Objective: To examine whether joint management of cancer pain by physicians and pharmacists in clinics provides economic advantages from the perspective of the Chinese healthcare system.Methods: From February 2018 to March 2020, 100 patients who visited the joint cancer pain clinic at the Xiangya Hospital of Central South University were included. These patients were randomly assigned to either the control or intervention groups. The control group received regular outpatient services from a physician, while the intervention group received regular outpatient services from a physician and medication education provided by a pharmacist. The study considered various direct costs, including drug expenses, physician-pharmacist outpatient services, adverse event management, consultations, examinations, and readmissions. The outcome indicators considered were the cancer pain control rate and the reduction in pain scores. Decision tree modeling, single-factor sensitivity analysis, and probabilistic sensitivity analysis were performed to evaluate the cost-effectiveness of joint physician-pharmacist outpatient services compared to physician-alone outpatient services.Results: The intervention group showed a significantly higher cancer pain control rate than the control group . In the decision tree model, the intervention group had a significantly lower pain score than the control group (0.23 vs. 0.14). The cost per person in the intervention group was $165.39, while it was $191.1 per person in the control group. The univariate sensitivity analysis showed that the cost of self-management for patients in the control group was identified as the primary sensitivity factor. Probabilistic sensitivity analysis indicated that the joint clinic group had a favorable incremental cost-effectiveness compared to the physician clinic group. In addition, the probabilistic sensitivity analysis demonstrated an absolute advantage in the incremental cost-effectiveness of the joint clinic group over the outpatient physician group.Conclusion: The participation of pharmacists in joint cancer pain clinic services led to improved pain management for patients, demonstrating a clear advantage in terms of cost-effectiveness. Pain is closely associated with cancer and is a significant diagnostic factor . The gloBased on a comprehensive literature review over the last 40 years, 64% of patients with advanced or metastatic cancer experience pain, rising to 59% among those undergoing anticancer treatment. Furthermore, one-third of patients experience pain after achieving a tumor cure . Cancer The management of cancer pain is a complex task due to various factors. These include the intricate evaluation of cancer pain medications, substantial differences in drug tolerance among individuals, and the necessity for precise dose titration . FurtherClinical studies have highlighted the valuable contribution of clinical pharmacists to improving pain outcomes through enhanced communication, pain assessment, and patient education . RecogniThe cost-effectiveness of pharmacists in cancer pain management within the Chinese healthcare system is uncertain. Therefore, this study aimed to assess the cost-effectiveness of integrating pharmacists into the team responsible for managing cancer pain.Chictr.org with the registration number ChiCTR1900023075  18 years or older, 2) diagnosed with malignant tumors confirmed by pathological or cytological methods, 3) experienced cancer-related pain that met the diagnostic criteria for cancer pain outlined in the National Comprehensive Cancer Network (NCCN) guidelines and was categorized as moderate to severe , 4) capable of reading and using WeChat  by the patient or family members, 5) possessed the normal verbal ability and performance status, and 6) provided a voluntary agreement to participate in the study and signed the informed consent form.Perspective and interventions/comparator: only the medical costs incurred within the hospital were considered. The study investigated the economic viability of incorporating pharmacy services in the given context. The subjects were divided into two groups: the intervention group, which received interventions from physicians and pharmacists, and the control group, which received interventions solely from physicians.Care of patients in the intervention group: each day, the pharmacist collected and recorded data in the 24-h pain diary, documenting patients’ pain levels and any related observations. Every 3 days, the pharmacist also completed adverse drug reaction (ADR) forms, noting any adverse effects experienced by the patients. Additionally, every 15 days, the pharmacist administered a Brief Pain Inventory (BPI) form to assess pain intensity and its impact on the patient’s daily life. Based on this comprehensive review, the pharmacist proposed appropriate pharmacological interventions to the attending physician if a change in medication, dosage, or treatment of an ADR was necessary. The physician was responsible for prescribing or adjusting the patients’ pain medications based on the pharmacist’s recommendations. In the cases where no changes were required, the pharmacist provided targeted education to address any knowledge deficits identified in the patients.Care of the patients in the control group: the patients in the control group received conventional care. Before discharge, the pharmacist provided detailed medication education to ensure that patients understood their prescribed medications well. However, unlike the intervention group, the control group received no specific reminders or prompts to complete the forms mentioned earlier.The time horizon was determined based on several factors. According to the NCCN guidelines, aiming to effectively control cancer pain within 24 h is recommended, with ideally completed opioid titration within 3 days. Considering patient adherence and cost measurement, the study duration was set at 4 weeks. Given the relatively short period of the study, we did not consider a discount rate.Outcome evaluation: the primary outcomes were pain intensity and cancer-related pain control rate, while the secondary outcomes examined ADRs and readmission rates.The NRS score of a cancer patient <4 indicates that the patient has effectively controlled cancer pain. The calculation for the control of cancer pain rate is as follows: Control of cancer pain rate =  * 100%.Healthcare expenditure involved various elements, including expenses related to cancer pain treatment drugs, ADR treatment, laboratory tests, physician-pharmacist service fees, and pharmacist service fees. The cost of medications was derived from the 2018 Central South University Xiangya Hospital procurement system, accounting for the consultation and laboratory test fees. The expenses of pharmacist follow-up were calculated based on the average salary of pharmacists at the Xiangya Hospital of Central South University. The follow-up duration was determined using a median follow-up time of 10 min, costing $2.1 per session. Additionally, the pharmacist provided patient information and utilized the WeChat remote guidance service, which incurred charges equivalent to fees set by the Internet Clinic at the hospital, amounting to USD 1.479 per session. Details are shown in When prescribed drugs did not effectively control patients’ pain, they could either be readmitted to the hospital or contact the pharmacist for assistance. Through pharmacy services, the pharmacist focused on enhancing patient adherence and addressing any ADR using WeChat as a communication platform. The calculations were based on the hospital Internet outpatient charges to determine the costs involved. The readmission fees were obtained from the patient discharge invoice data.The effectiveness of the treatment was evaluated based on the reduction in the NRS score. An NRS score less than 4 at the final follow-up was considered effective, and treatment efficiency was estimated separately for each scenario. When comparing the two groups’ efficiency, the least-cost analysis method was utilized if the difference was statistically significant. If the difference was statistically significant, a cost-effectiveness analysis was performed. A decision-tree model was established to guide the study. A decrease in the NRS score indicated effective treatment and was assigned a value of 1, while an increase or no change in the NRS score indicated ineffective treatment and was assigned a value of 0. The treatment efficiency was then calculated for each scenario by dividing the number of effective cases by the total number of patients in the group.When assessing multiple programs, a comparison was made between the costs and effects of two intervention programs. If one program demonstrated a higher effect and a lower cost than the other, it indicated a clear advantage in achieving a greater effect at a lower cost.We conducted a one-factor sensitivity analysis to examine the impact of varying each state parameter within its designated range of values on the study outcomes. The medication cost was considered, with upper and lower limits representing the actual costs incurred by the patients. A range of probabilities was applied, with values set 20% higher or lower than the base value. The results of the single-factor sensitivity analysis were presented in the form of a cyclone diagram. We performed a probabilistic sensitivity analysis to further explore the impact of each state parameter on the study outcomes. This analysis involved randomizing each parameter according to its distribution pattern. The Monte Carlo simulation method was used, repeating the extraction simulation 10,000 times. The cost followed a Gamma distribution, while the effect and transfer probability followed a Beta distribution. The results of the probabilistic sensitivity analysis were presented in the form of cost-effectiveness acceptability curves and scatter plots on the cost-effectiveness plane, as detailed in In the intervention group, cancer-related pain control rates, incidence of ADRs, and adherence with the prescribed intervention were significantly higher compared to the control group, with statistically significant differences . HoweverCost-effectiveness analysis involves quantifying the monetary cost of an alternative concerning its associated benefits, which are expressed as clinical outcome indicators. After calculating the costs using the model, the intervention group had a cost of $165.39 and an effect of 22.62%. In contrast, the control group had a cost of $191.1 and an effect of 13.87%. This analysis shows that the intervention group had lower costs and achieved better outcomes, making it more cost-effective .A univariate sensitivity analysis was conducted on medical costs, treatment efficiency, adverse effect control, and readmission rates. The analysis revealed that the most influential factors affecting the outcome were the costs associated with readmission from control patients and the costs related to self-management by control patients. These findings are visually presented in a cyclone diagram depicted in A planar scatter plot of incremental cost-effectiveness was generated by performing 10,000 repetitions of the simulation using Monte Carlo simulation. The economic analysis of the physician-pharmacist group was performed by plotting a cost-utility acceptability curve. In According to the latest data from CANCER TODAY , the totMorbidity and mortality rates in patients with advanced cancer remain persistently high. However, the availability of a broader range of treatment options for advanced cancer has led to improved treatment efficacy. In particular, the 5-year survival rate among patients with advanced cancer has increased significantly, resulting in a notable increase in patients living with tumors for extended periods. Despite these advances, advanced cancer patients frequently experience pain requiring opioid analgesics . CurrentAlthough comprehensive and multifaceted education has shown the potential to improve patient outcomes in cancer pain treatment, it simultaneously increases the financial burden on patients. In the management of opioids, pharmacists play a crucial role, including tasks such as pain assessment, suggesting adjustments to treatment protocols, identifying medication-related issues, guiding medication use, patient follow-up, and monitoring ADRs. Assessing the economic viability of involving pharmacists in cancer pain management is essential to determine its cost-effectiveness. This study analyzed the cost-effectiveness of joint outpatient physician-pharmacist management compared to outpatient physician management of cancer pain from the perspective of the Chinese healthcare system.In the base analysis, the physician-pharmacist group demonstrated enhanced patient adherence and improved cancer pain control, even with the additional cost of pharmacist services. Decision-tree model analysis overwhelmingly supported the physician-pharmacist group as the superior option for managing cancer pain. During the univariate sensitivity analysis, the costs associated with the readmission of control group patients to the hospital emerged as the most influential factor, followed by the costs incurred by patients in self-management.A previous study  demonstrIn this study, the incidence of ADRs was higher in the intervention group compared to the control group. This difference could be attributed to the intervention group’s proactive approach, which used WeChat to report ADRs every 3 days immediately. This regular reporting helped mitigate bias caused by forgetfulness. In contrast, the control group patients were only seen once every 2 weeks, and they often forgot to report ADRs in the absence of reminders, resulting in potential data loss. Patient awareness of ADRs is generally low. In the intervention group, pharmacists actively educated patients about medication use, making them aware of possible ADRs that might occur during treatment. For example, if a patient in the intervention group experienced dizziness, they were encouraged to complete the ADR registry. Patients in the control group often attributed such symptoms to the disease and did not inform physicians during outpatient follow-up visits. This study relied primarily on a randomized controlled trial conducted by the subject group to ensure that the data source was first-hand and reliable. The treatment effectiveness rate at each decision point served as an effect parameter, while the medical expenses incurred by the patients were considered costs. A comprehensive evaluation of the interventions’ cost-effectiveness was performed by calculating the ICER.This study has some limitations. First, the sample size was relatively small, which could limit the generalizability of the findings and the statistical power of the analysis. Second, the data source was derived from a single center, specifically a large tertiary care hospital in China, which may not fully represent the experiences and practices of hospitals at different levels and in other countries. Third, the follow-up duration was relatively short, as cancer pain studies have reported mean survival times of 318 days . FurtherManaging cancer pain patients through physician-pharmacist joint clinics is more effective and cost-effective than general physician office visits. This finding highlights the potential advantages and benefits of integrating pharmacists into the care team for managing cancer pain. The physician-pharmacist collaboration can contribute to improved patient outcomes and better utilization of healthcare resources, making it a favorable option for cost-effectiveness.


To present the functional outcomes, through the first case series in our country, of patients with thoracolumbar burst fractures , submitted to short posterior fixation, without arthrodesis and without removal of the implants, until the end of the minimum follow-up of one year.Fifty five patients consecutively treated between January/2010 and January/2019 were evaluated through medical records and imaging exams. Radiographic analysis was performed by mea suring local and segmental kyphosis using the Cobb method. Functional assessment was analyzed using the non-specific SF-36 questionnaire and the 1983 Denis pain and work-specific questionnaire, applied after 12 months of follow-up.With a loss of five patients (9%), 22 (44%) patients reported having minimal and occasional pain and 8 (16%) patients reported having no pain. Three (6%) patients responded that they were completely incapacitated. Patients had a mean score of 73.16 points in the SF-36 domains. There was a significant reduction in kyphosis in 12 months (9.1±5.2 [min-max 0-22]) compared to the preoperative period (14.9±7.8 [min-max 0-32]) ( p≤0.01). One patient required implant removal due to the symptomatic prominence of the implant.Evidence Level IV; Case series.This case series suggests that the technique leads to satisfactory functional results, without implant failure or significant kyphosis after a minimum follow-up of 12 months of treatment.  The thoracolumbar transition is most affected by fractures of the spine as it is a region located between the less flexible thoracic spine and the more flexible lumbar spine. Studies show that the short posterior fixation with screws in the fracture is enough to obtain stability, avoiding the need for instrumented fusion of the long segment. However, there still seems to be no consensus regarding the long-term results.Burst fractures are one of the most common types of fractures of the thoracolumbar spine, mainly caused by trauma mechanisms in the axial direction, ranging from 21 to 64% of all thoracolumbar fractures. long or short fixation, with or without intermediate screw.Despite the development of biomechanical studies and new instrumentation systems, clinical studies still discuss the most appropriate surgical procedure to treat burst fractures since ventral, dorsal and combined instrumentation are available, In view of the lack of consensus and the scarcity of studies on fixation without arthrodesis and without removing implants in our country, we proposed a series of cases with short fixation without arthrodesis to analyze the clinical and radiographic outcomes, with a minimum follow-up of one year.Furthermore, the fusion or arthrodesis of the fixed segment may or may not be performed, even if there are studies that demonstrate that there is no clinical and radiographic difference in the results.Therefore, the aim of this study was to analyze the functional and radiographic outcomes of patients with thoracolumbar burst fractures according to AO (A3/A4), treated with short fixation via the posterior approach, without arthrodesis and without removal of the implants until the end of the minimum follow-up of 12 months.This study was approved by the Research Ethics Committee of Santa Casa de São Paulo, under protocol number 2.573.255, and by the Management Committee for Internships, Projects, Research, Extensions and Work–CGEPET, from the Dourados Health Services Foundation – FUNSAUD, by letter of authorization. All patients included in this study read and signed an informed consent form. Of a total of 55 patients, five lost follow-up during follow-up. Therefore, 50 patients completed the study . The mean follow-up period for patients was 14.5±12.4 months (ranging from 12 to 60 months). Patients without neurological deficit underwent short posterior fixation, without arthrodesis, with a screw in the fractured vertebra, according to the technique described by Kanna et al.This study is a retrospective analysis of consecutive case series, using medical records and imaging exams (x-ray [XR] and computed tomography [CT]), with data from pre- and postoperative assessments of patients with thoracolumbar burst fractures type A3 and A4, according to the AOSpine classification.Inclusion criteria were: thoracolumbar burst fractures classified as A3 and A4 by AOSpine, without neurological deficit, acute, which underwent surgical treatment with short fixation, including the fractured vertebra, without arthrodesis.Exclusion criteria were: multiple-level fractures, fractures caused by other diseases, fractures not classified as A3 or A4, cases with arthrodesis or with a larger fixed segment, patients with neurological deficit, patients with less than one year of follow-up, incomplete medical record, lack of radiographs at the beginning and end of follow-up, loss of follow-up or non-acceptance to participate in the study.The variables studied were age, gender, level affected, pre- and postoperative Cobb angles (1948) and neurological status according to the Scale by Frankel et al (1969). The patients underwent functional analysis based on the Denis Pain and Work Scale and the Short–Form 36 (SF-36) quality of life questionnaire applied at the last follow-up.The primary functional outcomes evaluated in this study were pain and postoperative functional capacity, according to the criteria of Denis (1983). As a secondary outcome, quality of life was assessed according to the SF-36 validated for the Portuguese language. To measure the segmental kyphosis (fixed segment), immediately preserved endplates, cranial and caudal at the affected level were used as reference. For local kyphosis (fractured vertebra), the end plates of the upper and lower fractured vertebrae were used for the measurement , in the immediate postoperative period (immediate) and at the end of the 12-month follow-up.Radiographic analysis was performed by measuring local and segmental kyphosis using the Cobb method.surement , accordi we started with the classic posterior exposure of the spine through the midline. The posterior ligament complex and the facet joint were preserved during the exposure.With the patients under general anesthesia and positioned in the prone position, a standard posterior midline incision was made. Using the technique of Kanna et al, We used intraoperative radioscopy and polyaxial screws in all procedures. The placement of screws in the vertebrae above and below the fracture was started, with divergent inclination , at the junction point of the transverse process and upper facet with a pointed perforator.lination , so that Thus, the reduction procedure included the following steps: improvement of the local and segmental kyphosis, lordotic distraction to reduce the vertebral height and the intra-canal fragment, and rigid block with the placement of counter screws. The implants, in theory, should be removed after radiographic consolidation, which occurs on average six months after the fracture.Through the ligamentotaxis mechanism, the reduction and decompression of the vertebral canal was carried out indirectly.For the final analysis of the data, descriptive statistics  were used.To determine the normality of the sample, we used the Shapiro-Wilk test. As most of the variables did not have a normal distribution, non-parametric tests were chosen.To compare the segmental and local kyphosis angles, the Friedman's non-parametric test was used. For comparison between the evaluated moments, the Wilcoxon test was applied. For the correlation between the Denis Pain and Work Scale scores and the SF-36 quality of life questionnaire, Spearman's correlation test was used.The SPSS version 13.0 program was used to perform the statistical analysis of this work. The significance value was set at p≤0.05.Following the criteria for inclusion of fractures, 39 cases were classified as type A3 (78%) and 11 cases were classified as type A4 (22%).On the Denis Pain Scale, 22 patients (44%) reported minimal and occasional pain. Moderate pain was reported by 20 (40%) patients, but without interruption of daily activities or work. Other patients (16%) responded that they were without pain after one year of follow-up. On the Denis Work Scale, 24 patients (48%) responded that they would be able to return to work (sedentary) or heavy work with restrictions. In addition to these, 12 (24%) patients responded that they felt able to return to previous work (heavy) or heavy physical activities. However, 11 (22%) patients reported that they felt unable to return to their previous job but were working full time in a new job, and only three (6%) patients responded that they were completely disabled. The analysis of segmental kyphosis showed a statistical difference between the evaluated moments (p≤0.01). There was a smaller angle of segmental kyphosis in the immediate post-surgical moment (11.5±8.7 [min-max 0-31]) compared to the baseline moment (13.3±8.5 [min-max 0] -40]) and 12 months (13.2±7.8 [min-max 2-36]) p≤0.01, .The analysis of local kyphosis showed a statistical difference between the moments (p≤0.01), with a significant reduction in the angulation in the immediate postoperative period (8.8±5.4 [minmax 1-22]) and 12 months ( 9.1±5.2 [min-max 0-22]) compared to baseline (14.9±7.8 [min-max 0-32]) p≤0.01, .One patient underwent removal of the synthesis due to pain and local discomfort in the prominence of the implant and reported, after three months of removal of the synthesis, an improvement in local pain and movement.There were no cases of infection, implant failure, neurological deficit, or significant loss of correction until the end of follow-up.At the end of 12-month follow-up, patients scored above 70 in all SF-36 domains, with the exception of physical limitation (48.5±38.3) and pain (69.8±14). Correlation tests demonstrated an inverse relationship between the Denis Pain and Work Scale scores and many SF-36 domains. Regarding the eight domains evaluated in the SF-36 , signifi According to Rometsch et al., although previous studies have shown a possible benefit of surgical treatment for fractures of types A3 and A4, there is no consensus. However, it is still difficult to discuss parts of these outcomes due to the great variability of measurement techniques. Furthermore, most studies do not differentiate fractures into incomplete (A3) and complete (A4).Few studies have compared different treatments in a target population with neurologically intact A3 and A4 fractures. reported that short fixation had better clinical results and faster fusion despite the loss of the final postoperative kyphosis. The studies corroborate our findings, whose segmental kyphosis decreased soon after surgery, despite the return to baseline values after 12 months.  In the study by Chou et al., the loss of segmental kyphosis was attributed to the loss of height of the injured intervertebral disc and not the progression of kyphosis in the fracture. These findings corroborate the results of this study, as local kyphosis remained practically stable for up to 12 months. Furthermore, despite the small loss in the final segmental kyphosis, there was no compromise in the clinical and functional results.In this study, it was shown that after one year of follow-up, 84% of patients reported mild and moderate pain, and 72% said they would return to work despite the small loss of the final segmental kyphosis. Recently, Özbek et al. However, few studies have described the surgical treatment of thoracolumbar burst fractures using the posterior short fixation technique, including the fractured vertebra and without arthrodesis. Our study adds information on outcomes without removing the synthesis material, which is routinely recommended for this technique after fracture healing. In our environment, it is argued that the vast majority of spinal surgery services do not follow the recommendation for removal of implants. The main reasons are the logistical difficulty for an elective vacancy and the non-adherence of the indication for removal of implants in asymptomatic patients. The observation of our patients showed that even without the removal of the implant in 49 patients, there was no case of infection, implant failure, neurological deficit or loss of the final significant correction until the end of follow-up.By analyzing the literature, studies have shown that there is no significant difference between treatments, with and without arthrodesis, after fixation of burst fractures with pedicle screws. Furthermore, Kanna et al., in a retrospective analysis, were also not limited to fractures in A3 and A4, including patients with neurological deficit.Wang et al. reported satisfactory results without fusion. However, the authors did not classify fractures as A3 and A4. Finally, Liao and Fan described a group of patients with type A3 fractures, operated with short fixation, including the fractured vertebra and without arthrodesis, as in our study, but they did not include type A4 fractures, as we did. As in this study, the final clinical results were evaluated by the Denis Pain and Work Scales, in addition to the kyphotic angle by the Cobb method. The mean pain and work score was 1.5 ± 0.8 and 1 .7 ± 0.9, respectively. Segmental kyphosis significantly reduced after surgery, with little loss at the end of follow-up. Regarding the results of the Denis pain questionnaire, it was found that patients answered D1 (no pain), D2  and D3 (moderate) scores, characterizing lesser complaints. The results are supported by the studies by Zhao et al. and Liao and Fan. When making the same comparison with Denis’ work questionnaire scores, a pattern similar to those cited by Liao and Fan was observed, characterizing better ability to return to previous work. When comparing the quality of life results of our operated patients, after 12 months of follow-up, with the results of Laguardia et al., from the normal population, better results were observed after surgery, suggesting a significant improvement in pain and mobility. This demonstrates the assumption that the surgical procedure described was little disabling from a physical point of view.Reinforcing our results, Zhao et al. reported that the technique with intermediate screws can prevent the loss of postoperative kyphosis in patients without neurological deficit, as demonstrated here.Finally, this study has some methodological limitations. First, lack of a control group. Second, a greater number of assessments at baseline and postoperatively would allow for a more accurate comparison of patients’ functional status and quality of life. Third, the follow-up period of just 12 months. And, finally, the fact that the evaluations were not applied blindly by the evaluator.Short fixation without arthrodesis and without removal of the implant via the posterior route of A3 and A4 burst-type thoracolumbar spine fractures seems to be an efficient method for spinal stabilization, enabling satisfactory clinical and radiographic results after a minimum follow-up of 12 months.


The aim of this study is to identify the characteristics of patients who underwent yoga therapy for pain in yoga and naturopathy clinical settings in India.Electronic medical records of patients who received yoga therapy for pain in three inpatient yoga and naturopathy hospitals were reviewed retrospectively from January 2021 to September 2022. Demographic characteristics and details on pain condition, socioeconomic status, comorbidities, ancillary therapies received, and insurance status were collected. In addition, we prospectively collected data on adherence to yoga practice through a telephonic interview.p < 0.001). Adherence to yoga was significantly associated with underlying pain conditions, the presence of comorbidities, the types of therapies used, and socioeconomic status (p < 0.001).A total of 984 patients were identified from a pool of 3,164 patients who received yoga therapy for pain for an average of 9.48 (1.13) days. Patients aged between 8 and 80 underwent therapy for varying pain conditions and diseases that include pain in the extremities, pain due to infection, trauma, degenerative diseases, autoimmune diseases, and spine and neurological diseases. The majority of the patients were females (66.3%), from middle class families (74.8%), and who did not have any insurance coverage (93.8%). Most of the patients were under naturopathy treatment (99.8%), followed by ayurveda (56%), and physiotherapy (49.3%), along with yoga therapy. All patients reported a significant reduction in pain post-integrated yoga therapy (This study highlights the real-time application of yoga in pain management in Indian yoga and naturopathy settings, as well as implications for future research. This surge in the acceptability of yoga has made it one of the most prominently used complementary medicine therapies for various medical conditions . EvidencUnderstanding the characteristics, socioeconomic background, and duration of illness of patients who use yoga as a therapy will provide useful insights that may aid in devising public health policies. While the beneficial effect of yoga in managing psychological and metabolic conditions is well known, there is a growing interest in using yoga for pain management as well , 4. HoweIn India, yoga and naturopathy are regarded among the official indigenous systems of medicine under the Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homoeopathy (AYUSH), Government of India . In IndiThere are approximately 5,000 yoga and naturopathy hospitals in India  that use2.2.1.This study used a cross-sectional study design. The medical records of patients treated with yoga alone or in combination with other complementary medicine therapies for pain were retrospectively reviewed between January 2021 and September 2022 at three in-patient yoga and naturopathy settings in the north, south, and central parts of India . These hospitals were purposefully selected as they had an average bed occupancy rate of over 60% throughout the year.2.2.The electronic medical records were reviewed to collect data on the patients' sociodemographic characteristics such as age, gender, economic status [computed using the Kuppuswamy scale ], insura2.3.All patients who were treated as inpatients for pain see  exclusiv2.4.n = 6) and were observed only under the category of variable age. We employed the item mean substitution method  were descriptively analyzed using mean and standard deviation. Normality of the pain scores was assessed using the skewness of the scores and Q–Q plots. The pretherapy pain scores had a near normal distribution with a skewness of 0.239. We compared the differences in pre- and post-therapy VAS pain scores across the patient characteristics using linear mixed models (LMMs). The effect size was calculated using ss delta  to measuThe patients were followed up to determine their levels of adherence to yogic practice after discharge. A binary logistic regression analysis was conducted to assess the factors associated with adherence to yoga among the participants. The Hosmer–Lemeshow test was conducted to identify the model fit. Adjusted odds ratios (AORs) and 95% CI for the AORs were computed.2.5.The study was approved by the Institutional Ethics Committee of Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women (F.No:12/SHMCNYS-IEC/P27/2022-23), Prakriti Shakti Clinic of Natural Medicine (CGH-PS/IRB/2022/2), and Morarji Desai Institute of Naturopathy and Yogic Sciences (MDINYS/IEC/2022/P7). All participants signed an informed consent (obtained during their in-patient stay for using their de-identified data for research purposes) form to participate in the study.3.3.1.n = 984) were found to have undergone a yoga therapy session for a pain condition. These 984 patients accounted for the study sample. The study participants included 66.3% (n = 652) females and were primarily in the age group of 34–58 years . All participants enrolled reported suffering from some form of pain, with pain due to spine and neurological conditions being the most prominent (36.2%). Most of the participants (93.8%) who sought yoga therapy were not covered by any insurance policies  reported continuing yoga after being discharged from the facility. Specifically, 39.8% (n = 392) practiced yoga every day of the week, 10.7% (n = 105) practiced yoga thrice a week, and 24.8% (n = 244) practiced yoga up to twice a week. Patients who were suffering from lower extremity pain , those who had NCD multimorbidity , and those who belonged to the middle  and upper  socioeconomic strata had greater odds of adhering to yoga therapy post discharge . This pattern was consistent across the three study settings, and naturopathy was reported as the mostly used therapy, followed by ayurveda. This may be attributed to prescription practice followed at the respective clinical settings. Further, the patients may have co-opted to undergo these therapies because of their comorbid conditions, as an integrated approach is reported to reduce the burden of NCDs –20. The All patients reported a significant reduction in their pain irrespective of their age, clinical condition, NCD status, concomitant therapies used, and insurance status. This observation is consistent with that of other experimental studies reporting yoga to alleviate pain in various conditions –24. We aPatients with multiple NCD conditions were found to adhere more to yogic practice compared with those with a single NCD or no NCD. NCD multimorbidity is associated with significant burden and stress. Yoga integrated with naturopathy is recommended to reduce the burden and associated complications of NCD . An earlSocioeconomic status has emerged as another important factor determining the adherence to yoga after the initial exposure. Confirming the results from earlier studies, our study also found a higher adherence of yoga among patients with a higher socioeconomic status , 27. CorTo our knowledge, this is the first study to report the characteristics of patients using yoga for pain management in Indian clinical settings. However, there are notable limitations in the present study. First, barring one variable on adherence to yoga, the rest of our analyses were based on retrospective medical records from three yoga and naturopathy hospitals from India. Therefore, the results of this study have limited generalizability and may not fully reflect the present scenario. All the three clinical settings studied offers yoga and naturopathy as an integrated therapy; therefore, it is difficult to determine whether the patients enrolled for the program exclusively for yoga or to avail both interventions together.Further, we could not extract any data regarding the type of yoga interventions provided, duration of practice, or the detailed use of other supportive therapies, because a manual extraction of such data was not attempted on the ground that it would be extremely exhaustive to do a manual search owing to the individualistic nature of prescription practice in these settings. This remains one of the significant limitations of this present study. We could not collect any data regarding the characteristics of pain and its impact on patient activities of daily living. Such data may have added more value to the findings of this study.Our study indicates that yoga was used along with other multiple therapies. These insights suggest that future yoga research should use pragmatic designs that can include the common ancillary treatments with yoga therapy, which can offer meaningful results. Nevertheless, such research should at least enquire about the use of additional therapies with yoga, which can strengthen prescription practices. Large-scale observational studies are warranted in the future that can include the factors influencing patients to avail yoga therapy and its diverse prescription practices.5.Yoga therapy is used by patients for managing diverse pain conditions, of which a majority of patients receive yoga therapy for degenerative and autoimmune diseases. Yoga is commonly used as an integrative therapy along with naturopathy, physiotherapy, and ayurveda in clinical settings. The inferences from the present study will help in designing future pragmatic trials in yoga.


Tourniquet pain is the most prominent problem in ankle surgery, and there is no proper method to predict it. It was reported that pain sensitivity questionnaires could evaluate the pain sensitivity of subjects. Its potential to predict tourniquet pain in ankle surgery is constructive and meaningful.One hundred and twenty patients undergoing ankle surgery were included in this study. The pain sensitivity questionnaire (PSQ) and self-rating anxiety scale (SAS) were completed before the operation. The methods included an ultrasound-guided popliteal sciatic, a femoral nerve block, and a proximal thigh tourniquet. The pressure of the tourniquet was set according to the systolic blood pressure (SBP + 100 mmHg). A visual analogue scale (VAS) was used to assess the tourniquet pain. Also, the onset time of tourniquet pain ≥4 VAS units was recorded.r = −0.763, r = −0.731, P < 0.001). The PSQ-total score <6.5 group gave significantly lower ratings for items 3, 4, 14, and 16 in the PSQ survey compared to the PSQ-total score ≥6.5 group (P < 0.05). Patients with high pain sensitivity have a higher need for analgesic drugs (P < 0.001). PSQ-total score ≥6.5 , sex , and age  were risk factors for reporting a tourniquet pain ≥4 VAS units within 30 min.The PSQ-total and PSQ-minor scores were significantly correlated with the onset time when the tourniquet pain ≥4 VAS units (The PSQ score is found to be correlated with intraoperative tourniquet pain. In addition, sex and age also affect the time of having intraoperative tourniquet pain. A proximal thigh tourniquet is often used in foot and ankle surgery to facilitate a bloodless field. With the extended use of a tourniquet, patients often complain of pain and discomfort at the tourniquet site or distal limb . HoweverThis study aims to evaluate the feasibility of the PSQ in predicting tourniquet pain in ankle surgery. Preoperative PSQ evaluation is helpful for guiding the formulation of an anesthesia plan, intervening in advance for predictable pain, and implementing individualized anesthesia management.www.Chictr.org.cn on 9 July 2021 prior to patient recruitment (code: ChiCTR2100048525). The clinical trial was approved by the Medical Research Ethics Committee of the First Affiliated Hospital of the University of Science and Technology of China (ethics: 2020KY). The study was conducted between July 2021 and February 2022. Written informed consent was obtained from all participants. Patients aged ≥18 years with ASA  I and II and scheduled for ankle and calcaneal fracture surgery were recruited. Exclusion criteria were as follows: inability to consent to the study, multiple sclerosis, sensory loss, or other diseases affecting sensory function such as diabetes, receiving major opioids for chronic pain therapy or substance abuse, narcotic-intolerant, hepatic or renal failure, allergy to local anesthetics, pregnancy, and prior surgery in the popliteal fossa.The trial was registered at The day before surgery, all patients were asked to complete the Chinese version of the PSQ , 7 and S2), and noninvasive blood pressure were established. All patients received intravenous dexmedetomidine sulphate 0.5 μg/kg within 15 min. All patients were placed in a lateral decubitus position, with the operated limb on the upper side and the hip and knee slightly bent. The block of the sciatic nerve in the popliteal fossa was performed under sterile conditions by ultrasound guidance . A total of 25 ml of a mixed solution of 0.25% ropivacaine and 1% lidocaine was injected around the sciatic nerve and adequate spread of the drugs around the nerves was monitored. Then, in the supine position, 10 ml of the same solution was injected for the femoral nerve block. In addition, adequate spread of the drug around the nerves was monitored. All blocks were performed by the same anesthesiologist. The level of sensory block was assessed using the ice test in 0–2 scale every 5 min. Sensory block rating: 0 = complete loss of sensation; 1 = hypoesthesia; 2 = feeling normal. Successful surgical block was defined as a grade 0 sensory block within 30 min  inserted into the peripheral vein of the upper limb, and 500 ml sodium acetate Ringer solution was intravenously injected within 30–40 min. The standardized monitoring methods of electrocardiogram (ECG), oxygen saturation  was expressed, and a χ2 test was used. Pearson correlation analysis was used for data conforming. Logistic regression analysis was used to predict the risk factors for reporting tourniquet pain ≥4 VAS units within 30 min. All P-values < 0.05 were considered to be statistically significant.SPSS 26 was used for statistical analysis. Normally distributed continuous variables were expressed as the mean ± SD and compared between groups using a two-sample Student's the remaining 120 patients completed the protocol. The demographic characteristics of patients are listed in A total of 123 patients undergoing ankle and heel fracture surgery were enrolled in the study. Three patients who complained of pain at the moment of skin incision were excluded. Finally, The PSQ-total score of all patients was 5.58 ± 1.44, ranging from 1.9 to 9.1. The number of patients with PSQ-total <6.5 was 80, and the number of other patients was 40. The PSQ-minor score of all patients was 2.42 ± 0.85, ranging from 0.8 to 4.6. The onset time of tourniquet pain ≥4 VAS units was 38 ± 17.3 min. Thirty-nine patients reported tourniquet pain ≥4 VAS units within 30 min, and others reported tourniquet pain 30 min later.r = −0.763, r = −0.731, P < 0.001; The PSQ-total and PSQ-minor scores were found to be significantly correlated with the onset time of tourniquet pain score ≥4 VAS (P < 0.05). The ratio of tourniquet pain VAS ≥ 4 units at 30 min and the total amount of additional remedial sufentanil were significantly greater in the PSQ-total score ≥6.5 group compared with the PSQ-total score <6.5 group (P < 0.05). The number of patients who required general anesthesia was not significantly different between the two groups . The SAS score of all patients was 23 ± 3. Also, no patient was anxious before the surgery.The results of the logistic regression analysis are presented in None of the subjects enrolled in the study had complications or side effects associated with the nerve block or tourniquet-related pain within 48 h after surgery.This study investigated the correlation between the PSQ and tourniquet pain to evaluate whether it could identify patients susceptible to tourniquet pain and provide a basis for improved clinical management through treatment strategies in each patient.We enrolled patients with ankle or heel fractures; thus, the femoral nerve and the sciatic nerve block could meet the analgesia requirement of the procedure. The effectiveness of different approaches to sciatic nerve block in preventing tourniquet pain is controversial. Spasiano et al. reported that the combination of proximal sciatic nerve block with femoral nerve and lateral femoral cutaneous nerve block might greatly suppress thigh pain after tourniquet inflation . In contWe found that both PSQ-total and PSQ-minor scores are negatively correlated with the onset time of tourniquet pain ≥4 VAS units, which means that the PSQ score and its subgroup could predict the tourniquet pain to some extent. In healthy subjects, experimental pain intensity rating scores were more strongly correlated with the PSQ-minor subscore than with the PSQ-total score. Nevertheless, the authors mostly recommend that both the PSQ-total score and the PSQ-minor subscore should be collected , 6. BearAnother finding of our study is that female gender and age, besides PSQ, were all risk factors for the occurrence of tourniquet pain ≥4 VAS units within 30 min. Our results indicated that women might report tourniquet pain earlier than men after the tourniquet is inflated. Population-based pain research has shown that women are more likely than men to report a variable range of temporary and persistent pains and to report more severe pain, more frequent pain, and pain of longer duration than men –21, whicIn this study, we tried to detect whether anxiety was a risk factor for pain sensitivity. Unexpectedly, we found that the SAS scores of all patients were less than 40, which means no patient was anxious before the surgery. Perhaps this was because all the subjects thought the procedure would be safe and were full of confidence about the curative effect.There are some limitations in the present study. We did not measure the thigh circumference and local fat thickness of the tourniquet, which may affect the patient's susceptibility to tourniquet pain.In conclusion, PSQ scores are found to be associated with intraoperative tourniquet pain. In addition, patients with high PSQ scores, women, and younger patients may have an earlier onset of tourniquet pain. Moreover, preoperative PSQ assessment can help guide the development of anesthetic protocols, earlier intervention for predictable pain, and the implementation of individualized anesthetic management.


As with fibromyalgia, several musculoskeletal disorders are characterized by chronic pain, raising a clinical question – do the instruments used to assess fibromyalgia symptoms according to ACR criteria (ACR criteria) generate similar scores in other chronic musculoskeletal pain?To compare the symptoms among fibromyalgia and other chronic musculoskeletal pain. Additionally, we also compared the most researched outcomes in fibromyalgia .A cross-sectional study. Participants over 18 years old were included if they presented report of chronic musculoskeletal pain (≥ 3 months) and after that, they were divided into two groups . They answered the Fibromyalgia Impact Questionnaire-Revised (FIQ-R), Brief Pain Inventory (BPI), Numerical Pain Rating Scale (NPRS) for pain and fatigue, WPI, and SSS.A total of 166 participants were included in this study into two independent groups . We observed significant differences (p < 0.05) and large effect sizes  in clinical outcomes comparisons between groups .Fibromyalgia patients (2016 ACR criteria) compared to other chronic musculoskeletal pain patients have higher levels of pain (at rest or after movement) and fatigue, greater impairment in both functionality and global impact, and worse symptoms. Therefore, the WPI and SSS instruments should be used exclusively to assess fibromyalgia symptoms.The online version contains supplementary material available at 10.1186/s12891-023-06572-x. Fibromyalgia  is a chronic condition characterized by widespread pain and complex symptomatology , such asHowever, although WPI and SSS instruments perform generic assessments of chronic musculoskeletal pain  , it is nThus, the objective of this study was to compare (via WPI and the SSS) the symptoms among fibromyalgia and other chronic musculoskeletal pain. Additionally, we also compared the most researched outcomes in fibromyalgia  and through messaging applications (WhatsApp®). All people who manifested interest in taking part in the study were contacted and checked for eligibility criteria. All those who were included in the study received an online form (via GoogleForms®) and agreed to take part in the study by clicking on the “I agree to take part in the present study” after reading the informed online consent form. All participants received an online booklet with information regarding fibromyalgia / chronic pain after the end of their participation  through G*Power (version 3.1.9.7). We used the effect size of 0.44 [Considering the primary outcome of our study (comparisons between groups), we performed the sample calculation  of 0.44 , 13, alp of 0.44   and after that, they were divided into two groups . For the fibromyalgia group, people should have the fibromyalgia diagnosis , presence of severe comorbidities in the heart, liver, and/or kidney, presence of neoplasia, systemic autoimmune or inflammatory concomitant diseases, hypothyroidism, pregnancy and/or breastfeeding, and presence of therapeutic intervention in the last six months.Participants answered Fibromyalgia Impact Questionnaire-Revised (FIQ-R) , Brief PFIQ-R assesses the impact of fibromyalgia on life in relation to functional capacity, professional status, psychological disorders, and physical symptoms . Its BraWe also use BPI, a self-report instrument validated for the Brazilian population . BPI assWe assess pain intensity using the NPRS, a self-report instrument validated for the Brazilian population . NPRS isThe distribution of variables was verified using Kolmogorov-Smirnov test. We set the significance level at 5% for all statistical tests, which in turn were processed using the Statistical Package for the Social Sciences software, version 17.0 . The comparisons between variables were performed via independent T-test and presented as: mean, standard deviation (SD), mean difference (MD) with confidence interval (95% CI), and effect size , calculaThree hundred and ninety-six women volunteered. After the screening, according to the eligibility criteria mentioned in the methods, a total of 166 participants were included in this study into two independent groups . We observed significant differences (p < 0.05) and large effect sizes  in clinical outcomes comparisons shown in Tables Our study shows large effect sizes, indicating the clinical relevance of the comparisons of the present study. Clinical relevance  indicates that the results of a study are meaningful or not for several stakeholders . The cliThe objective of this study was to compare (via WPI and the SSS) the symptoms among fibromyalgia and other chronic musculoskeletal pain. Additionally, we also compared the most researched outcomes in fibromyalgia , observed in our study, reinforced that the severity of symptoms is greater in fibromyalgia patients. However, although our results support the use of SSS in patients with fibromyalgia, we highlighted that Elkana et al.  found thAlthough patients with fibromyalgia have chronic musculoskeletal pain in different parts of the body , it doeAs clinical applicability to evidence-based practice, we suggest to the health professionals, first of all, screen fibromyalgia using specific instruments . In theAlthough this was the first study to compare fibromyalgia symptoms, according to ACR criteria (WPI + SSS), to scores in other chronic musculoskeletal pain, our study has limitations that must be addressed. Although participants reported pain and global symptoms lasting > 3 months, we do not know the pain duration total values in the groups, the prevalence of headache, cramps in the lower abdomen, and depression during the previous six months. We also do not know if the investigated instruments (WPI + SSS) are sufficient to assess fibromyalgia symptoms or whether they should be associated with computerized tests. Besides, medication use was not controlled in that study, and we did not use a polysymptomatic distress scale— we suggest novel studies to investigate these limitations.Fibromyalgia patients (2016 ACR criteria) compared to other chronic musculoskeletal pain patients have higher levels of pain (at rest or after movement) and fatigue, greater impairment in functionality and global impact, and worse symptoms. Therefore, WPI and SSS instruments should be used exclusively to assess fibromyalgia symptoms.Below is the link to the electronic supplementary material.Supplementary Material 1


Background: Piriformis muscle syndrome (PMS) is characterized by symptoms of buttock pain and numbness radiating to the back of the thigh due to irritation of the sciatic nerve. This study aimed to evaluate the efficacy of dry needling (DN) therapy and exercise programs on pain, neuropathic pain, physical function, and disability in patients with PMS.Methods: Forty-four patients with PMS were included in the study. Patients were divided into two groups, those who were treated with DN three times once per week under ultrasound guidance and those who had an exercise program for three weeks. To identify the outcomes of the treatment modalities, pre-treatment and post-treatment first-month and third-month visual analog scale (VAS), Oswestry Disability Index (ODI) questionnaire, Lower Extremity Functional Scale (LEFS), and Douleur Neuropathique 4 (DN4) questionnaire scores were used.Results: There was no statistically significant difference between the groups in baseline scores of VAS (p = 0.548), DN4 (p = 0.446), and LEFS (p = 0.880), but in the DN group, baseline ODI scores were significantly higher than in the exercise group (p = 0.001). The group comparisons showed no statistically significant differences in decreasing pain, reducing disability, and increasing functional status scores among the groups at post-treatment first-month and third-month assessments (p > 0.05).Conclusion: Both treatment modalities are beneficial in reducing pain and disability, and increasing the functional status of the patients with PMS in three months of follow-up. In patients who cannot adapt to exercise programs, DN treatment under ultrasound guidance should be kept in mind as a minimally invasive treatment modality with no adverse effects. Piriformis muscle syndrome (PMS) is a neuromuscular disorder that can cause symptoms of hip joint motion limitation, buttock pain and tenderness, and numbness radiating to the back of the thigh due to compression or irritation of the sciatic nerve ,2. In thPiriformis muscle stretching is an exercise technique in physiotherapy that is generally used for patients with PMS. Exercises focused on relaxing the piriformis muscle aim to increase the resting length of the muscle and reduce the potential sciatic nerve compression because of this tightness . Local aThis study aimed to compare the effectiveness of DN treatment performed on the piriformis muscle once per week for a total of three times under US guidance and a three-week exercise treatment program in PMS. The secondary outcomes of this study were to evaluate and compare the effect of these treatment modalities on visual analog scale (VAS) scores, the Oswestry Disability Index (ODI), Lower Extremity Functional Scale (LEFS), and Douleur Neuropathique 4 (DN4) questionnaire scores in patients with PMS at three months follow-up.In this prospective observational study, between January 2022 and May 2023, 175 patients with unilateral hip pain who presented to the pain and physical medicine and rehabilitation outpatient clinic were evaluated. Forty-four patients aged 18-70 years, who were clinically diagnosed as having PMS after excluding other hip, lumbar, sacroiliac region, and lower extremity pain etiology diagnoses were enrolled in the study. The diagnosis was based on the patient’s history and physical examination, bearing positive flexion, adduction, and internal rotation (FAIR) test, and/or tenderness or trigger point at the piriformis muscle area and/or revealing pain with maneuvers such as Freiberg’s maneuver , Beatty’s maneuver , and Pace’s maneuver (resisted abduction of both thighs in the seated position). The demographic data  scores) and the side of the pain were noted. Each patient in the study received and signed an informed consent form.Despite all patients receiving oral medical treatment, their pain continued. The patients were divided into two groups, those who did accept DN treatment  and those who received physical exercise treatment . All patients in group 1 had DN treatment performed on the piriformis muscle once per week, a total of three times under US guidance. All patients in group 2 underwent an exercise program for three weeks.Overall pain severity was measured using a 0 to 100 -mm scale VAS. Pain disability was assessed using the ODI questionnaire, and physical function was rated using LEFS. The presence and severity of neuropathic pain were evaluated according to the DN4. To identify the outcomes of the treatment modalities, pre-treatment and post-treatment first-month and third-month scores were used. LEFS consists of 20 items that rate the ability of functional status in performing different physical activities due to musculoskeletal problems affecting the lower extremities. Each question has a five-point scale, scored from 0 to 4 . The total score ranges from 0 to 80, with higher scores indicating better functional status .The Turkish validity and reliability study of LEFS was performed by Citaker et al. . The DN4Exercise protocolA home-based static self-stretching technique was described and patients were given an additional exercise plan of bilateral bridging, side leg raises with hip and knee flexion to 45 degrees and feet together by the therapist, and they were taught to refrain from sacral sitting, change their posture every 30 minutes, and lift heavy objects sparingly. The stretching position was sustained for 30 seconds, with 10 repetitions/sets enforced twice daily. A form containing exercise images was given to facilitate patient recall.DN intervention protocolAfter a signed informed consent form was obtained from each patient who underwent DN in the study, a total of three sessions of DN treatment were performed once per week by the same experienced pain physician (researcher) to the piriformis muscle under US guidance on all patients in the DN group. DN was performed in an intervention room under sterile conditions with the patient in the prone position. A pillow was placed under the abdomen to exclude lumbar lordosis. A low-frequency (2-5 MHz) transducer was placed in the gluteal region in a slightly oblique position and sonographic scanning was started. First, the large mountain shadow of the iliac crest and gluteus maximus muscle was sonographically visualized in the midline. Then, the transducer was shifted inferiorly until the sciatic notch was visualized. When the sciatic notch, sciatic nerve, and pear-shaped piriformis muscle above it were visualized, the patient's knee was flexed and the leg was rotated internally and externally, and the typical sliding motion of the piriformis muscle was observed. After the target point was determined, a 22-G spinal needle was inserted from lateral to medial or from medial to lateral using the in-plane technique Figure  20]. Th. Th20]. DeclarationsEthical approval for the study was obtained from the Ethics Committee of the University of Health Sciences Turkey, İzmir Tepecik Education and Research Hospital . The study was conducted in accordance with the Declaration of Helsinki. The patients were informed about the study and each provided oral and written informed consent.Statistical methodsNormally distributed continuous data are presented as mean and standard deviation and non-normally distributed data are presented as median and interquartile range. Categorical variables were analyzed using frequency tables, and descriptive statistics were calculated for continuous variables. Independent sample t-tests and Mann-Whitney U tests were conducted to compare parametric and nonparametric continuous data, respectively. Pearson’s chi-square test was used to analyze categorical data in terms of groups. Non-parametric repeated measures comparisons for each group were analyzed using the Friedman test. In all hypothesis tests, p < 0.05 was considered significant. Odds ratios at 95% confidence intervals (CI) for each parameter were calculated for each variable. The statistical analysis was conducted using the IBM SPSS version 25.0 statistics package .Forty-four patients with PMS who met the inclusion criteria were included in the study. The mean age of the patients in the DN group was 44.6 ± 10 years, and in the exercise group, it was 41.4 ± 9.2 years. There was no statistically significant difference (p > 0.05) in age distribution between the groups. The DN group consisted of 14 female and eight male patients, and the exercise group comprised 20 female and two male patients. Females were significantly more in the exercise group (p < 0.05) in comparison to males. The mean BMI scores were 26.1 ± 2.1 kg/m2 and 25.1 ± 4.6 kg/m2 in the DN and exercise groups, respectively (p > 0.05). No significant differences (p = 0.364) were noted in BMI distribution between the study groups. The demographic characteristics of the groups are summarized in Table Although there was no significant difference between the groups in baseline scores of VAS, DN4, and LEFS (p > 0.05), the DN group's baseline ODI scores were significantly higher than those in the exercise group (p < 0.05). The within-group comparison had shown statistically significant differences from baseline scores with the post-treatment first-month and third-month scores in each group, in terms of pain, neuropathic pain, disability, and functional assessment values. The between-group comparison showed no significant difference in decreasing pain, reducing disability, and increasing functional status scores among the groups at post-treatment first-month and third-month assessments Table .In the present study, both a three-week exercise program and a total of three sessions of US-guided DN treatment once per week were found to be effective in pain intensity, neuropathic pain, and quality of life parameters in a three-month follow-up of patients with PMS. The ODI scores of the DN group were significantly higher at admission, which may suggest that patients with low quality of life due to pain are more often referred to outpatient pain clinics. In the literature, DN treatment of the piriformis muscle under US guidance is often in the form of case reports and there is no study comparing exercise programs and DN therapy efficacy. Our study will contribute to the literature because it evaluates both pain severity and the effect on lower extremity function, neuropathic pain, and quality of daily life.PMS is a painful condition frequently associated with sciatic nerve symptoms caused by compression of the sciatic nerve due to anatomic variations in the piriformis muscle or secondary reasons ,21. MediIn a study conducted by Tabatabaiee et al., 32 patients with PMS were randomly divided into two groups, patients who underwent three sessions of US-guided DN to the piriformis muscle and a control group. The primary outcome of the study was pain intensity (VAS) recorded at baseline and then 72 hours and one week after treatment. At the one-week follow-up, patients with PMS in the DN group showed clinically significant short-term improvement in pain intensity . SimilarIn a case series study, US-guided DN treatment was performed on the piriformis muscle and gluteus minimus, medius, and maximus muscles on three patients with the same symptom duration. All patients were administered eight to 12 sessions of DN for 10 days and were followed up for six months. Their symptoms and quality of life improved during this period and no adverse effects were reported . In our Stretching reduces muscle pain, prevents injury, and increases flexibility, thus it improves physical performance and ability . Alarab Piriformis syndrome is most common between the ages of 30 and 49 years and affects individuals of all physical activity levels and occupations. In our study, occupation diversity and the ranges of patients' ages were consistence with the literature [Our study has certain strengths. The study's comprehensive assessment and management plan was clinically feasible, cost-effective, and patient-focused. After the treatment was completed, the patient's follow-up was three months. The limitations of the study can be listed as the relatively short follow-up period, the non-randomized study design, and the lack of a control group.Both treatment modalities were beneficial in reducing pain and disability and increasing the functional status of the patients with PMS in three months of follow-up. Stretching, on the other hand, is a simple, easy, and cheap conventional treatment approach that is accomplished without the requirement for supervision. In patients who cannot adapt to exercise programs, a single session of DN treatment to the piriformis muscle once per week under US guidance should be kept in mind as a minimally invasive treatment modality with no adverse effects.


Opioid consumption was reduced by 9%. More importantly, use of the NeuroCuple™ devices reduced the number of patients requesting an opioid prescription following discharge from the hospital by 52% . Conclusions: Our data suggest that the NeuroCuple™ device may be an effective non-pharmacological alternative to opioids to manage postoperative pain following unilateral arthroplasty due to its ability to reduce postoperative opioid use.Background: The potential effectiveness of the non-pharmacological and nanotechnology-based NeuroCuple™ device in reducing postoperative surgical pain and opioid consumption remains unknown. Methods: This randomized controlled open-label study was conducted in patients undergoing a primary unilateral total knee or total hip arthroplasty. In the recovery room, patients were randomized to receive either standard of care (control group) or standard of care plus two NeuroCuple™ devices. The outcome variables included pain and opioid consumption . Results: A total of 69 patients were randomized to either the NeuroCuple™ group (n = 38) or the control group (n = 31). Use of the NeuroCuple™ devices was associated with a significant 34% reduction in pain at rest (means of area under the curve: 6.3 vs. 9.5;  In 2017, it was estimated that the United States spent over USD one trillion annually on opioid addiction . Major sIt is also well established that administration of opioids is associated with adverse effects such as post-operative nausea and vomiting, immunosuppression, constipation, and, in some cases, death by respiratory depression and/or hypotension ,9,10,11,Recently, the NeuroCuple™ device  was developed based on nanotechnology. The NeuroCuple™ device is comprised of three layers, including two outside thin layers of medical grade material that are flexible, durable, and latex-free and an internal layer containing millions of nanocapacitors . An obsehttp://www.ClinicalTrials.gov (NCT 05252858).This pilot study was conducted at a single center. It was a prospective, randomized, open-label clinical trial conducted at UPMC  Shadyside Hospital, Pittsburgh, PA, US. Before any eligible patients were recruited and consented, institutional review board approval was obtained (STUDY22010018) and the trial was registered at Inclusion Criteria: (1) 18 years of age or older. (2) PROMIS® Emotional Anxiety Short Form 8a questionnaire completed with a T-score of ≤57.2. (3) Scheduled for elective primary unilateral TKA or THA. (4) Opioid naïve (use of less than 60 mg OME daily for the last 30 days). (5) Signed written informed consent. Exclusion Criteria: (1) Pregnancy. (2) Deemed not suitable for the study at the discretion of the principal investigator. (3) Chronic use of opioids (use of more than 60 mg OME daily for the last 30 days). (4) Active depression, anxiety, or catastrophizing. (5) Active alcoholism or drug abuse. (6) Severe chronic pain condition requiring daily preoperative opioids. (7) Breastfeeding. (8) Concurrent participation in any other clinical trial.Patients undergoing TKA or THA were screened and recruited based on the following criteria. ® Emotional Anxiety Short Form 8a questionnaire [® Emotional Anxiety Short Form 8a questionnaire were fully eligible for the study enrollment. Before transferring to the operating room, each patient was also asked to complete the PROMIS® Emotional Depression Short Form 8a [Study recruitment comprised two phases. In phase I, after reviewing and signing an informed consent, each patient was asked to complete a PROMISionnaire  to elimiionnaire ,15,16. I Form 8a ,14,15,16 Form 8a ,18,19.®), distributed by the University of Pittsburgh Clinical and Transitional Science Institute, Pittsburgh, PA, USA), in hospital and after discharge.TKA or THA surgeries were performed under spinal anesthesia and propofol infusion for sedation. In the recovery room, participants were randomized to receive either the standard of care plus the NeuroCuple™ device (treatment group) or the standard of care alone (control group). The randomization of both groups occurred by assigning the participant a subject ID number, and this ID number corresponded to a treatment allocation based on a pre-established electronic simple randomization (1:1) schema. Because of the lack of a placebo NeuroCuple™ device (device without nanocapacitor), the standard of care served as control. Because of the relatively small size of the NeuroCuple™ device, two NeuroCuple™ devices were placed on each side of the thigh in participants randomized to the treatment group. Pain at rest and during movement were assessed by the Numerical Rating Scale . Total opioid consumption was expressed in oral morphine equivalents . The number of additional opioid prescriptions requested by the patients after the initial opioid prescription provided at discharge was reported. At the time of discharge from the hospital, each patient was provided with a three-day opioid prescription and instructed to contact the surgeon’s office if they needed another opioid prescription. The number of opioid prescriptions was recorded using the PDMP .® Anxiety, Depression, and Sleep Disturbance questionnaires and the pain catastrophizing scores recorded prior to surgery and on postoperative days (PODs) 1, 2, 3, 7, 14, and 30 were also recorded. Functional recovery was assessed by asking the patient the following three questions: Are you able to (a) walk 100 feet (No = 0 or Yes = 1)? (b) Move up five steps (No = 0 or Yes = 1)? (c) Raise your leg ? Total scores could vary from 0 to 4. Each patient was asked to complete a survey to rate their overall satisfaction at discharge and on POD 30 on a scale of 0 to 10 (0 = extremely dissatisfied and 10 = the most satisfied). On POD 30, each patient was asked to rate their overall pain treatment satisfaction on a scale of 0 to 10 .The time to discharge from the recovery room and the hospital was also collected. T-scores on the PROMISPower calculation prior to the enrollment indicated that a total of at least 60 patients (30 per group) was required. The total number of patients randomized was 69 to account for two patients who withdrew from the study and to allow randomization of a total of 60 patients who underwent TKA, because most enrolled patients underwent TKA rather than THA (60 TKA vs. 9 THA). Data were analyzed using intention-to-treat analysis. Data are summarized as mean ± standard deviation (SD) for continuous variables and numbers with percentages (%) for categorical variables. The area under the curve (AUC) for pain scores was calculated using the trapezoid rule from PODs 1 to 30, PODs 1 to 3, and PODs 7 to 30. The percent reduction was determined by calculating the difference in means or proportions (treatment group—control group), which was then divided by the mean or proportion in the control group for each outcome. The non-parametric Kruskal–Wallis test was used to determine the differences in the distribution of continuous outcomes, and Pearson’s chi-squared test was used for differences in the proportions for categorical outcomes between the NeuroCuple™ and control groups. The statistical software package SAS  was used for the analyses. All tests were two-sided and the alpha level was set at 0.05.® Emotional Anxiety Short Form-8a T scores were ≥57.2 (63.1 ± 4.73). Consequently, 69 patients were randomized . Among the patients randomized, nine underwent THA and 60 underwent TKA, including two patients who withdrew consent on POD 2 from the treatment group (one THA and one TKA)  and a 12% reduction in pain during movement . Opioid consumption was reduced by 6.6 mg in the NeuroCuple™ group . The percentage of patients who did not use opioids during the first three postoperative days was greater in the NeuroCuple™ group . Similar data were observed for pain and opioid consumption during PODs 7-30 and PODs 1-30 (As indicated in ODs 1-30 .p = 0.016). the percentage of patients in each group who called the surgeon’s office and asked for an opioid prescription refill within the first 30 days following surgery.More importantly, as presented in p = 0.62). Overall patient satisfaction at discharge and on POD 30, as well as satisfaction regarding pain surveyed on POD 30, were similar between the NeuroCuple™ and control groups (The length of hospital stay in the NeuroCuple™ group was reduced by 23% compared with the control group (l groups . No locaPatients undergoing TKA and THA often request opioid refills . Our datThe medical application of nanotechnology is recent and considered to have limitless indications because this technology allows the transport and delivery of nanoparticles, micelles, quantum dots, liposomes, nanofibers, and nanoscaffolds ,30,31,32® Anxiety questionnaire. This explained why we only included patients with T-scores ≤ 57.2. We decided to eliminate any central interferences [In this study, we focused on patients without significant anxiety prior to surgery who were identified by screening with the PROMISferences ,16, sincThe NeuroCuple™ device is an innovative application of nano and quantum technology because it focuses on a macro device containing a very large number of nanocapacitors. The proposed mechanism of action for the NeuroCuple™ device in pain is based on the concept that local trauma is associated with the destruction of biological capacitors. In physiologic conditions, cell membranes act as biological capacitors, leading to the distribution of electrons and electrical charges on each side of cell membranes and the role of the piezoelectric properties they display ,41,42. TThis study should be considered as a pilot study and suggests that nanotechnology may represent an alternative to opioids for the perioperative management of pain following joint arthroplasty. However, the following limitations need to be acknowledged. One, the study did not include a placebo NeuroCuple™ device arm. This was because a placebo NeuroCuple™ device was not available. Second, because the design of the NeuroCuple™ device used at the time of the study was too small to cover the femoral nerve territory, we were required to use two NeuroCuple™ devices for each patient. At our request, nCap Medical has developed a new device. This new NeuroCuple™ device is presented in Our study suggests that the NeuroCuple™ device may be a promising non-pharmacologic alternative to manage postoperative pain and reduce the need for opioid prescription refills following joint arthroplasty. This is especially interesting in the context of the current opioid crisis, because the persistent use of opioids following surgery puts patients at risk for OUD. However, additional studies based on a placebo-controlled design and using a longer NeuroCuple™ device are required to confirm the potential value of the NeuroCuple™ device as an alternative to opioid use in patients undergoing joint arthroplasty.


Previous studies have indicated that pain‐related diseases can result in significant functional alterations in the brain. However, differences in spontaneous brain activity in toothache (TA) patients remain unclear.To investigate altered spontaneous brain activity in patients with TA and its underlying mechanisms using the resting‐state functional magnetic resonance imaging–fractional amplitude of low‐frequency fluctuation (rsfMRI–fALFF) technique.Twelve patients with TA and 12 non‐toothache controls (NTCs)  were enrolled. Spontaneous cerebral activity variations were investigated using the rsfMRI–fALFF technique in all individuals. The mean fALFF values of the TA patients and NTCs were classified using receiver operating characteristic (ROC) curves. The correlations between fALFF signals of distinct brain regions and clinical manifestations of TA patients were evaluated using Pearson's correlation analysis.r = .962, p < .001).TA patients showed lower fALFF values in the left superior frontal gyrus, medial; right superior frontal gyrus, dorsolateral; and left median cingulate and paracingulate gyri (LDCG) than the NTCs. Moreover, ROC curve analysis indicated that the area under the curve of each cerebral region studied had high accuracy. Besides, in the TA group, the visual analog scale score was negatively correlated with fALFF signal values of the LDCG (Abnormal spontaneous activity was detected in numerous brain regions in patients with TA, which may be valuable for understanding the brain processing mechanism underlying TA. These regional changes in brain activity may serve as effective clinical indicators of TA.  In addition to tooth disease, periodontal tissue and jaw diseases and various nerve and systemic diseases can also lead to TA Raab, . The preThe formation of TA is a complex process that is related not only to craniofacial sensory neurophysiology but also to emotional, pain behavioral, cognitive, and psychological factors  is one of the most widely used tools for studying the neural substrates of the pain experience .22.1n = 4 males and n = 8 females) were recruited from the Affiliated Stomatological Hospital of Nanchang University and the First Affiliated Hospital of Nanchang University. Inclusion criteria of TA patients were as follows: (1) pain in the pulp or periodontal tissue of teeth of either dental or nondental origin; (2) acute and chronic TA; (3) no other pain diseases; (4) capable of undergoing MRI examination; (5) no abnormal signal changes observed during conventional MRI examination; (6) no history of drug and alcohol addiction; and (6) TA has no obvious cause and cannot be attributed to any other diseases. Exclusion criteria were as follows: (1) headache, temporomandibular disorders, fibromyalgia, back pain, or other non‐TA conditions; (2) first‐generation family history of pain, such as headaches; (3) other neurological or psychiatric disorder; and (4) contraindications to MRI.In this study, a total of 12 TA patients  no symptoms of TA; (2) no under obvious pain conditions; (3) no abnormalities of cerebral parenchyma on the MRI examination; (4) no cardiovascular disease, mental illness, or cerebral infarction; (5) no history of drug and alcohol addiction; (6) no contraindications for MRI examination, such as implanted metal devices or a cardiac pacemaker; and (7) can tolerate MRI examination.This study complied with the Declaration of Helsinki and was formally approved by the Medical Ethics Committee of the Affiliated Stomatological Hospital and the First Affiliated Hospital of Nanchang University. The Medical Ethics Committee also approved the study. All volunteers provided written informed consent after they were informed of the study objectives, protocol, and inherent risks of the study.2.2The visual analog scale (VAS) was used to measure pain in TA patients. Using a 10‐cm ruler, patients ranked the degree of pain they were currently experiencing on a scale of 0–10. A higher score indicated more intense pain. Patients rated their pain on the VAS just before the scanning session. NTCs rated on the same time while their pain did not refer to a specific kind of pain.2.3All individuals underwent conventional MRI before BOLD cerebral function examination using rs‐fMRI, and no abnormal signal changes in cerebral structure were observed. The MRI scanning was performed using a 3T magnetic resonance scanner with an eight‐channel phased‐array head coil . The TA group underwent rs‐fMRI scanning under the condition of persistent TA. During the entire scanning process, all participants were instructed to remain awake while breathing regularly with their eyes closed. The rs‐fMRI data were acquired using a gradient echo‐echo planar imaging sequence. Relevant detailed parameters were as follows: 30 axial slices and 240 functional images . In addition, we obtained structural images for each individual using a T1‐weighted three‐dimensional magnetization‐prepared 180 degrees radiofrequency pulses and rapid gradient‐echo sequence . The entire scanning process lasted 15 min.2.4sc.edu]) to remove incomplete data. During magnetization equilibration, the first 15 time points were discarded. The Data Processing Assistant for Rs‐fMRI Advanced Edition  software was used for head motion correction, spatial normalization, slice timing, digital imaging communications in medicine form transformation, and full‐width smoothing with a Gaussian kernel of 6 × 6 × 6 mm3 at half‐maximum, based on the rs‐fMRI data analysis toolkit  and Statistical Parametric Mapping software . We would have excluded subjects if they have had excessive angular motion or >1.5 mm maximum shift in the x, y, or z direction during the fMRI examination. No participants were excluded due to head motion.No filtering was used in the preprocessing. We first applied the MRIcro software  were eliminated using linear regression. After correcting for head motion, the functional images were normalized to Montreal Neurological Institute space using a standard echo‐planar image template. The global effects of variability were reduced by dividing the fALFF value of each voxel by the global mean fALFF value of each subject. Hz range within which fALFF of each voxel was calculated.2.5p < .05 was considered statistically significant.The REST software was used to classify brain regions with differences in fALFF value between the two groups as ROIs. The mean fALFF value was calculated for each ROI by averaging across all voxels within the ROI. The relationship between behavioral performance and the mean fALFF value of each ROI was analyzed using linear correlation analysis in the TA group. A 2.6t‐tests and chi‐square tests. Differences with a p < .05 were considered statistically significant. A two‐sample t‐test was used to compare functional data using the REST software. The voxel‐level statistical threshold for multiple comparisons using Gaussian random field theory was set at p < .05. The voxel‐level AlphaSim was corrected at p < .01 with a cluster size of >40 voxels. Receiver operating characteristic (ROC) curves were used to categorize brain regions that significantly differed in mean fALFF values between TA subjects and NTCs. The correlations between the obtained fALFF values and clinical features of TA patients were investigated using Pearson's correlation analysis.The SPSS software version 26.0 was used to compare demographic and behavioral variables between the TA and NTC groups using independent sample 33.1p = .704). The educational level of all patients matched those of the NTCs. The duration of TA was 1.92 ± 0.76 years. Table Age did not significantly differ between the TA and NTC groups , right superior frontal gyrus, dorsolateral (RSFGdor), as well as the left median cingulate and paracingulate gyri (LDCG) Figure ; Table 23.3p < .0001; 95% confidence interval [CI]: .827−1.000); RSFGdor, .993 ; LDCG, 1.000   was .5−.7, whereas an AUC of .85−.95 denoted high accuracy. Individual AUC values for the fALFF value of different regions were as follows: LSFGmed, .937  is involved in motor activity . The ACC is involved in emotion and movement, whereas the PCC is mainly engaged in memory and some visual functions  and posterior midcingulate cortex and, to a lesser extent, the pregenual ACC (pgACC). Among these, the contralateral (left) aMCC and pgACC showed linear BOLD signal changes that correlated to physical stimulus strength. Generally, the aMCC divisions are associated with cognitive–evaluative functions, whereas the pgACC is linked to emotional and/or affective dimensions of stimulus perception as well as to skeletomotor orientation in response to pain , which indicated that, as the degree of TA increased, the BOLD signal intensity of this region declined. This may be related to the reduction in blood supply or neuronal activity in this region. It is known that the cingulate gyrus is involved in the formation of pain sensation and the encoding of pain emotional information (Zhuo, We found that the fALFF values of the LDCG were strongly negatively correlated with the VAS score (on Zhuo, ; thus, tThis study has several limitations. First, our sample size was small. Studies in larger sample sizes are needed to obtain more precise results. And classification with the ROC curve done on such a small sample size is a statistical limitation. Second, the inclusion criteria were not rigorous; acute and chronic TAs were not differentiated. Third, medication usage, which might affect brain activity, was not included in the exclusion criteria. In addition, we did not classify odontogenic and nonodontogenic pain in the inclusion criteria for patients with TA. It is also important to note that, even under the same conditions, the pain experience is not static over time within an individual; moreover, pain perception fluctuates over time (Bi et al., Taken together, we revealed that patients with TA have abnormal spontaneous neural activity in specific brain regions, which provided insight into the variation of central nervous system activity in TA patients and potential pathological mechanisms underlying TA pain. In addition, we revealed a strong correlation between the VAS score and fALFF value of the LDCG, which suggested that the degree of pain is closely related to the cingulate gyrus. At present, there are few studies on the reductions in BOLD signal intensity in the brain and the mechanisms underlying painful conditions. Our study provides new research avenues for investigating the relationship between various painful conditions and BOLD signal intensity in specific brain regions. Moreover, our findings offer support for the use of fALFF values as an indicator of pain degree. Since fALFF reflects changes in spontaneous brain activity and is entirely objective, it is conducive to our evaluation of pain intensity and the state of illness.5This study showed that patients with TA have abnormal spontaneous neural activity in specific brain regions and that fALFF values of the LDCG are strongly correlated with the VAS score. Our findings provide insight into the variation of central nervous system activity in TA patients and indicate potential pathological mechanisms underlying TA pain. We suggest that the cingulate gyrus plays a vital role in the production and formation of TA and that fALFF signals could be an effective marker of pain severity.The authors declare no conflicts of interest.https://publons.com/publon/10.1002/brb3.2937.The peer review history for this article is available at