- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02772055
Efficacy of Moxibustion Therapy With or Without Smoke for Knee Osteoarthritis
A Multicentre, Randomised, Single Blinded, Parallel-group Study of Moxa Smoke Effect in Moxibustion Treating Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610075
- Chengdu University of Traditional Chinese Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: moxibustion group
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.
|
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.
|
Experimental: smoke-free moxibustion group
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the global scale value of the Western Ontario and McMaster Osteoarthritis Index(WOMAC) score
Time Frame: 4 weeks from baseline
|
4 weeks from baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the WOMAC subscales (pain, stiffness, and function)
Time Frame: at baseline(0 week), 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation
|
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
Time Frame: Assessing participants at baseline(0 week), 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation
|
Assessing participants at baseline(0 week), 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation
|
Change of Patient global assessment score
Time Frame: at 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation
|
at 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yu Shuguang, Professor, Chengdu University of Traditional Chinese Medicine
Publications and helpful links
General Publications
- Luo L, Liao M, Peng JX, Ma Q, Zhou JY, Zhu LL, Wang X, Chen SS, Yin HY, Wu QF, Zhang CS, Lv P, Tang Y, Yu SG. Comparison of the Efficacy between Conventional Moxibustion and Smoke-Free Moxibustion on Knee Osteoarthritis: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2019 Mar 14;2019:1291947. doi: 10.1155/2019/1291947. eCollection 2019.
- Zhu LL, Zhou JY, Luo L, Wang X, Peng JX, Chen SS, Yin HY, Wu QF, Zhang CS, Lv P, Tang Y, Yu SG. Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial. Trials. 2017 Apr 24;18(1):188. doi: 10.1186/s13063-017-1846-2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015CB554504-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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