Dataset Information

Moxibustion treatment for knee osteoarthritis: a multi-centre, non-blinded, randomised controlled trial on the effectiveness and safety of the moxibustion treatment versus usual care in knee osteoarthritis patients.

ABSTRACT:

Introduction

This study tested the effectiveness of moxibustion on pain and function in chronic knee osteoarthritis (KOA) and evaluated safety.

Methods

A 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.

Results

102 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).

Conclusions

Moxibustion may improve pain, function and quality of life in KOA patients, but adverse events are common. Limitations included no sham control or blinding.

Trial registration

Clinical Research Information Service (CRIS) KCT0000130.

SUBMITTER: Kim TH

PROVIDER: S-EPMC4111481 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Publications

Moxibustion treatment for knee osteoarthritis: a multi-centre, non-blinded, randomised controlled trial on the effectiveness and safety of the moxibustion treatment versus usual care in knee osteoarthritis patients.

Kim Tae-Hun TH Kim Kun Hyung KH Kang Jung Won JW Lee MinHee M Kang Kyung-Won KW Kim Jung Eun JE Kim Joo-Hee JH Lee Seunghoon S Shin Mi-Suk MS Jung So-Young SY Kim Ae-Ran AR Park Hyo-Ju HJ Jung Hee-Jung HJ Song Ho Sueb HS Kim Hyeong Jun HJ Choi Jin-Bong JB Hong Kwon Eui KE Choi Sun-Mi SM

PloS one 20140725 7

<h4>Introduction</h4>This study tested the effectiveness of moxibustion on pain and function in chronic knee osteoarthritis (KOA) and evaluated safety.<h4>Methods</h4>A 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 ...[more]

PMID: 25061882

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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:BACKGROUND:Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. METHODS:This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of "ashi", if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. DISCUSSION:This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03287570 . Registered on 19 September 2017.

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:BackgroundDegenerative knee osteoarthritis (KOA) shows an increase in morbidity with improvement in the living conditions and extended lifespans. Treatment for degenerative KOA has been gaining attention since it significantly affects the life of the elderly population and is also associated with increased expenses for medical services and high socioeconomic costs. Treatments for degenerative KOA include nondrug therapy, drug therapy, and surgical treatment. For cases that show little response to conservative treatment but have not involved severe deformation of the knee, procedures such as arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation can be performed. However, effective treatment is required for patients experiencing sustained knee pain after surgery. Although studies confirming the therapeutic effects of acupuncture or thread-embedding acupuncture (TEA) treatment for degenerative KOA have been reported, clinical studies on a combination of TEA and electroacupuncture (EA) in patients complaining of knee pain after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation have not yet been reported. Therefore, this study aimed to evaluate the effectiveness and safety of this combination treatment in patients with persistent knee pain after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation.Methods/designThis study has been designed as a 2-group, parallel, single-center, randomized, controlled, assessor-blinded trial. Thirty-six patients with degenerative KOA who complained of pain even after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation will be randomized to either the (TEA + EA + Usual care) group or the (Usual care only) group in a 1:1 ratio. The patients in the (TEA + EA + Usual care) group will receive TEA treatment once a week for 4 weeks for a total of 4 sessions and EA twice a week for a total of 8 sessions while continuing usual care. The (Usual care only) group will only receive usual care for 4 weeks. To assess the efficacy of the TEA and EA combination treatment, the visual analogue scale, the Korean version of the Western Ontario and McMaster Universities Osteoarthritis Index, the EuroQol 5-Dimension 5-Level, and the doses of the rescue drug taken will be evaluated at baseline (1W) and weeks 2 (2W), 4 (4W), 6 (6W), and 8 (8W). The primary efficacy endpoint is the mean change in visual analogue scale at week 4 (4W) compared to baseline. Adverse events will be assessed at every visit.DiscussionThis study will provide useful data for evaluating the clinical efficacy and safety of TEA and electroacupuncture combination treatment for improving pain and quality of life after surgery for degenerative KOA.Trial registrationClinical Research Information Service of Republic of Korea (CRIS- KCT0004804), March 6, 2020.

Dataset Information

Moxibustion treatment for knee osteoarthritis: a multi-centre, non-blinded, randomised controlled trial on the effectiveness and safety of the moxibustion treatment versus usual care in knee osteoarthritis patients.

Introduction

Methods

Results

Conclusions

Trial registration

Publications

Moxibustion treatment for knee osteoarthritis: a multi-centre, non-blinded, randomised controlled trial on the effectiveness and safety of the moxibustion treatment versus usual care in knee osteoarthritis patients.

Similar Datasets

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