Chronic pelvic pain, defined as persistent pain in the structures of the pelvis, is a condition that significantly impacts the health-related quality of life (HRQoL) of up to one-third of people worldwide, with substantial associated costs to both the individual and healthcare system/s. The present trial aims to establish the efficacy of e-hypnotherapy over relaxation and waitlist controls on pain, HRQoL and biopsychosocial outcomes, and evaluate cost-effectiveness.

A parallel-group, investigator-blinded, randomised controlled trial will be conducted. Eligible participants will be randomly allocated to either a 7-week online personalised e-hypnotherapy programme (n=44), a 7-week online personalised relaxation control (n=44) or waitlist control (n=44). The primary outcome will be self-reported pain level, and secondary outcomes will include psychological distress, QoL, pain catastrophising, self-efficacy, central sensitisation, somatic symptoms, fatigue and sleep. Cost-effectiveness will also be examined. Longitudinal qualitative interviews will be conducted with participants in the e-hypnotherapy (n=20) and relaxation (n=20) groups to understand meaningful change and barriers/facilitators for ongoing use.

This protocol has received ethics approval in Australia from the Deakin University Research Ethics Committee (DUREC ref. 2024-080). Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences related to chronic pelvic pain and mind–body interventions.

Australian New Zealand Clinical Trials Registry ACTRN12623000368639p.

Postoperative gastrointestinal dysfunction (PGD) is a common complication in patients with oesophageal cancer (OC). This complication is also a crucial factor affecting the prognosis of patients and increasing their medical burden. Gastrointestinal decompression and gastrointestinal motility-promoting oral drugs can partially relieve the symptoms, but some limitations of these treatment methods remain. Alternative therapies offer a new option for postoperative patients. This experiment will evaluate the safety and efficacy of electroacupuncture for PGD in patients with OC.

From January 2024 to December 2025, 156 patients with perioperative EC will be recruited from three Grade-A tertiary hospitals in China. The participants will be randomly assigned to one of the three groups: electroacupuncture plus standard treatment group, sham electroacupuncture plus standard treatment group and standard treatment group at a 1:1:1 ratio (with the treatment conducted four sessions). The follow-up period is 30 days. The primary outcome indicator is the time of first defecation. The secondary outcome indicators are the time of first exhaust, quality of life after surgery, length of hospital stay after surgery, tolerance time for semiliquid and solid foods, time of first ambulation, I-FEED scores, demand for postoperative analgesics and defecation drugs, European Quality of Life-5 Dimensions-5 Levels scores, Hospital Anxiety and Depression Scale scores and changes in laboratory examination indicators. All adverse reactions will be recorded.

This study has been approved by the ethics committee of the First Affiliated Hospital of Naval Medical University (No CHEC-2024–209). Written informed consent was obtained from all participants before the formal start of the clinical trial. The results of the clinical trial will be disseminated in peer-reviewed publications.

ITMCTR2024000118.

To evaluate the reporting quality of recent randomised controlled trials (RCTs) of acupuncture for low back pain (LBP) and investigate associated factors.

A systematic review was conducted to identify and evaluate the reporting quality of RCTs of acupuncture for LBP reported after 2020. The Consolidated Standards of Reporting Trials (CONSORT), STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) and CONSORT-Outcomes statements were used to evaluate the reporting quality of the included studies. Regression analyses were performed on pre-specified study characteristics to explore factors associated with the reporting quality.

Cochrane Library, PubMed, Web of Science, Embase, China National Knowledge Infrastructure (CNKI), Wan Fang, VIP Database and Chinese Biomedical Literature Database were systematically searched from January 2021 to January 2025.

Only RCTs enrolling patients with LBP diagnosed according to the criteria of the North American Spine Society or other recognised clinical guidelines were included. The eligible interventions comprised manual acupuncture, electroacupuncture and other acupuncture-related therapies. Publication language was restricted to English and Chinese.

Literature screening, data extraction and reporting quality assessment were independently conducted by two reviewers with professional training. Any discrepancies were resolved by a third reviewer.

Fifty-seven RCTs were ultimately included, with a median overall quality score of 32 (range, 17–54). The CONSORT-based median quality score (QS) was 14 (range, 7–31). Among the 37 items comprised in the statement, 11 were sufficiently reported (reporting rate, >80%), whereas 19 were inadequately reported (reporting rate,

RCTs of acupuncture for LBP should focus more on reporting open science, key methodology, details of acupuncture and comprehensive outcome-related information. Authors and journals, especially those in China, need to strengthen their adherence to the CONSORT statement and its extensions to enhance the reporting quality of RCTs.

Lumbar back myofasciitis (LBM) is a common condition caused by cold exposure, lumbar injuries or poor posture, leading to aseptic inflammation, fibrosis and chronic pain. While acupuncture stimulation of trigger points is widely used, clinical evidence supporting its efficacy remains limited. This study aims to evaluate the effectiveness and safety of acupuncture stimulation of trigger points in the treatment of LBM and to explore the underlying analgesic mechanisms.

This single-centre randomised controlled trial will be conducted at Acupuncture and Moxibustion Hospital of China Academy of Chinese Medical Sciences. A total of 60 participants will be randomly assigned to either the experimental group or the control group in a 1:1 ratio. The primary outcome measure will be the Visual Analogue Scale for pain, while secondary outcomes will include pressure pain threshold, ultrasound, infrared thermography and Roland-Morris Disability Questionnaire.

Ethics approval was obtained from the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences (Approval No. 2024XLW007-2). The findings of this study will be published in peer-reviewed journals. Prior to participation, all eligible participants will be given informed consent.

ITMCTR2025000258.

Post-COVID-19 syndrome, defined by persistent symptoms lasting beyond 12 weeks of a SARS-CoV-2 infection, affects both severe and mild COVID-19 cases. Fatigue is the most common symptom, impacting 58% of patients. Other symptoms include mental symptoms, cardiovascular and respiratory issues and autonomic dysfunction. Chronic inflammation and immune dysregulation seem to be associated with post-COVID-19 fatigue. Despite its impact on healthcare and the economy, effective treatments are limited. Yoga and health education have been shown to be effective for fatigue in other related conditions. The aim of this study, therefore, is to investigate the efficacy, safety and cost-effectiveness of yoga and health education on post-COVID-19 persistent fatigue.

A randomised controlled trial with 100 patients with persistent fatigue due to post-COVID-19 syndrome is being conducted at three study centres. Patients are randomised to two interventions, yoga and health education. Both interventions include 12 weeks of 90 min supervised group sessions and 60 min of home practice per week. The primary outcome measure is fatigue on the Chalder Fatigue Scale 12 weeks after randomisation. Secondary outcome measures include postexertional malaise (DePaul Symptom Questionnaire), health-related quality of life (Short Form Health Survey-12 Item Version, EuroQol 5-Dimension 5-Level Questionnaire), anxiety, depression (Hospital Anxiety and Depression Scale), stress (Perceived Stress Scale), sleep quality (Pittsburgh Sleep Quality Index), hand grip strength, laboratory parameters and adverse events. Physical activity analysis over 7 days using a body-worn sensor and 24-hour heart rate variability using a 3-channel ECG recorder are assessed exploratively. All outcome measures will be assessed 12 and 24 weeks after randomisation. In addition, health economic analyses as well as mediator and moderator analyses including self-reported body awareness, self-efficacy, personality traits and treatment credibility/expectations will be conducted. Furthermore, qualitative interviews at week 12 will be carried out.

The trial received ethical approval from the Ethics Committee of the University Hospital Tübingen (approval number: 775/2022BO2). Results will be disseminated via peer-reviewed open-access publications, scientific conferences and targeted communication to patient organisations, healthcare providers and the wider public.

NCT05890599.

Conventional treatments, like immunosuppressants for systemic lupus erythematosus (SLE), are associated with many side effects. Transcutaneous vagus nerve stimulation (tVNS) emerges as a promising adjunctive therapy, potentially offering a more benign therapeutic avenue for patients with SLE. The increased number of clinical trials, including randomised clinical trials, highlights the importance of a systematic review and meta-analysis to evaluate the efficacy and safety of tVNS in treating SLE. Consequently, the aim of this systematic review and meta-analysis protocol is to synthesise the available evidence to elucidate the efficacy and safety of tVNS for the treatment of SLE.

Databases include PubMed, Cochrane Library, Web of Science, Embase, Wanfang Database, China National Knowledge Infrastructure, VIP Database and Chinese BioMedical Literature Database. Data selection, extraction and quality assessment by two independent reviewers. Fatigue is the primary outcome, and secondary outcomes include pain, quality of life, negative emotions, adverse events and measures of SLE disease activity. We will use instruments appropriate for each study type to assess the risk of bias. The credibility of evidence will be evaluated using the grading of recommendation, assessment, development and evaluation system. For meta-analysis, we will use RevMan software to perform data synthesis (V.5.4.1). Besides, publication bias assessment, sensitivity, subgroup and meta-regression analyses will be conducted as appropriate.

All data used in our study will be extracted from published clinical trials and, therefore, no ethical approval is required. Study results will be disseminated through peer-reviewed journals and relevant academic conferences.

PROSPERO CRD42024525580.

Allergic rhinitis (AR) is a common chronic inflammatory condition that significantly impairs quality of life (QoL) through symptoms such as nasal congestion, rhinorrhoea, sneezing and itching. Conventional treatments often show limitations, prompting interest in complementary therapies like herbal medicine (HM). HM is widely used in East Asian countries and has demonstrated potential in modulating immune responses and reducing AR symptoms. In Korea, a government pilot project expanded in 2024 to include AR under limited insurance coverage for HM, highlighting the need for robust clinical evidence on its safety and effectiveness.

This study is a multicentre, prospective registry conducted in 21 Korean Medicine (KM) clinics across Republic of Korea. The registry systematically collects real-world data on HM treatments for AR, focusing on patient demographics, treatment patterns and clinical outcomes. Participants meeting predefined criteria will receive HM or other KM therapies as part of routine care. Data will be collected bi-weekly for the first 4 weeks, with additional follow-ups at 6 and 12 months. Primary outcomes include changes in Total Nasal Symptom Score, QoL scores and safety evaluations, analysed using descriptive and inferential statistical methods.

This study was approved by the Institutional Review Board of Kyung Hee University on 11 December 2024 (Approval No. KHSIRB-24–631). The study findings will be published in peer-reviewed journals and presented at academic conferences.

KCT0010172.

Neck pain is a common global health problem and a leading cause of disability, imposing significant personal and societal burdens. Musculoskeletal manipulations are recommended as the first-line treatment for neck pain in clinical practice guidelines, valued for their non-invasive and cost-effectiveness.

To determine the most effective musculoskeletal manipulation for neck pain by integrating both direct and indirect evidence through a network meta-analysis, enabling comparisons among interventions even in the absence of direct head-to-head evidence.

Systematic review and network meta-analysis.

Web of Science, the Cochrane Library, Embase, PubMed, Clinical Trials Registry, China National Knowledge Infrastructure, VIP Database and Wanfang Data were searched from January 2013 to May 2025.

Randomised controlled trials (RCTs) involving adults (aged ≥18 years) with neck pain receiving musculoskeletal manipulations.

Paired reviewers independently extracted data. The primary outcome was pain intensity, assessed using the visual analogue scale or numeric rating scale (with total scores of 10 or 100 points). Secondary outcomes included neck disability measured by the neck disability index (with total scores of 50 or 100 points), cervical range of motion (flexion and extension) measured in degrees using a universal goniometer and adverse events. All included studies were assessed for risk of bias using the RoB 2.0 tool and categorised as ‘low’, ‘some concerns’ or ‘high’. A frequentist random-effects network meta-analysis was conducted to calculate weighted mean differences with its 95% confidence intervals were calculated. Comparison-adjusted funnel plots were used to assess publication bias when 10 or more studies were included, and the Grading of Recommendations, Assessment, Development and Evaluations approach was applied for the quality of evidence.

A total of 101 RCTs involving 7633 participants were included. Overall, 62 (61.3%) had high risk of bias, 18 (17.8%) had some concerns and 21 (20.7%) had low risk of bias. Moderate to very low-certainty evidence showed significant reduction in neck pain intensity compared with no treatment: multimodal treatment (pooled weighted mean difference (WMD): –36.65, 95% CI –61.02 to –12.28), active control (pooled WMD: –36.62, 95% CI –62.67 to –10.57), manual therapy (pooled WMD: –35.85, 95% CI –59.86 to –11.83), soft tissue technique (pooled WMD: –28.72, 95% CI –51.65 to –4.79) and mobilisation (pooled WMD: –20.23, 95% CI –39.87 to –0.06), with multimodal treatment being the most effective intervention (surface under the cumulative ranking curve (SUCRA)=100%). No publication bias was detected for neck pain intensity. Moreover, multimodal treatment was the most effective for reducing neck disability (SUCRA=96.3%), whereas manipulation was the most effective for improving cervical range of flexion (SUCRA=81.3%) and extension (SUCRA=78.2%).

Multimodal treatment (the combined use of two or more musculoskeletal manipulations) is the most effective intervention for reducing both neck pain intensity and neck disability. Manipulation is the most effective for improving cervical range of motion.

Sleep, a fundamental element of health, accounts for about one-third of our lives, and is as crucial as nutrition and exercise. Among university students, medical students are one subset that seems particularly susceptible to sleep problems, perhaps due to the length and complexity of their studies and being under a high level of stress. Yoga Nidra has been studied as a therapeutic intervention for various medical conditions. The aim of the study is to evaluate the efficacy of short-duration Yoga Nidra for improving sleep quality in students at a tertiary healthcare centre in Rishikesh, Uttarakhand.

A two-group parallel randomised controlled trial will be conducted among undergraduate medical students with a Pittsburgh Sleep Quality Index (PSQI) score >5. Efficacy of short-duration Yoga Nidra in comparison to sleep education will be evaluated for PSQI scores, heart rate variability, respiratory rate, pulse rate, body mass index, blood pressure, random blood sugar, lipid profile, interleukin 6, salivary cortisol, generalised anxiety disorder and depressive disorder. The intervention will be pre-recorded with the duration of 12 min. The intervention group participants will receive three sessions per week for 4 weeks. The sample size is 160 students. All analyses will follow the intention-to-treat approach using SPSS V.26. Descriptive statistics, test of associations, parametric and/or non-parametric methods (as appropriate) will be used to assess within and between group changes.

The Institutional Ethics Committee (All India Institute of Medical Sciences (AIIMS), Rishikesh) has approved the study (#AIIMS/ie,C/22/231) and the trial has been prospectively registered in Clinical Trials Registry-India: CTRI/2022/07/044426. The results will be published in a peer-reviewed journal.

CTRI/2022/07/044426.

To explore possible factors related to the increased likelihood of retirement from practice and increased number of complaints and concerns received by osteopaths in practice 10 years or more.

Online cross-sectional survey.

UK osteopathic healthcare.

UK-based osteopaths registered with the General Osteopathic Council.

570 questionnaires were eligible for analysis. Respondents were mostly women (57.5%), working in England (90.7%), white or white British (91.8%), 50–59 years of age (29.6%) and practicing for 0–5 years (16.9%). Osteopaths who had been in practice for 10 years or more were significantly (² tests, p

Osteopaths who have been in practice for 10 years or more have some significantly different demographics and aspects of clinical practice and patient management to those in practice less than 10 years. However, it is not clear whether these differences are influential in decisions for leaving practice or the increased number of concerns and issues received.

Considering the proven anti-inflammatory effects of curcumin, we aimed to investigate the effect of curcumin supplementation on fatigue and musculoskeletal health (primary outcomes) and depression and its side effects (secondary outcomes) in postmenopausal women.

This was a parallel-group, double-blind, randomised placebo-controlled superiority trial.

The trial was conducted at two general clinics in Tabriz, Iran, in 2023.

A total of 74 postmenopausal women were enrolled. The participants were women aged between 40 years and 60 years with normal menopause and at least 1 year after amenorrhoea.

They were randomly assigned (1:1 allocation ratio) using a block randomisation method to receive either 500 mg curcumin capsules (intervention group, n=37) or identical placebo capsules (control group, n=37) twice daily for 8 weeks. Both participants and researchers were blinded to the group assignments.

Data were collected using the questionnaires of demographic characteristics, short form of the perimenopausal fatigue scale, musculoskeletal health, Beck Depression Inventory (BDI-13) and the side effects checklist. Independent t, ANCOVA and Mann-Whitney U tests were used to compare the results between the two groups.

A total of 74 women were randomised, with 33 in the curcumin group and 31 in the placebo group completing the study and being included in the final analysis. After the 8-week intervention, ANCOVA adjusting for baseline values revealed that the curcumin group showed a statistically significant improvement in musculoskeletal health (mean difference (MD): 5.3; 95% CI: 3.3 to 7.4; p

In this trial, an 8-week supplementation with curcumin was more effective than placebo at improving musculoskeletal health and reducing fatigue score in postmenopausal women. The study was not able to demonstrate a significant effect on depression.

Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N72. Last updated version: 18 October 2022. Actual start of recruitment: 23 January 2023.

Acute pain in the postoperative period of cardiac surgery is mostly treated with opioid analgesics. However, with the risk of adverse reactions and complications, strategies which do not involve opioid analgesics can be considered, such as aromatherapy. This systematic review aims to analyse the effectiveness of aromatherapy in relieving pain in post-cardiac surgery patients.

Two researchers will independently and simultaneously conduct searches and select studies from the following databases: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Latin American and Caribbean Literature on Health Sciences, Scopus, Web of Science, Cochrane (Library) and clinical trial registries (clinicaltrials.com), with no language or publication date restrictions. Randomised and quasi-randomised clinical trials on the use of aromatherapy for pain relief in postcardiac surgery patients will be included. Then, two researchers will independently examine the studies based on inclusion criteria, extract data from the included studies and assess the risk of bias using the Risk of Bias 2 tool and the Risk of Bias in Non-randomized Studies of Interventions tool from Cochrane. Data will be synthesised using Review Manager software. The strength of the evidence will be evaluated using the Grading of Recommendation Assessment, Development and Evaluation approach. The literature search, study selection, review and meta-analysis stages will be conducted from early October 2025 to April 2026.

This study is based on secondary data, and therefore ethical approval from a research ethics committee was not required. The results will be disseminated through publication in a peer-reviewed scientific journal.

CRD42024568532.

Migraine, a major headache disorder of high prevalence, affects approximately one billion individuals globally and imposes a substantial socioeconomic burden. Acupuncture, as a modality of complementary and alternative medicine, is increasingly used by patients for migraine management. Nevertheless, the effectiveness of acupuncture in randomised controlled trials (RCTs) for this condition remains a subject of debate. The varying non-specific effects of different sham acupuncture (SA) techniques complicate the accurate assessment of true therapeutic effectiveness of acupuncture. This protocol details a systematic review and network meta-analysis (NMA) aimed at comprehensively evaluating both the effectiveness of acupuncture compared with various sham controls and the differential non-specific effects of different SA methods in migraine. Our aims involve: (1) evaluating the effectiveness of acupuncture relative to SA controls in migraine treatment; (2) comparing the effect sizes across different SA methods and (3) identifying potential factors that influence the outcomes associated with various sham interventions.

We will undertake a thorough investigation using multiple databases, including Wanfang Data, Cochrane Library, Web of Science, Embase, ClinicalTrials.gov, PubMed, Chongqing VIP Database, SinoMed, Cochrane Central Register of Controlled Trials, Chinese Clinical Trial Register, International Traditional Medicine Clinical Trial Registry and China National Knowledge Infrastructure, spanning from their initial records up to 12 November 2024. The inclusion criteria are RCTs that compare acupuncture with SA controls for migraine treatment. Studies with waiting-list or no-treatment controls will be included only if they also contain an SA arm. Studies focusing exclusively on chronic migraine patients (≥15 headache days per month) will be excluded. Two independent reviewers will perform study selection, data extraction using a standardised prepiloted form and risk of bias assessment. The primary outcome will be the standardised mean difference (SMD) in migraine frequency measures, allowing for the inclusion of various frequency metrics (eg, migraine attacks, migraine days, headache days). Secondary outcomes will include response rate (≥50% reduction in frequency), days with acute medication use, the number of migraine days per month, pain intensity (measured using tools such as the Visual Analogue Scale or Numeric Rating Scale), and scores from migraine-specific questionnaires, among others. The Cochrane Risk of Bias tool 2 (RoB 2) will be employed for bias assessment, along with the Confidence in Network Meta-Analysis online tool and the Grading of Recommendations Assessment, Development and Evaluation system. A frequentist NMA will be executed using Stata (V.18.0). The network structure will comprise: acupuncture as a single node (or multiple nodes if heterogeneity warrants), different SA methods as separate nodes, and waiting-list/no-treatment as a single node. In terms of continuous outcomes, the synthesis will be conducted using the SMD with a 95% CI for estimating effects. Heterogeneity, network inconsistency and potential publication bias will be scrutinised. As needed, meta-regression, subgroup analyses and sensitivity analyses will be executed.

Since this research is based on data from published sources, it does not necessitate formal ethical clearance. The results will be shared via articles in scholarly journals and during presentations at academic symposiums.

CRD42024620550.

To examine trends in Chuna manual therapy utilisation for musculoskeletal disorders (MSDs) following its inclusion in the National Health Insurance (NHI) system in Korea in 2019 using claims data from the Health Insurance Review & Assessment Service (HIRA).

Retrospective analysis of NHI claims data.

Nationwide medical institutions, based on HIRA claims data from April 2019 to December 2021.

All patients who received at least one Chuna therapy session during the study period.

Primary outcome: Annual trends in Chuna manual therapy claims. Secondary outcome: Patient demographics, therapy frequency, MSD diagnoses and concurrent therapies.

A total of 12 729 625 Chuna therapy claims were analysed, showing a gradual annual increase in utilisation from 2019 to 2021. The most common age group was 45–54 years (22.3%), with female patients comprising a higher proportion (55.8%) than male patients.

Low back pain (M54.5), lumbar sprain and strain (S33.5) and cervicalgia (M54.2) were the most common diagnoses. Patients receiving Complex Chuna (50% co-payment) had more treatment sessions than those receiving Simple Chuna or Complex Chuna (80% co-payment), with spinal disorders such as spinal stenosis (M48.0) and intervertebral disc disorders (M51.1, M50.1) associated with higher treatment frequency. Acupuncture was the most common concurrent therapy (97.4%).

This study is the first to comprehensively analyse Chuna therapy utilisation using nationwide NHI claims data. The findings confirm that Chuna therapy is widely used for MSDs, particularly among middle-aged and elderly patients with spinal or muscle-related conditions. Patients with severe or chronic spinal diseases were more likely to receive frequent Chuna therapy sessions. These results provide insights into the utilisation patterns of Chuna therapy and highlight the need for further research to refine reimbursement policies based on disease severity and patient characteristics.

Extensive progress has been made in improving pregnancy outcomes for in vitro fertilisation and embryo transfer (IVF-ET) patients through the use of electroacupuncture (EA) and transcutaneous electrical acupoint stimulation (TEAS). However, a clear and suitable recommendation for the parameter selection scheme of EA/TEAS remains elusive.

To evaluate evidence-based conclusions of different EA/TEAS parameters on improvement of pregnancy outcomes in patients undergoing IVF-ET and evaluate other factors that may affect pregnancy outcomes.

This meta-analysis systematically searched eight databases from inception to 27 August 2024, focusing on randomised controlled trials (RCTs) that evaluated the effectiveness of EA/TEAS in improving IVF-ET outcomes, with the primary outcome defined as clinical pregnancy rate (CPR), and secondary outcomes including biochemical pregnancy rate (BPR) and live birth rate (LBR). We further explored CPR variations associated with EA/TEAS parameters: waveform (dilatational vs continuous wave), frequency (low vs high) and treatment duration (20, 25, 30, 40, 60 min). Additionally, seven subgroup variables were analysed to identify potential influencing factors: routine treatment, intervention dose, intervention modality, mean participant age, control type, randomisation risk and allocation concealment risk.

A total of 27 RCTs (3786 participants) were included, with the quality of evidence ranging from moderate to very low. Compared with control groups, the use of dilatational waves significantly increased CPR (RR=1.36, 95% CI [1.17 to 1.58], p2=0). Similarly, low-frequency currents demonstrated a significant positive association with CPR (RR=1.38, 95% CI [1.25 to 1.51], p2=0) and a treatment duration of 30 min per session was associated with elevated CPR (RR=1.30, 95% CI [1.19 to 1.42], p2=0). Subgroup analyses revealed that the effect of EA/TEAS on CPRs varied significantly depending on therapeutic dose (p=0.029), with stronger associations observed in studies involving patients receiving high therapeutic dose compared with those receiving low therapeutic dose.

Current evidence suggests that dilatational waves, low-frequency currents and 30-minute treatment duration may improve CPRs, though findings require validation in larger trials. While parameter optimisation shows promise, stronger evidence is needed before standardising protocols. Future research should focus on rigorous RCTs to determine optimal parameters and dose-response relationships.

Chemotherapy-induced peripheral neuropathy (CIPN) is the most prevalent non-haematological, dose-limiting adverse event associated with platinum derivatives and taxanes. Currently, no effective prophylactic interventions for CIPN have been established. However, several studies have shown that acupuncture may alleviate symptoms of peripheral neuropathy, proposing it as a potentially effective strategy for CIPN prevention. This pilot trial will help determine the feasibility and efficacy of acupuncture for preventing CIPN. The results will provide valuable insights for designing a larger clinical trial and conducting power calculations.

This is a randomised sham-controlled trial. A cohort of 60 patients scheduled to receive chemotherapy will be enrolled and randomly assigned to either the electroacupuncture group or the sham acupuncture group. Eligible patients will receive nine treatment sessions administered over the course of three chemotherapy cycles. The primary outcome is the change in CIPN-related quality of life (QOL) measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) CIPN20 from baseline to the end of cycle three. Secondary outcomes include: neurotoxicity symptoms assessed by the Numeric Rating Scale, incidence of CIPN, chemotherapy status, insomnia symptoms measured by the Insomnia Severity Index, depression symptoms evaluated using the Beck Depression Inventory-II, anxiety symptoms assessed with the Generalised Anxiety Disorder-7 and fatigue symptoms measured by the Brief Fatigue Inventory. Adverse events will be meticulously recorded.

The study protocol (V.1.0, 29 July 2024) has been approved by the First Affiliated Hospital of Zhengzhou University (2024-KY-0853–001). All patients will provide oral informed consent and written informed consent before participating in this study. Trial results will be disseminated in peer-reviewed publications.

ITMCTR2024000390 (International Traditional Medicine Clinical Trial Registry, http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=16387992-8971-4218-9cd0-b623af91f9f3), registered on 3 September 2024.

Chronic low back pain (CLBP) and depressive symptoms (DS) are highly prevalent, burdensome, costly and comorbid health conditions. Osteopathic manipulative treatment (OMT) was shown to improve pain and disability in patients with CLBP; however, the effect on comorbid DS remains less certain. Interestingly, CLBP and DS seem to be associated with changes in interoception, which may be reversed by OMT.

The study protocol proposes a single-blinded, parallel-group, randomised controlled trial to investigate the effect of OMT on clinical symptoms (depression, pain and disability) and interoceptive functions (interoceptive accuracy, sensibility and awareness) in patients with CLBP and comorbid DS. A sample of 60 adult subjects with CLBP and comorbid DS shall be recruited from osteopathic, orthopaedic and physiotherapeutic practices and educational institutes for osteopathy, sports science, psychology and medicine in Hamburg, Germany. Participants will be randomly allocated (1:1 ratio) to receive six 45 min treatment sessions of either OMT (standard-OMT group) or sham treatment imitating OMT (sham-OMT group). Primarily, symptoms of depression, pain and disability will be assessed with the Beck’s Depression Inventory, Second Edition (BDI-II), Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI). Secondarily, interoceptive accuracy, sensibility and awareness will be evaluated using the Heartbeat Tracking Task (HTT), Multidimensional Assessment of Interoceptive Awareness (MAIA-2) and confidence-accuracy correspondence (CAC). Ancillary, the therapeutic alliance will be investigated with the Helping Alliance Questionnaire. Data will be collected at baseline (t₀), the first, third and sixth treatment sessions (t₁, t₃, t₆) and at 3 months follow-up (t₇). The findings will be analysed for between-group differences using descriptive (mean and SD) and inductive statistics (mixed analysis of variance). It is hypothesised that standard-OMT, compared with sham-OMT, will reduce depression, pain and disability (BDI-II, NRS, ODI) and increase interoceptive accuracy, sensibility and awareness (HTT, MAIA-2, CAC) in patients with CLBP and comorbid DS.

The study was approved by the ethics committee of the Medical School Hamburg (MSH-2023/288). The anonymised dataset will be published in an online repository, and the results will be published in peer-reviewed scientific journals.

DRKS00031694.

Temporomandibular disorders (TMDs) are a group of conditions affecting the temporomandibular joint (TMJ), masticatory muscles and associated structures, often leading to pain, dysfunction and a significant impact on quality of life. Epidemiological studies have estimated that up to 75% of the population in the USA exhibits at least one sign of TMD. Although conservative treatments, such as acupuncture and occlusal splints, have been recommended, evidence for their effectiveness remains inconclusive, and the combined effects of these interventions are not well understood.

This study aims to evaluate the efficacy of an intraoral balance appliance (IBA) combined with standard Korean medicine care, compared to Korean medicine care alone, in patients with chronic, painful TMD with myalgia.

A single-centre, two-arm, parallel, practitioner-blinded and evaluator-blinded, randomised controlled trial with a 1:1 allocation ratio will be designed to test the interventions. 76 patients with TMD with myalgia will be recruited and randomised. The interventions will include manual acupuncture and physical therapy for both groups, with the addition of IBA in the treatment group for 3 weeks. The primary outcomes of the study will be the Numeric Rating Scale (NRS) for pain and discomfort at the final visit at week 4. Secondary outcomes will include overall functional assessment of the TMJ using several scales, as well as evaluations of quality of life, patient satisfaction and AEs.

The recruitment started on 18 July 2024, and 37 patients were included as of 8 July 2025.

Ethical approval is obtained from the Kyung Hee University Korean Medicine Hospital Institutional Review Board (IRB number: KOMCIRB 2023-06-001). The result from this study will be actively disseminated through manuscript publications and conference presentations.

The protocol was registered with the Clinical Research Information Service (CRiS), Republic of Korea, on 30 October 2023, CRiS number KCT0008906 prior to the initiation of the study, and was revised on 7 July 2025 (https://cris.nih.go.kr/cris/search/detailSearch.do?seq=30270&search_page=M&search_lang=&class_yn=).

This study aimed to develop a core outcome set (COS) for trials evaluating the effects of complementary therapies in people with multiple sclerosis (pwMS). We sought to identify the outcomes most relevant to pwMS, their relatives and friends, healthcare professionals and researchers and to propose these for inclusion in future trials.

A participatory international research project using a mixed-method approach with qualitative and quantitative methods. The study included a scoping review and a national survey in Switzerland to identify candidate outcomes, followed by an international COS survey to rate the importance of these outcomes. The final phases involved two consensus meetings to refine and finalise the COS.

Data were sourced from the published literature and input from international stakeholders.

pwMS and other relevant stakeholders, including their relatives and friends, healthcare professionals and researchers.

A total of 770 individuals participated in the international COS survey of 39 candidate outcomes (662 pwMS, 27 relatives/friends, 58 healthcare professionals and 23 researchers). According to the survey results, 13 outcomes were added to the COS, 5 were excluded and 21 were classified as ‘no consensus’. 13 individuals (six pwMS, one pwMS’s friend, three healthcare professionals and three researchers) attended the first consensus meeting. Following the voting on the outcomes without consensus, seven outcomes were added to the COS, four were excluded and 10 outcomes were still classified as ‘no consensus’. The six members of the stakeholders advisory board (one pwMS, four healthcare professionals and two researchers) attended the second consensus meeting to define the final COS. Nine additional outcomes were included in the COS. Sexual problems, an outcome previously excluded, were also added. In total, 30 outcomes were included in the final COS.

We have developed the first COS for future trials of complementary therapies for pwMS. The use of this COS will promote that future research in complementary therapies is relevant for pwMS and other stakeholders involved in MS care. Future COS research should integrate diverse geographical regions, where perspectives and access to complementary therapies may vary.

https://osf.io/ys7xt/.

Although caesarean sections (CSs) are essential for the management of obstructed labour and other obstetric complications, postoperative pain, delayed recovery and complication risks continue to be significant challenges in perioperative management. Improvements in traditional medications and surgical techniques have helped, yet issues, including medication side effects and extended recovery times, persist. Therefore, it is particularly important to seek non-pharmacological interventions, such as acupoint stimulation, to optimise the perioperative management of CS. The aim of this systematic review protocol is to synthesise the available evidence and assess the effect of acupoint stimulation in the perioperative period of CS.

We plan to search PubMed, Web of Science, EMBASE, Scopus, the Cochrane Library and China National Knowledge Infrastructure, from their inception to August 2025. Primary outcome indicators will include pain, time to first defecation, time to first bowel movement and time to return of bowel sounds. Secondary outcome indicators will include postoperative complications, such as nausea and vomiting, bloating, anxiety and depression, as well as length of hospital stay and morphine consumption. Subgroup analyses, meta-regression and sensitivity analyses will be used to investigate the potential sources of heterogeneity and to test the stability of the results. Trial sequential analysis will be introduced to enhance the reliability of the evidence.

No ethical approval is required as this study synthesises the existing published data. Results will be disseminated through peer-reviewed publications and conference presentations. Any protocol amendments will be documented in PROSPERO and detailed in the final publication.

CRD42024558572.