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Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial.

ABSTRACT: BACKGROUND:According to the traditional Chinese medicine theory, moxa floss is the best material for moxibustion; the effect of moxibustion is closely related to the habitats of moxa floss, among which Qichun County, Hubei Province, China, is considered as the genuine origin. However, this view has not been validated by clinical studies. Moxibustion has been proven effective in alleviating pain and improving physical function and quality of life for patients with knee osteoarthritis (KOA). This trial aims to determine whether the habitat of moxa floss contributes to the effect of moxibustion and to validate the effectiveness of moxibustion for KOA. METHODS:This is a three-armed, randomized, double-blinded, sham-controlled trial. A total of 350 patients with moderate to severe primary KOA will be randomly allocated to groups A, B, or C with a 2:2:1 ratio. Moxa stick moxibustion using moxa floss from different habitats will be applied in two experimental groups: group A, moxa floss from the habitat of Qichun County, Hubei Province, China; and group B, moxa floss from the habitat of Nanyang County, Henan Province. Group C will use non-moxa floss for sham moxibustion as control. Patients will be treated for 20 min per session, for three sessions per week for 2 weeks, and followed up for 4 weeks. The primary outcome will be the change from baseline in the pain score of the Western Ontario and McMaster Osteoarthritis Index (WOMAC) at week 2. Secondary outcomes will include a change in the WOMAC pain score at week 6; the visual analogue scale for knee pain, the total WOMAC score, the WOMAC stiffness score, the WOMAC function score, the patient global assessment, and the responder criteria at weeks 2 and 6. Adverse events will be assessed throughout the study. DISCUSSION:This trial will help to identify the effectiveness of moxibustion for KOA and whether the habitat of moxa floss contributes to the effect of moxibustion. TRIAL REGISTRATION:Acupuncture-Moxibustion Clinical Trial Registry: AMCTR-IOR-16000007 . Registered on 29 February 2016.

SUBMITTER: Xu H

PROVIDER: S-EPMC6063012 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial.

Xu Huanfang H Zhao Hong H Kang Liping L Huang Shixi S Shi Yin Y Su Wei W Han Mingjuan M Wang Wenyan W Wang Chunyan C Zhang Yuan Y Guo Lanping L

Trials 20180727 1

<h4>Background</h4>According to the traditional Chinese medicine theory, moxa floss is the best material for moxibustion; the effect of moxibustion is closely related to the habitats of moxa floss, among which Qichun County, Hubei Province, China, is considered as the genuine origin. However, this view has not been validated by clinical studies. Moxibustion has been proven effective in alleviating pain and improving physical function and quality of life for patients with knee osteoarthritis (KOA ...[more]

PMID: 30053899

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Project description:IntroductionKnee osteoarthritis is a common form of arthritis in elderly patients that is characterised by pain and functional limitation. Moxibustion has been employed to relieve chronic pain as an alternative therapy for knee osteoarthritis. However, the evidence of its efficacy is equivocal due to the low methodological quality in most clinical studies. Therefore, we are performing a double-blinded, double-placebo, randomised controlled trial to evaluate the efficacy of moxibustion in participants with knee osteoarthritis.Methods and analysisThis is a multicentre, double-blinded, double-placebo, randomised controlled clinical trial. 144 eligible participants with knee osteoarthritis will be randomly assigned to two different groups in a 1:1 ratio. Participants in the moxibustion group will undergo active moxibustion plus placebo gel, whereas participants in the control group will receive diclofenac sodium gel plus placebo moxibustion. Each participant will receive 12 sessions of active/placebo moxibustion at three acupoints (ST35, ST36 and EX-LE4) as well as 2 months of follow-up. Diclofenac sodium gel or placebo gel at a dose of 4 g per knee will be applied three times per day for 4 weeks. The primary outcome measure will be the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score change at the end of the intervention period from baseline. The secondary outcome measures include changes of other subscales (pain, stiffness and function) of WOMAC, visual analogue scale and patient globalassessment. The safety of moxibustion and diclofenac sodium gel will be assessed at every visit.Ethics and disseminationThis trial has been approved by the Sichuan Regional Ethics Review Committee (permission number: 2015KL-014). The results of this study are expected to provide clinical evidence on the efficacy of moxibustion for pain relief and physical function improvement in patients with knee osteoarthritis. The findings will be submitted for publication in peer-reviewed medical journals and presented at relevant academic conferences.Trial registration numberNCT02769572.

Project description:IntroductionThis study tested the effectiveness of moxibustion on pain and function in chronic knee osteoarthritis (KOA) and evaluated safety.MethodsA multi-centre, non-blinded, parallel-group, randomised controlled trial compared moxibustion with usual care (UC) in KOA. 212 South Korean patients aged 40-70 were recruited from 2011-12, stratified by mild (Kellgren/Lawrence scale grades 0/1) and moderate-severe KOA (grades 2/3/4), and randomly allocated to moxibustion or UC for four weeks. Moxibustion involved burning mugwort devices over acupuncture and Ashi points in affected knee(s). UC was allowed. Korean Western Ontario and McMaster Universities Questionnaire (K-WOMAC), Short Form 36 Health Survey (SF-36v2), Beck Depression Inventory (BDI), physical performance test, pain numeric rating scale (NRS) and adverse events were evaluated at 5 and 13 weeks. K-WOMAC global score at 5 weeks was the primary outcome.Results102 patients (73 mild, 29 moderate-severe) were allocated to moxibustion, 110 (77 mild, 33 moderate-severe) to UC. K-WOMAC global score (moxibustion 25.42+/-SD 19.26, UC 33.60+/-17.91, p<0.01, effect size?=?0.0477), NRS (moxibustion 44.77+/-22.73, UC 56.23+/-17.71, p<0.01, effect size?=?0.0073) and timed-stand test (moxibustion 24.79+/-9.76, UC 25.24+/-8.84, p?=?0.0486, effect size ?=?0.0021) were improved by moxibustion at 5 weeks. The primary outcome improved for mild but not moderate-severe KOA. At 13 weeks, moxibustion significantly improved the K-WOMAC global score and NRS. Moxibustion improved SF-36 physical component summary (p?=?0.0299), bodily pain (p?=?0.0003), physical functioning (p?=?0.0025) and social functioning (p?=?0.0418) at 5 weeks, with no difference in mental component summary at 5 and 13 weeks. BDI showed no difference (p?=?0.34) at 5 weeks. After 1158 moxibustion treatments, 121 adverse events included first (n?=?6) and second degree (n?=?113) burns, pruritus and fatigue (n?=?2).ConclusionsMoxibustion may improve pain, function and quality of life in KOA patients, but adverse events are common. Limitations included no sham control or blinding.Trial registrationClinical Research Information Service (CRIS) KCT0000130.

Project description:BackgroundCurrently, many systematic reviews (SRs) of moxibustion as a treatment of KOA have been published. However, the evidence of different SRs of moxibustion to treat KOA has not been comprehensively evaluated.AimThis overview aimed to evaluate the existing results and provide scientific evidence of the effectiveness and safety of moxibustion in the treatment of KOA.MethodsWe conducted a comprehensive search of Embase, PubMed, Web of Science, Cochrane Library, SinoMed, CNKI, Wanfang, VIP, and other databases until October 31, 2021. A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR-2) was used to assess the methodological quality of SRs. Preferred Reporting Item for Systematic Reviews and Meta-Analyses was used to evaluate the reporting quality, and the risk of bias in SRs was evaluated by ROBIS Tool. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool to determine the strength of evidence and conducted a meta-analysis of the total effectiveness rate.ResultsFinally, 10 qualified SRs were included, including 57 randomized controlled trials and 5,149 participants. All SRs evaluated by AMASTAR-2 had more than one critical deficiency, so all SRs were rated as critically low. In the PRISMA checklist, the manuscript structures of the included SRs were relatively complete. Including four SRs with a low risk of bias and six with a high risk of bias using the ROBIS tool. In GRADE, two items (6.25%) were rated as high quality, three (9.37%) as medium quality, 17 (53.12%) as low quality and 10 (31.25%) as very low quality. A re-meta-analysis showed that moxibustion and moxibustion combined treatment improved the total effectiveness rate in knee osteoarthritis (risk ratio = 1.17, 95% confidence interval 1.13-1.21, P < 0.001 and risk ratio = 1.13, 95% CI: 1.04-1.23, P < 0.001), with low heterogeneity (I 2 = 36.3%, P = 0.020, and I 2 = 0.0%, P = 0.956). A total of eight SRs reported adverse events, and no serious adverse events occurred in the moxibustion group and control group.ConclusionMoxibustion seems to be effective in treating KOA. Four SRs reported 10 common discomfort symptoms caused by moxibustion, and these adverse events can spontaneously subside, even can be avoided, therefore, moxibustion for KOA appears to be safe. However, the reliability of the results is reduced by the high risk of bias of the original studies and the low methodological quality of SRs. Therefore, future studies should pay more attention to the quality of the original study and the evidence quality of the SRs to provide more powerful and scientific evidence of the effectiveness and safety of moxibustion treatment of KOA.

Project description:BackgroundConventional moxibustion is a representative non-drug intervention in traditional Chinese medicine, and it has been reported to produce encouraging results and benefits in relieving symptoms and improving the quality of life for patients with knee osteoarthritis (KOA) in previous clinical trials and systematic reviews. Given that increasing concerns on the safety of generated smoke from conventional moxibustion have received much attention, smoke-free moxibustion is regarded as a potential alternative. However, whether smoke-free moxibustion would display a similar efficacy to that of conventional moxibustion still remains unclear. Therefore, this randomized controlled trial attempts to investigate the difference of efficacy between conventional moxibustion and smoke-free moxibustion in patients with KOA.Methods/designThis is a multicenter, randomized, single-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated to two groups (conventional moxibustion group and smoke-free moxibustion group) in seven hospitals in China. Participants will receive 12 sessions of moxibustion treatment at three acupoints (EX-LE4, ST35, and ST36) over a period of 4 weeks (3 sessions per week). A smoke-removing device is placed at the top of the moxibustion device for the smoke-free moxibustion group (n = 69), while the conventional moxibustion group (n = 69) is treated with traditional moxibustion. The primary outcome measure will be the change of the global scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from the baseline to 4 weeks. Secondary outcomes include the visual analog scale VASand Patient Global Assessment scores. Follow-up measurements will be performed on the 8th and 12th weeks after random allocation.DiscussionThis study will contribute to providing a solid foundation for the selection of moxibustion in clinical application as well as future research in moxibustion therapy.Trial registrationClinicalTrials.gov, NCT02772055 . Registered on 12 May 2016.

Dataset Information

Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial.

Publications

Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial.

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