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: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 … Show more
“…One RCT 21 revealed that the participants with moxibustion experienced a considerably significant improvement in a GH score than the control group at week 6 ( P = 0.015) and week 12 ( P = 0.029); the same result applied to the VT score at week 12 ( P = 0.042). The other study 23 reported that the BP score, PF score, or SF score in the patients with moxibustion were separately higher than those scores of the patients in the control group ( P = 0.0003 at week 5, 13; P = 0.0025 at week 5; and P = 0.0418 at week 5). The data in all of the subcategories of the SF-36 scale were quantitatively synthesized in the meta-analysis.…”
Section: Resultsmentioning
confidence: 79%
“…Otherwise, 3 RCTs 20,21,23 noted region adverse reactions, for example, blisters, burn wounds, and skin flushing in local lesions. Two studies 21,23 reported systemic AEs; however, only 1 23 reported positive symptoms, that is, pruritus and fatigue.…”
“…One RCT 21 revealed that the participants with moxibustion experienced a considerably significant improvement in a GH score than the control group at week 6 ( P = 0.015) and week 12 ( P = 0.029); the same result applied to the VT score at week 12 ( P = 0.042). The other study 23 reported that the BP score, PF score, or SF score in the patients with moxibustion were separately higher than those scores of the patients in the control group ( P = 0.0003 at week 5, 13; P = 0.0025 at week 5; and P = 0.0418 at week 5). The data in all of the subcategories of the SF-36 scale were quantitatively synthesized in the meta-analysis.…”
Section: Resultsmentioning
confidence: 79%
“…Otherwise, 3 RCTs 20,21,23 noted region adverse reactions, for example, blisters, burn wounds, and skin flushing in local lesions. Two studies 21,23 reported systemic AEs; however, only 1 23 reported positive symptoms, that is, pruritus and fatigue.…”
“…12,26 However, the adverse effects of moxa smoke restrict the development of traditional moxibustion. 27,28 In recent years, our group has developed a 10.6 lm laser moxibustion apparatus. The infrared radiation spectrum of traditional indirect moxibustion and human acupoints are very similar, and their radiation peaks are about 10 lm, which may produce resonance, playing a therapeutic role.…”
Background: Although chronic pain affects the quality of life of patients with osteoarthritis, current medical treatments are either ineffective or have long-term side effects. Recently, low-intensity laser irradiation of corresponding acupoints was demonstrated to alleviate pain. Objective: The aim of the present study was to investigate the effects of 10.6 lm laser moxibustion on a monosodium iodoacetate (MIA)-induced knee osteoarthritis pain model. Methods: Thirty-two rats were randomly assigned to four groups: Saline, MIA, MIA+Laser, and MIA+Sham Laser. The 10.6 lm laser was used to irradiate the ST35 for 10 min once a day for a total of seven applications. The paw withdrawal mechanical threshold and weight-bearing difference were performed to evaluate the analgesic effects of laser moxibustion. At the end of the experiment on days 28, the joint histology, the levels of metalloproteinases-13 (MMP-13) in the cartilage, and TNF-a, IL-1b, and IL-6 in the synovial membrane were measured to determine the chondroprotection and anti-inflammatory effect of laser moxibustion. Results: Early laser moxibustion significantly reversed the MIA-induced mechanical hyperalgesia and weightbearing difference, especially on the 28th day (p < 0.001). Moreover, laser moxibustion prevented the articular pathological lesions and cartilage destruction on days 28 (p < 0.01). Remarkably, the levels of cartilage MMP-13, and synovial TNF-a, IL-1b, and IL-6 also decreased on day 28 (p < 0.05) after the early treatment of laser moxibustion. Conclusions: 10.6 lm laser moxibustion may have long-lasting analgesic, anti-inflammatory, and chondroprotection effects, suggesting that it may emerge as a potential therapeutic strategy for the chronic pain treatment of osteoarthritis.
“…Sample size was estimated as described previously [19], which considered a change in the population mean on the numerical rating scale (NRS) for each group (1, EM group; 2, TIM group; 3, usual care group). The null and alternative hypotheses are:…”
Section: Methodsmentioning
confidence: 99%
“…Treatments will be provided bilaterally in participants with pain in both knees. The treatment acupoints were selected based on a consensus of doctors of traditional Korean medicine, a text book, literature reviews, and additional studies [10, 19, 20]. The participants will be asked to wear loose clothing for easy exposure of the knee joints, and to maintain a comfortable supine position during treatment.Fig.…”
BackgroundKnee 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.MethodsThis 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.DiscussionThis trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA.Trial registrationClinicalTrials.gov, NCT03287570. Registered on 19 September 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2514-x) contains supplementary material, which is available to authorized users.
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