Osteonecrosis of the femoral head (ONFH) is a progressive and disabling condition, with pain being its predominant symptom. Electroacupuncture (EA) has shown promise in the management of chronic pain; however, high-quality evidence on its efficacy and safety in ONFH is still lacking. The aim of this trial is to evaluate the efficacy and safety of EA for pain relief in ONFH.
This triple-blind, sham-controlled, parallel-group randomised controlled trial will be conducted at a single centre in China and will include 176 participants with ONFH. Participants will be randomly allocated (1:1) to receive either active EA or sham EA. The active intervention involves EA applied to specific acupoints (GB30, GB29, ST31, BL54 and Ashi points) twice weekly for 4 weeks. Sham EA consists of superficial needling at non-acupoint locations using a deactivated device. The primary outcome is the proportion of patients achieving a clinically meaningful reduction in pain at 4 weeks (end of treatment). Secondary outcomes are changes in the Visual Analogue Scale score, the proportion of participants achieving clinically significant pain improvement at weeks 8, 12 and 16, modified Harris Hip Score, psychological scales (Patient Health Questionnaire-9, Generalised Anxiety Disorder-7, Pain Catastrophising Scale, Pain Self-Efficacy Questionnaire), the 12-Item Short Form Health Survey, pain sensitisation tests, rescue analgesic use and the incidence of adverse events. Data will be analysed using the intention-to-treat principle, and appropriate statistical models will be used to compare the primary outcome between groups.
Ethical approval has been obtained from the Luoyang Orthopedic Hospital of Henan Province (Approval No: 2025ZXKT0001-02). Written informed consent will be obtained from all participants prior to enrolment. The results of this trial will be disseminated regardless of the findings through publication in a peer-reviewed journal.
Accessible, person-centred, non-pharmacologic modalities are needed to address chronic pain and health-related quality of life (HRQoL) among individuals with sickle cell disease (SCD). Building off prior single-site pilot studies of music therapy (MT) in SCD, the purpose of this study is to (1) examine the data collection processes and intervention implementation overall and across two sites and (2) evaluate the implementation of the MT and health education interventions using quantitative and qualitative data.
This three-arm, two-site, feasibility randomised controlled trial will include 90 individuals ≥14 years who have SCD, chronic pain and access to a mobile device who are not currently engaged in mind-body pain management interventions under the supervision of a healthcare professional. Participants will be randomised to six sessions over 8 weeks of either: (1) in-person MT, (2) hybrid (one in-person, five virtual) MT or (3) hybrid health education. Patient-reported outcome measures of HRQoL and self-efficacy will be assessed at baseline, post-intervention and 6 weeks post-intervention. 24 participants (eight per arm) and 20 stakeholders (eg, haematologists, music therapists, nurses) will be invited to complete semi-structured interviews to further examine intervention acceptability, perceived benefits and implementation. Sessions will be monitored for fidelity, and participants lacking access to home internet or videoconferencing technology will be provided tablets to engage in virtual sessions. Feasibility will be determined by rates of data completion, recruitment, retention, session attendance and home practice.
This study was approved by the University Hospitals Cleveland Medical Center Institutional Review Board (STUDY20231055). The dissemination plan includes presenting findings at national and international scientific conferences and publishing in peer-reviewed journals. All activities will be conducted in collaboration with SCD community stakeholders.
Postoperative pain is common after surgery, with a high incidence and risk of becoming chronic. Current multimodal analgesia has drawbacks, including limited efficacy from single agents and opioid side effects and addiction risk. These issues have led to opioid-sparing multimodal analgesia. Transcutaneous auricular vagus nerve stimulation (taVNS) is non-invasive and convenient. Studies have shown it can reduce postoperative pain, improve mood and lower adverse events. However, taVNS lacks a comprehensive evaluation and standardised protocols, so further research is needed to provide reliable evidence.
This study strictly adheres to the guidelines of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. To identify suitable randomised controlled trials (RCTs), eight credible databases will be searched, including four English databases (Web of Science, PubMed, Cochrane Central Register of Controlled Trials, EMBASE) and four Chinese databases (China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals, Wanfang Database, Chinese Biomedical Literature Database). RevMan V.5.3 will be employed to integrate the retrieved data and conduct meta-analyses. The methodological quality of included RCTs will be evaluated using the Cochrane Risk of Bias Assessment 2.0 tool. Additionally, the Grading of Recommendations, Assessment, Development and Evaluation system will be applied to assess the strength and certainty of the evidence. We will also conduct publication bias analyses, sensitivity analyses and subgroup analyses.
No ethical review is required as no private or confidential patient data will be included. Results of this study will be disseminated through a peer-reviewed journal.
CRD420251207651.
Hand dysfunction following stroke, especially during the flaccid paralysis phase, significantly impairs patients’ motor abilities and daily functioning. Electroacupuncture (EA) is widely used in post-stroke rehabilitation; however, inconsistent clinical outcomes and lack of standardised treatment parameters have limited its broader adoption.
This protocol describes a randomised controlled trial designed to determine optimal EA parameters for post-stroke hand dysfunction using an orthogonal experimental design.
This protocol presents a single-centre, randomised controlled trial design with 10 arms. A total of 110 patients with post-stroke hand dysfunction will be randomly assigned to nine electroacupuncture groups or one sham acupuncture group in equal proportions. Participants will receive 12 treatment sessions over 2 weeks. The EA groups are designed based on a four-factor, three-level orthogonal design to systematically evaluate the main effects of acupoint selection, stimulation frequency, needle thickness and treatment duration. The primary outcome is the effective response rate, defined as reduction in the Chinese Stroke Scale (CSS) score at 2 weeks. Secondary outcomes include assessments with the Modified Lindmark Rating Scale, range of motion measures, Modified Barthel Index and hand motor subscores of the CSS. As this is a trial protocol, results are not yet available. Statistical analyses will be conducted after completion of recruitment and follow-up according to the prespecified analysis plan. Safety and adverse events will be monitored throughout the study.
This trial is designed to address the current lack of evidence-based standardisation of EA parameters for post-stroke hand dysfunction. By systematically evaluating key treatment components using an orthogonal experimental design, the study aims to identify optimal EA strategies and provide a methodological framework to improve consistency, reproducibility and clinical effectiveness in post-stroke hand rehabilitation.
This manuscript describes a study protocol and does not report any data from participants at this stage. Ethical approval for the planned trial was obtained from the Medical Ethics Committee of the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (Approval No. TYLL2024(K)072). Written informed consent will be obtained from all participants prior to enrolment. The results of the study will be disseminated through peer-reviewed journals and academic conferences.
ITMCTR2024000819.
Research indicates that most individuals will experience at least one traumatic event in their lifetime. Some individuals may develop post-traumatic stress disorder, while others may exhibit subclinical levels of post-traumatic stress disorder symptoms alongside comorbid conditions such as depression and anxiety. As a body-based adjunctive intervention, trauma-informed yoga is increasingly used to mitigate post-traumatic stress disorder symptoms in individuals who have experienced trauma, including those with or without a formal post-traumatic stress disorder diagnosis. However, the efficacy of this approach remains a topic of contention in published studies.
To identify relevant trials, a literature search will be conducted across seven electronic databases. We will include randomised controlled trials and pre-post studies that assess trauma-informed yoga in trauma-exposed adults. Data obtained from these sources will be synthesised and analysed meta-analytically using RevMan 5.4. The primary outcome measure will be the total score of post-traumatic stress disorder symptoms, while secondary outcome measures will encompass anxiety and depression scores. The methodological quality and risk of bias of the included trials will be evaluated using the 12-item National Institutes of Health quality assessment tool and the revised Cochrane Risk of Bias tool (version 2). Furthermore, the overall strength of the evidence will be rated according to the Grading of Recommendations, Appraisals, Developments and Evaluations framework.
No formal research ethics approval is required. The results will be submitted for publication in a peer-reviewed journal.
CRD420251113495.
Postoperative ileus (POI) is a prevalent complication following abdominal surgeries, significantly compromising patients’ quality of life and imposing a socioeconomic burden. Electroacupuncture (EA), a widely used therapeutic approach in China, has shown promise as an effective intervention for POI. However, the neural mechanism underlying its therapeutic effects remains unclear. Thus, this study aims to evaluate the efficacy of EA treatment for POI and investigate its central mechanism by functional MRI (fMRI).
This randomised controlled clinical trial will be conducted across three hospitals in China. A total of 50 eligible patients with colorectal cancer scheduled for elective laparoscopic surgery will be randomly assigned to either the EA or sham electroacupuncture (SA) group in a 1:1 ratio. All patients will undergo 5 sessions of 30 min EA or SA over 5 consecutive days post-surgery (once daily). Resting-state fMRI (rs-fMRI) scans will be performed at baseline and the end of treatment to examine brain functional changes related to EA treatment. The primary outcome is the time to first defecation. Secondary outcomes include the time to first flatus, ambulation, tolerability of semiliquid and solid food; length of postoperative hospital stay; severity of postoperative pain, abdominal distension and nausea; frequency of postoperative nausea and vomiting episodes; rate of readmission. Postoperative complications will be monitored and documented throughout the trial duration. Credibility and expectancy evaluation, along with blinding assessment, will be conducted after the first treatment session. Pearson/Spearman correlation analysis will be performed to determine the relationship between clinical variables and rs-fMRI metrics.
This protocol has been approved by the ethics committees of Beijing University of Chinese Medicine (number 2024BZYLL0113), Cancer Hospital Chinese Academy of Medical Sciences (number 24/323-4603), Beijing Friendship Hospital Affiliated to Capital Medical University (number 2024-P2-081-01) and Beijing Chaoyang Huanxing Cancer Hospital (number 2024-011-02). Participants will sign the paper-based informed consent form before enrolment. The results will be disseminated through peer-reviewed publications.
ITMCTR2024000504.
While numerous evidence-based studies have been conducted on procedure-based treatments (PBTs) in traditional, complementary and integrative medicine (TCIM) (eg, acupuncture, special diets, lifestyle modification, yoga, Tai ), high-quality research reports accepted by the academic community remain scarce. Key factors contributing to the low evidence quality in this field include researchers’ insufficient grasp of clinical research methodology concepts, inadequate study designs and lack of pilot studies. Scholars now widely recognise that establishing a robust evaluation framework for PBTs in TCIM is crucial for progressively refining research protocols and advancing clinical practice. Therefore, this scoping review aims to systematically map current evaluation methods for PBTs in TCIM, analyse their critical procedural components and lay the groundwork for developing a tailored evaluation framework.
Forty-three databases will be systematically searched using comprehensive search strategies. Two independent reviewers will screen potential literature and select eligible studies. Literature management will be performed using NoteExpress and Excel 2016, with a pre-designed standardised Excel sheet employed for data extraction.
This scoping review will include literature that provides multidimensional evaluation (eg, efficacy, safety and health economics) for PBTs in TCIM. This encompasses methodological guidelines, systematic protocols outlining evaluative structures, procedural steps and core components, as well as conceptual or theoretical frameworks describing phased evaluation processes. Screening and data extraction will be conducted independently by two researchers. Inter-rater agreement will be assessed using the Kappa statistic. Any discrepancies will be resolved through consultation with a senior reviewer or correspondence with original authors.
Data extraction will capture: general information, types and number of included primary studies, interventions assessed, evaluation dimensions, procedural workflows for evaluation, version iterations of evaluation frameworks, staging configurations for evaluation, framework development methods, as well as documented strengths and limitations of the frameworks.
Results will be structured following the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist. Findings will be presented through tables, charts and figures, with narrative synthesis describing key outcomes.
No private information was issued in the entire process of the systematic review. Therefore, ethical approval is not required. Findings of the scoping review will be published in a peer-reviewed journal and/or disseminated through conference presentations.
The protocol has been archived in the Open Science Framework (Registration DOI: https://doi.org/10.17605/OSF.IO/92DRM).
Chronic insomnia is a pressing public health issue that significantly affects patients’ quality of life. In China, Prolong Life With Nine Turn-Method (PLWNT) Qigong exercise has long been used to improve sleep quality, yet evidence that supports its efficacy for chronic insomnia treatment remains lacking. The aim of this study is to evaluate the effectiveness and safety of the PLWNT qigong exercise for treating chronic insomnia and its relationship with hyperarousal.
This multi-centre randomised controlled trial will recruit 348 eligible patients from three hospitals in Shanghai. Participants will be randomly assigned to either the treatment group (PLWNT qigong exercise) or the control group (cognitive behavioural therapy). The treatment will occur once a week for 12 weeks, followed by an 8-week follow-up phase. The primary outcome is the change in the total Pittsburgh Sleep Quality Index (PSQI) score from baseline to week 12. The secondary outcomes are the scores on the Hyperarousal Scale (HAS), Insomnia Severity Index (ISI), Multidimensional Fatigue Inventory 20 (MFI-20), Hospital Anxiety and Depression (HADS), Medical Outcome Trust 36–Item Short Form Health Survey (SF–36) and Gastrointestinal Symptom Rating Scale (GSRS), gut microbiota, actigraphy, sleep diary, cortisol, adrenocorticotrophic hormone, corticotropin-releasing hormone, polysomnography and functional MRI. All adverse events during the trial will be promptly recorded and assessed. The PSQI, HAS, ISI, MFI-20, HADS, SF–36 and GSRS will be evaluated at baseline, 6 weeks post-treatment and 12 weeks post-treatment, as well as at the 4- week and 8- week follow-ups. Other outcomes will only be evaluated at baseline and 12 weeks post-treatment.
The trial has been approved by the Ethics Committee of the Shanghai Municipal Hospital of Traditional Chinese Medicine (2024SHL-KY-92–01). Written informed consent was obtained from all participants before their involvement in the trial. Results of this study will be published in peer-reviewed journals or at conferences.
ITMCTR2024000534.
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.
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.