Efficacy of Moxibustion Therapy With or Without Smoke for Knee Osteoarthritis

Study Overview
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Brief Summary
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This is a multicentre, randomised, single blinded, parallel-group design clinical trial to assess the effect of moxa smoke in the treatment using moxibustion for Knee Osteoarthritis.

Detailed Description
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Aim: To assess the effect of moxa smoke in the treatment using moxibustion for knee osteoarthritis. Design: This is a multicentre, randomised, single blinded, parallel-group design clinical trial. 138 eligible participants will be randomly allocated into 2 groups (moxibustion group or smoke-free moxibustion group) with a 1:1 allocation ratio, and receive 12 sessions of moxibustion treatment over a period of 4 weeks, three sessions per week. Each session will last 30 minutes. The whole study period is 13 weeks, with a 1 week run in period, 4 week treatment phase, and 8 week follow-up phase.The participants will receive moxibustion treatment at three acupoints (EX-LE04,ST35,ST36). In moxa-free smoke moxibustion group, investigators place a purification device(Shenzhen Conyson Electronic Technology Co, Ltd,C200 moxa smoke purification device,Shenzhen,China) at the top of the moxibustion to remove the moxa smoke. The primary measurement outcomes are the mean change in the global scale value of the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) pain and function scores from baseline to 4 weeks. The secondary outcomes are the Visual Analogue Scale (VAS) and the patient global assessment. Investigators will assess participants at the second visit (before starting moxibustion treatment) and at the 2, 4, 8, and 12 week respectively after the baseline.

Official Title
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A Multicentre, Randomised, Single Blinded, Parallel-group Study of Moxa Smoke Effect in Moxibustion Treating Knee Osteoarthritis

Conditions
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Pain

Intervention / Treatment
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* Other: Moxibustion
* Other: Moxa smoke purification device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants meeting the following criteria will be included: aged between 40 and 75 years diagnosed with knee osteoarthritis formulated by the American College of Rheumatology (ACR). the average severity of knee pain not more than 7 points on a visual analogue scale for most days during the past month agree not have the paregoric during the whole treatment phase willingness to participate in a randomized study and to sign the informed consent form. Exclusion Criteria: Participants will be excluded if they have these experiences: inflammatory diseases, including rheumatoid arthritis, cancer, traumatic injury that might be related to the current knee pai autoimmune disease, uncontrolled hypertension diabetes mellitus requiring insulin injection life-threatening cardiovascular or neurological events within the past year chronic respiratory disease,a haemorrhagic disorder alcohol or drug addiction an active infectious disease including tuberculosis a significant knee joint deformity knee replacement surgery for the affected knee knee arthroscopy within the past year steroid injection in the knee joints within the past 3 months injections in the knee joints or joint fluid injection within the past 6 months accept acupuncture, moxibustion, cupping, or herbal medicine within the past 4 weeks

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: moxibustion group<br>Conventional moxibustion treatment for knee osteoarthritis participants.12 sessions of moxibustion treatment over a period of 4 weeks, 3 sessions per week.Each session will last 30 minutes. | Other: Moxibustion<br>* Moxibustion at three acupuncture point(EX-LE04,ST35,ST36).12 sessions of moxibustion treatment over a period of 4 weeks, 3 sessions per week.Each session will last 30 minutes.<br>|
| Experimental: smoke-free moxibustion group<br>Conventional moxibustion treatment for knee osteoarthritis participants and have a purification device at the top of the moxibustion to remove the moxa smoke.12 sessions of moxibustion treatment over a period of 4 weeks, 3 sessions per week.Each session will last 30 minutes. | Other: Moxibustion<br>* Moxibustion at three acupuncture point(EX-LE04,ST35,ST36).12 sessions of moxibustion treatment over a period of 4 weeks, 3 sessions per week.Each session will last 30 minutes.<br>Other: Moxa smoke purification device<br>* Investigators place a purification device(Shenzhen Conyson Electronic Technology Co, Ltd,C200 moxa smoke purification device,Shenzhen,China) at the top of the moxibustion to remove the moxa smoke.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the global scale value of the Western Ontario and McMaster Osteoarthritis Index(WOMAC) score |  | 4 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the WOMAC subscales (pain, stiffness, and function) |  | at baseline(0 week), 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation | 
| Mean change in Visual Analogue Scale for the pain intensity |  | Assessing participants at baseline(0 week), 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation | 
| Change of Patient global assessment score |  | at 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moxa smoke, Moxibustion, Knee osteoarthritis