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      Moxibustion for treating knee osteoarthritis: study protocol of a multicentre randomised controlled trial


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          The treatment of knee osteoarthritis, which is a major cause of disability among the elderly, is typically selected from multidisciplinary options, including complementary and alternative medicine. Moxibustion has been used in the treatment of knee osteoarthritis in Korea to reduce pain and improve physical activity. However, there is no sufficient evidence of its effectiveness, and it cannot therefore be widely recommended for treating knee osteoarthritis. We designed a randomised controlled clinical trial to evaluate the effectiveness, safety, cost-effectiveness, and qualitative characteristics of moxibustion treatment of knee osteoarthritis compared to usual care.


          This is a protocol for a multicentre, pragmatic, randomised, assessor-blinded, controlled, parallel-group study. A total of 212 participants will be assigned to the moxibustion group (n = 106) and the usual care group (n = 106) at 4 clinical research centres. The participants assigned to the moxibustion group will receive moxibustion treatment of the affected knee(s) at 6 standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04, and SP10) 3 times per week for 4 weeks (a total of 12 sessions). Participants in the usual care group will not receive moxibustion treatment during the study period. Follow-up will be performed on the 5th and 13th weeks after random allocation. Both groups will be allowed to use any type of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs, and other active treatments. Educational material that explains knee osteoarthritis, the current management options, and self-exercise will be provided to each group. The global scale of the Korean Western Ontario and McMaster Osteoarthritis Index (K-WOMAC) will be the primary outcome measurement used in this study. Other subscales (pain, stiffness, and function) of the K-WOMAC, the Short-Form 36v2 Health Survey, the Beck Depression Inventory, the Physical Function test, Patient Global Assessment, and the Pain Numerical Rating Scale will be used as outcome variables to evaluate the effectiveness of moxibustion. Safety will be assessed at every visit. In addition, an economic evaluation and a qualitative study will be conducted as a mixed-methods approach.


          This trial may contribute to developing evidence for the effectiveness and safety of moxibustion for treating knee osteoarthritis.

          Trial registration

          Trial registration number: KCT0000130

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          Most cited references22

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          Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care.

          Osteoarthritis is the single most common cause of disability in older adults, and most patients with the condition will be managed in the community and primary care. To discuss case definition of knee osteoarthritis for primary care and to summarise the burden of the condition in the community and related use of primary health care in the United Kingdom. Narrative review. A literature search identified studies of incidence and prevalence of knee pain, disability, and radiographic osteoarthritis in the general population, and data related to primary care consultations. Findings from UK studies were summarised with reference to European and international studies. During a one year period 25% of people over 55 years have a persistent episode of knee pain, of whom about one in six in the UK and the Netherlands consult their general practitioner about it in the same time period. The prevalence of painful disabling knee osteoarthritis in people over 55 years is 10%, of whom one quarter are severely disabled. Knee osteoarthritis sufficiently severe to consider joint replacement represents a minority of all knee pain and disability suffered by older people. Healthcare provision in primary care needs to focus on this broader group to impact on community levels of pain and disability.
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            Psychometric properties of the credibility/expectancy questionnaire.

            The present research evaluated the psychometric properties of the credibility/expectancy questionnaire, a quick and easy-to-administer scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies. The results suggested that this questionnaire derives the two predicted factors (cognitively based credibility and relatively more affectively based expectancy) and that these factors are stable across different populations. Furthermore, the questionnaire demonstrated high internal consistency within each factor and good test-retest reliability. The expectancy factor predicted outcome on some measures, whereas the credibility factor was unrelated to outcome. The questionnaire is appended to the paper, yet the authors stress care when utilizing the scale. During the administration of the questionnaire, the participant sees two sections--one related to thinking and one related to feeling. However, the researcher needs to be aware that the 2 factors derived are not grouped into those questions. Instead credibility was found to be derived from the first three think questions and expectancy was derived from the fourth think question and the two feel questions.
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              Pragmatic clinical trials.

              Both pragmatic and explanatory randomised controlled trials have a useful role to play in the evaluation of health care interventions. In this descriptive article, the key steps in conducting a pragmatic trial are described. The strengths and limitations of pragmatic trials are also discussed. The main strength of pragmatic trials is that they can evaluate a therapy as it is used in normal practice. Comparisons are made between pragmatic and explanatory trials, on the understanding that trials may have aspects to them that make the trial more of a hybrid. A case is made for the appropriate use and relevance of pragmatic trials in the evaluation of alternative and complementary medicine.

                Author and article information

                BMC Complement Altern Med
                BMC Complement Altern Med
                BMC Complementary and Alternative Medicine
                BioMed Central
                13 March 2013
                : 13
                : 59
                [1 ]Acupuncture, Moxibustion & Meridian Research Group, Medical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea
                [2 ]Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, South Korea
                [3 ]Department of Acupuncture & Moxibustion Medicine, Korean Medicine Hospital, Pusan National University, Pusan, South Korea
                [4 ]Mokhuri Neck and Back Hospital, Seoul, South Korea
                [5 ]Department of Acupuncture & Moxibustion, College of Oriental Medicine, Daejeon University, Daejeon, South Korea
                [6 ]Department of Acupuncture & Moxibustion, College of Oriental Medicine, Gachon University, Incheon, South Korea
                [7 ]Department of Oriental Rehabilitation Medicine, College of Oriental Medicine, Dong-Shin University, Gwangju, South Korea
                [8 ]Department of Oriental Gynaecology, College of Oriental Medicine, Se-Myung University, Jecheon, South Korea
                Copyright ©2013 Lee et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                Study Protocol

                Complementary & Alternative medicine
                Complementary & Alternative medicine


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