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

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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

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Most cited references 18

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Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines.

TJ Schnitzer, KD Brandt, MC Hochberg … (2000)

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Core outcome domains for chronic pain clinical trials: IMMPACT recommendations.

James Witter, Jeffrey Katz, Carolyn Kramer … (2003)

To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of data, encourage more complete reporting of outcomes, simplify the preparation and review of research proposals and manuscripts, and allow clinicians to make informed decisions regarding the risks and benefits of treatment. Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 27 specialists from academia, governmental agencies, and the pharmaceutical industry participated in a consensus meeting and identified core outcome domains that should be considered in clinical trials of treatments for chronic pain. There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events, (6) participant disposition (e.g. adherence to the treatment regimen and reasons for premature withdrawal from the trial). Although consideration should be given to the assessment of each of these domains, there may be exceptions to the general recommendation to include all of these domains in chronic pain trials. When this occurs, the rationale for not including domains should be provided. It is not the intention of these recommendations that assessment of the core domains should be considered a requirement for approval of product applications by regulatory agencies or that a treatment must demonstrate statistically significant effects for all of the relevant core domains to establish evidence of its efficacy.

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Is obesity a risk factor for progressive radiographic knee osteoarthritis?

J Niu, Y. Q. Zhang, J. Torner … (2009)

To examine whether obesity increases the risk of progression of knee osteoarthritis (OA). We used data from the Multicenter Osteoarthritis Study, a longitudinal study of persons with or at high risk of knee OA. OA was characterized at baseline and 30 months using posteroanterior fixed-flexion radiographs and Kellgren/Lawrence (K/L) grading, with alignment assessed on full-extremity films. In knees with OA at baseline (K/L grade 2 or 3), progression was defined as tibiofemoral joint space narrowing on the 30-month radiograph. In knees without OA at baseline (K/L grade 0 or 1), incident OA was defined as the development of radiographic OA at 30 months. Body mass index (BMI) at baseline was classified as normal ( or=35 kg/m(2)). The risk of progression was tested in all knees and in subgroups categorized according to alignment. Analyses were adjusted for age, sex, knee injury, and bone density. Among the 2,623 subjects (5,159 knees), 60% were women, and the mean +/- SD age was 62.4 +/- 8.0 years. More than 80% of subjects were overweight or obese. At baseline, 36.4% of knees had tibiofemoral OA, and of those, only one-third were neutrally aligned. Compared with subjects with a normal BMI, those who were obese or very obese were at an increased risk of incident OA (relative risk 2.4 and 3.2, respectively [P for trend < 0.001]); this risk extended to knees from all alignment groups. Among knees with OA at baseline, there was no overall association between a high BMI and the risk of OA progression; however, an increased risk of progression was observed among knees with neutral but not varus alignment. The effect of obesity was intermediate in those with valgus alignment. Although obesity was a risk factor for incident knee OA, we observed no overall relationship between obesity and the progression of knee OA. Obesity was not associated with OA progression in knees with varus alignment; however, it did increase the risk of progression in knees with neutral or valgus alignment. Therefore, weight loss may not be effective in preventing progression of structural damage in OA knees with varus alignment.

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Author and article information

Contributors

D. William Cameron: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, USA )

ISSN (Electronic): 1932-6203

Publication date Collection: 2014

Publication date (Electronic): 25 July 2014

Volume: 9

Issue: 7

Affiliations

[1 ]Korea Institute of Oriental Medicine, Dae-Jeon, South Korea

[2 ]College of Korean medicine, Gachon University, Seongnam, South Korea

[3 ]Department of Acupuncture & Moxibustion, Korean medicine hospital, Pusan National University, Yangsan, South Korea

[4 ]Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung-Hee University, Seoul, South Korea

[5 ]Kyungwon University Incheon Gill Oriental Medical Hospital, Incheon, South Korea

[6 ]Semyung University Jecheon Oriental Medical Hospital, Jecheon, South Korea

[7 ]Dongshin University Gwangju Oriental Hospital, Gwangju, South Korea

[8 ]Department of Acupuncture and Moxibustion, Daejeon University, Daejeon, South Korea

University of Ottawa, Canada

Author notes

* E-mail: smchoi@ 123456kiom.re.kr

Competing Interests: The authors have declared that no competing interests exist.

Conceived and designed the experiments: THK KHK. Performed the experiments: THK KHK JWK MHL KWK JEK SHL MSS SYJ ARK HJP HJJ HSS JHK JBC HJK KEH SMC. Analyzed the data: MHL. Wrote the paper: THK. Study monitoring: HJJ.

Article

Publisher ID: PONE-D-13-32894

DOI: 10.1371/journal.pone.0101973

PMC ID: 4111481

PubMed ID: 25061882

SO-VID: 9d74d2f9-2461-4569-b865-f834e3688e87

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Page count

Pages: 8

Funding

This study was supported by the “Development of Acupuncture, Moxibustion and Meridian Standard Health Technology” project of the Korea Institute of Oriental Medicine (K12010). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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

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Abstract

Introduction

Methods

Results

Conclusions

Trial Registration

Related collections

PLOS: COVID-19 pandemic

Most cited references 18

Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines.

Core outcome domains for chronic pain clinical trials: IMMPACT recommendations.

Is obesity a risk factor for progressive radiographic knee osteoarthritis?

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