All 24 patients completed the treatment of acupuncture and moxibustion. The VAS of low back pain was 6.83 ± 2.18 before treatment and 2.13 ± 1.45 after treatment. The difference before and after treatment was significant (AMCTR-OOO-17000045 (3 December 2016). The reinforcing and circulation-promoting protocol of acupuncture and moxibustion is effective in treating refractory chronic low back pain mainly because low back pain can be significantly relieved and motor function can be promoted. This trial was registered with  Chronic low back pain (CLBP) is one of the most common chronic pain problems in the world. In Medical Subject Headings ((MeSH), CLBP is defined as “acute or chronic pain in the lumbar or sacral regions, which may be associated with musculo-ligamentous sprains and strains, intervertebral disc displacement, and other conditions” . Among cIn China, the practice of acupuncture-moxibustion to treat CLBP has a long history. First recorded in Prescriptions for Fifty-two Diseases (Wushier Bingfang) is the assertion that a problem with the bladder meridian of foot-taiyang can cause the back, low back, and gluteal region to ache . ChapterIt is documented in many ancient medical books that CLBP was treated by puncturing a single distant point. Much of the medical literature in the late twentieth century describes the practice of distant–local point combination. Mainly used were points in the bladder meridian of foot taiyang, the governor vessel, and the gallbladder meridian of foot shaoyang, five transport points, crossing points, and back-shu points. However, at present, CLBP is often treated with acupuncture on Ashi and Jiaji points. Since the treatment principle of treating CLBP with acupuncture on Ashi points and points along the affected meridian is widely followed, currently, many traditional Chinese medicine (TCM) practitioners treat the pain by puncturing points in the back, low back, and lower limbs while ignoring the points on the abdomen and nonaffected meridians.In terms of acupuncture therapy, TCM practitioners normally use traditional needling techniques such as the filiform needle therapy, bloodletting, and fire needling and modern techniques such as electroacupuncture and myofascial trigger points , 13. In According to the Agency for Healthcare Research and Quality , “a patiThis study was reviewed by the Ethics Committee of the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences (CACMS), through 2016NO.13. It was registered on 3 December 2016 at the Chinese Clinical Trial Registry (ChiCTR–OOC–17010751) and the Acupuncture and Moxibustion ClinicalQ3 32 Trial Registry (AMCTR–OOO–17000045).The data were collected between 2017 and 2021. Twenty patients were hospitalized because they had obvious pain and motor impairment, while four were treated in the outpatient department. These four patients had pain and motor impairment as much as the inpatients. It was more difficult to treat them since they had high workload and sat or stood for a long time and consequently did not have good rest during the period of treatment see .12 weeks of pain or muscle tension below the chest and above the gluteal region, no matter whether there is pain in the lower limbsDiagnostic information including determined causes, medical history, symptoms, physical examination, and/or imaging data.According to Evidence-based Guidelines of Clinical Practice with Acupuncture and Moxibustion (2014) published by the China Association of Acupuncture and Moxibustion, Diagnosis and Treatment of Low Back Pain (2007) by the American Medical Association and American Pain Society, and Low Back Pain and Sciatica in Over 16s: Assessment and Management (2016) by the National Institute for Health and Care Excellence, the diagnosis of CLBP is based on the following criteria:Those who were eligible for clinical observation should meet the following conditions: (1) they had a chief complaint of CLBP and met the diagnostic criteria mentioned above, (2) they were between 16 and 65 years old, (3) they had an acute stage and/or subacute stages of CLBP, (4) they were willing to receive acupuncture treatment, and (5) they were willing to participate in the case registration study and signed the informed consent.Patients were excluded if they had one of the following conditions: (1) they had a severe systemic disease such as a primary disease of the cardiovascular system, liver, kidney, or hematopoietic system, (2) they had severe psychosis, and (3) their low back pain was caused by tumor, infection, or trauma.Patients were excluded if they could not complete the treatment due to personal reasons or received other treatment during our study period.We recruited twenty-four patients with low back pain and motor impairment as chief complaints, including seventeen cases with lumbar intervertebral disc degeneration and four cases who have a problem with the spine. Basic information of the patients' medical conditions and the types of pain they have are presented in Tables In this study, we adopted the criteria of syndrome differentiation described by the Chinese National Standard for Diagnosis and Curative Effect of Syndromes in Traditional Chinese Medicine and Diagnostics of Traditional Chinese Medicine. Our practitioners who had had relevant training used the criteria to conduct syndrome differentiation, namely, to identify deficiency syndrome and excess syndrome. The excess syndrome includes obstruction of cold-dampness, qi stagnation and blood stasis, obstruction of dampness-heat and cold-dampness, and blood stasis. The deficiency syndrome is assessed based on the following clinical manifestations: (1) the duration of the disease was long, (2) acute pain transitions to chronic pain, (3) the pain accompanied by soreness, numbness, and heaviness in the lumbus is referred to the lower limbs, (4) the pain may be dull, (5) the pain can be relieved by warmth and pressure, (6) the muscles of the lumbar and lower limbs are soft and weak, (7) the pain can be aggravated by tiredness and cold invasion and sometimes accompanied by soreness and weakness in the lumbus and knees, (8) a patient suffers from mental fatigue, (9) a patient has a slightly or dark red tongue as well as scanty coating, and (10) a patient's pulse is either deep, thready and weak, or thin and string-taut.Obstruction of cold-dampness: most of the patients with this syndrome have experience of exposure to wind, cold, and damp conditions. They have pain and sensation of heaviness or cold in their lumbus. They may also have difficulty bending forward or backward. In addition, the pain is paroxysmal and can be referred to the lower limbs and aggravated by cold, wind, or rainy weather. The patients have a white and greasy tongue coating. Their pulses may be superficial and tense, deep, or deep and tense.Qi stagnation and blood stasis: most of the patients with this syndrome have experience of weight bearing, meridian damage, sudden strain of a muscle, qi stagnation, blood stasis, and acute lumbar sprain and have experience working for a long time bending forward. The patients have back stiffness and stabbing pain in the fixed location of their lumbus. The pain is aggravated by pressure. They have a dark red tongue or a tongue with ecchymosis. In addition, their pulse is chopping or string-taut and chopping.Cold-dampness and blood stasis: palpation can detect subcutaneous nodules, cysts, steaks, and cold spots and swollen, cold, and stiff soft-tissues in painful areas.Obstruction of dampness-heat: patients with this syndrome have pain with burning sensation in their lumbus and weakness in their lower limbs. The pain is aggravated by warmth or rainy weather but relieved by exercise. A patient's thirst is induced by heat. Their urine is scanty and deep yellow. Their tongue coating is yellow and greasy. Their pulse is either soft and rapid or string-taut and rapid.The excess syndrome is assessed based on the following clinical manifestations:During treatment, we combined the reinforcing method with the circulation-promoting method. However, based on syndrome differentiation of deficiency and excess, we primarily used either of them. The main points we selected were back-shu points and points in the governor vessel and related meridians.We used the reinforcing method to treat patients with the deficiency syndrome. We mainly punctured points on the abdomen by the filiform needle therapy to tonify the consumption and regulate the circulation of blood and qi between zang-fu organs. On the other hand, we used the circulation-promoting method to treat patients with the excess syndrome. We mainly selected Ashi points. After we had identified the nature of a pathogen, we used one or several techniques of acupuncture-moxibustion. Specifically, we used warming needle moxibustion or moxibustion to treat our patients with obstruction of cold-dampness. For patients with qi stagnation and blood stasis, we applied the filiform needle therapy to regulate the circulation of qi and activate blood. For patients with cold-dampness and blood stasis, we applied the fire needling therapy or warming needle moxibustion not only to expel cold-dampness and blood stasis but also to warm and unblock meridians and collaterals. In addition, we used the bloodletting cupping therapy to treat patients with damp-heat obstruction.Basically, we selected points from the back-shu points, points in the governor vessel, and points along the affected meridians. To be specific, the back-shu points include Pishu (BL20), Shenshu (BL23), Dachanghu (BL25), Sanjiaoshu (BL22), Qihaishu (BL24), Xiaochangshu (BL27), and Pangguangshu (BL28). According to the location of pain, we followed the treatment principles of covering the affected area and using as few acupoints as possible to select the back-shu points in the affected segment. The points normally selected were Pishu (BL20), Shenshu (BL23), Dachangshu (BL25), and Zhibian (BL54); points along the governor vessel include Jizhong (GV6), Mingmen (GV4), Yaoyangguan (GV3), and Shiqizhui (EX-B7). After having identified the syndrome of a patient, we followed the treatment principles of covering the affected area and using as few acupoints along the meridians as possible to select points along the governor vessel in the affected segment; points along the affected meridians refer to points along the meridians in the region of the lower limbs, in which pain and discomfort were localized. We often used points along the bladder, gallbladder, and stomach meridians, including Huantiao (GB30), Yanglingquan (GB34), Weizhong (BL40), Feiyang (BL58), Xuanzhong (GB39), Zusanli (ST36), and Sanyinjiao (SP6). After having identified the syndrome of a patient, we followed the treatment principles of covering the affected area and using as few points along the meridians as possible to select points along the meridians in the affected segment.In addition, we used two acupoint selection methods to reinforce qi and blood and promote their circulation. To be specific, for reinforcement, we often selected Zhongwan (CV12), Xiawan (CV10), Qihai (CV6), Guanyuan (CV4), Zhongji (CV3), Daheng (SP15), and Tianshu (ST25). If the low back pain was referred to the hip joints, we added Wailing (ST26) to the affected side. If the pain was referred to the knees and legs, we added Zusanli (ST36) and Dubi (ST35) to the affected side. If the kidney yang of a patient was deficient, we added Dahe (KI 12), and if a patient had pain along the sides of their spine, we added points along the kidney meridian on the abdomen.For promoting circulation, we often punctured Ashi points in the painful area. We applied the fire needling therapy to disperse subcutaneous nodules and cysts in the lumbus. If there was obstruction in meridians and collaterals, we applied the bloodletting cupping therapy. We applied warming needle moxibustion or fire needling to treat regional cold pain. In terms of regional cold pain and dampness, we used warming needle moxibustion or moxibustion. To remove qi stagnation and blood stasis, we often selected the shu points of five-shu points along hand yang meridians on the distal side of the hand and sometimes asked our patients to move during acupuncture.If a patient's pain was mainly caused by the excess syndrome, we used, primarily, acupuncture on points on their back and then, to a lesser extent, on points on their abdomen.On the other hand, if a patient's pain was mainly caused by the deficiency syndrome, we used, primarily, acupuncture on points on their abdomen and then, to a lesser extent, on points on their back.If a patient had a local pain point, cold spot, cyst, steak, or blue vein on their back, we appropriately applied bloodletting and cupping therapy, fire needling therapy, warming needle moxibustion, or moxibustion and then, to a lesser extent, used acupuncture with filiform needles on points on their abdomen or back to regulate the circulation of their qi.During consolidation treatment, we used, primarily, acupuncture on points on the abdomen and then, to a lesser extent, on points on their back.Our patients had treatment 2 or 3 times a week until the pain was remarkably relieved, followed by 3 to 6 times of consolidation treatment.We collected our data before and after the treatment using the Visual Analogue Scale (VAS) and the Oswestry Disability Index (ODI).p-value was 0.05 or lower, the observed differences were considered statistically significant.We carried out a two-tailed hypothesis test to analyze our data. We set our alpha to 0.05, so if the t-test  and the Wilcoxon signed rank-sum test .When we performed the descriptive statistics, we used measures including the mean, standard deviation, median, minimum and maximum variables, and interquartile range (Q3-Q1). In addition, our enumeration data were composed of categorical variables such as the age ratio and the percentage of patients with distending pain. When we compared the data collected before and after treatment, we used the paired In our real-world study, our twenty-four patients completed their treatment as required. We collected the data before and after the treatment using the VAS and the ODI. Then, we performed descriptive statistics, and our results had statistical significance. The descriptive statistics of the treatment period, treatment time, onset time, and improvement time are shown in P < 0.0001). The VAS pain scores after treatment were significantly lower than those before treatment (see P < 0.0001). The ODI scores after treatment were significantly lower than those before treatment , Huaroumen (ST24), Wailing (ST26), Shuidao (ST28), Guilai (ST29), and Zusanli (ST36) in the stomach meridian of foot-yangming and Daheng (SP15) and Sanyinjiao (SP6) in the spleen meridian of foot-taiyin, can tonify Qi and blood, invigorate the spleen and stomach, and improve the function of the low back and knees. Strengthening the middle and lower jiao can promote blood circulation on the low back and abdomen. Qi circulates between the conception vessel and the governor vessel. Acupuncture on Zhongwan (CV12), Xiawan (CV13), Yinjiao (CV7), Qihai (CV6), and Guanyuan (CV4) can tonify the liver and kidney and enhance Qi. Therefore, the principle of conducting yang from yin can be followed to effectively treat the pain on the governor vessel at the center of the spine. The urinary bladder meridian is a main meridian in the low back. Zhongji (CV3) is the alarm point of the urinary bladder. The lumbus is the house of the kidney, so puncturing points on the urinary bladder meridian such as Huangshu (KI16), Qixue (KI13), Dahe (KI12), and Henggu (KI11) can tonify the kidney qi. Therefore, puncturing these points appropriately can help treat CLBP.When applying abdominal acupuncture to treat CLBP, we should initially puncture the points for conducting qi back to its origin, namely, Zhongwan (CV12), Xiawan (CV13), Qihai (CV6), and Guanyuan (CV4), and appropriately add one or more acupoints including Daheng (SP15), Wailing (ST26), Guilai (ST29), Shuidao (ST29), and Zhongji (CV3). This treatment strategy corresponds to the traditional principle of using acupuncture for tonifying the kidney, spleen, and governor vessel and that of conducting yang from yin. Besides, this treatment can effectively handle the problem with the consumption and can thereby achieve great overall treatment effectiveness.During treatment, we can alternate puncturing points on the abdomen with puncturing points on the back. In addition, we should determine the order of acupuncture on the abdomen and back based on the state of increase and decrease between excess and deficiency.According to Zhongshi (Lingshu), the prerequisite for treating a disease is to find its causes. Since CLBP recurrence or aggravation normally has clear inducing factors, we should remove the factors before carrying out routine treatment. For example, if external wind and cold lead to CLBP recurrence or aggravation, we should initially puncture Hegu (LI4), Fengchi (GB20), and Weizhong (UB40). If the inducing factor is sprain, we should appropriately puncture Ganshu (UB18), Geshu (UB17), Hegu (LI4), and Taichong (LR3) in the first place. To eliminate emotional factors, first, we should appropriately puncture Baihui (GV20), Shenmen (HT7), Neiguan (PC6), and Taichong (LR3). After removing the inducing factors, we can apply the three-edged needle or fire needle therapy to carry out routine treatment for patients who have good constitutions and symptoms in their low back, for example, fixed tender points, dull purplish spots, nodules, or cysts. By using these two therapies, blood can be activated to remove stasis and collaterals can be unblocked to dissolve nodules. Then we should puncture points on the abdomen or low back to strengthen healthy qi.Normally, the pathogenesis of refractory CLBP is deficient and excess in complexity; moreover, the deficiency of healthy qi is dominant. Based on the TCM theories that a disease should be treated from its root and that a prolonged disease results in deficiency and stagnation, we should initially reinforce the healthy one to eliminate the pathogens. In other words, we should initially puncture tonic points on the abdomen and sometimes add moxibustion simultaneously. When the pain has been partially relieved and the healthy qi is supplemented to a certain extent, we should puncture points on the low back to promote the circulation of qi and blood to further relieve the pain. This treatment strategy conforms to the TCM treatment theory that unblocking obstruction to qi circulation is key to pain relief.The filiform needle therapy is widely used in clinical practice to regulate the flow of qi. However, existence of qi is a prerequisite for such treatment. Merely using the filiform needle therapy to treat patients with deficiency of qi, yang, or essence produces the paradoxical effect since no qi can be regulated; instead, healthy qi is consumed. Consequently, the pain still exists after prolonged treatment. Therefore, we should treat CLBP based on the TCM therapeutic principle of observing the pulse and syndromes to treat the disease. For example, if the pain is caused by qi stagnation and blood stasis or if the lumbar function is reduced due to pain, we can use the therapy of acupuncture combined with movement to promote the circulation of qi and activate blood to unblock collaterals. For patients with the deficiency syndrome, we can combine the filiform needle therapy with prescription of Chinese medicine and moxibustion on tonic points on the abdomen. However, selection of tonic points on the abdomen is often disregarded by many practitioners providing clinical treatment.In line with the TCM theory of chronic diseases transforming to collaterals and causing stagnation, the syndrome of excess resulting from deficiency is common in CLBP. The typical signs are dull purplish spots, red and swollen patches, and musculotendinous nodules, in which the pain exists. Under such circumstances, it is not legitimate to merely use the filiform needle therapy. Therefore, we should combine the filiform needle therapy with other acupuncture techniques. Specifically, we can add the fire needling, round sharp needle, or blade needle therapy to disperse the musculotendinous nodules. In order to dissolve the dull purplish spots and red and swollen patches, we can add the bloodletting therapy to activate blood to dispel stasis and purge fire to relieve swelling. However, since most of these acupuncture therapies are a reducing method, we want to emphasize the importance of using the fire needling therapy because, as a therapeutic principle of simultaneous elimination and reinforcement, it can produce optimum effects on warming and unblocking meridians by dissipating nodules, dispelling blood stasis, expelling cold and dampness, warming yang, and replenishing qi.Moxibustion can reinforce healthy qi and warm and unblock meridians. Using moxa on a larger area of interest, for example, using moxa along the governor vessel or putting a big moxa box on the painful area, invigorates yang qi and warms and disperses cold-dampness. On the other hand, using direct moxibustion or thermal-sensitive moxibustion on a small and specific area of interest can conduct the flow of meridian qi better. In other words, it can promote transmission sensation along meridians and collaterals to the location of the pain better, and thus, the effect of moxibustion can act better on the affected area. Suspended moxibustion and warming needle moxibustion are preferable to patients with consumption since the way to burn moxa in these two therapies creates mild heat in a gradual way, which accords with the TCM theory of mild fire supplementing qi.Using acupuncture on extremely weak patients is contraindicated; instead, medication and moxibustion are preferable. Chapter 4 of Lingshu's Miraculous Pivot recommends that people who suffer from yin, yang, or qi deficiency or those who have a weak constitution be prescribed Chinese medicine rather than treated with acupuncture. Accordingly, patients who are elderly, have a weak constitution, suffer from osteoporosis, or whose pain has been relieved to the extent that they have progressed to the lumbar functional recovery phase should be treated with moxibustion and/or prescribed Chinese drugs including Lujiao (Cornu Cervi), jinmaogouji (Cibotium Barometz), shengduzhong (Cortex Eucommiae), xuduan (Radix Dipsaci), sangjisheng (Ramulus Loranthi), tusizi (Semen Cuscutae), gusuibu (Rhizoma Drynariae), jixueteng (Caulis Spatholobi), weilingxian (Radix Clematidis), shengbaizhu , and laoguancao (Herba Erodii Seu Geranii). These Chinese drugs can tonify the kidney essence, activate blood to unlock collaterals, and strengthen the spleen to disperse dampness.This study has proven that our research approach accords with the TCM theories of individual treatment and syndrome differentiation. In light of the CLBP pathogenesis of deficiency and excess in complexity, especially the complicated pathogenesis of refractory CLBP, the aforementioned acupuncture-moxibustion therapies should be applied appropriately according to each patient's unique pathogenesis. Before applying the reinforcing and circulation-promoting protocol of acupuncture and moxibustion to treat refractory CLBP, we should identify the pathogenesis based on syndrome differentiation. Besides, during treatment, we should give great importance to the therapeutic principle of reinforcing healthy qi and tonifying deficiency. In addition, when the pain has been relieved in a short term, the treatment should not be discontinued. Instead, we should continue to carry out consolidation treatment to reduce the recurrence rate and maintain the efficacy over long periods. However, this study could have been more fruitful if we had invited more patients.