Efficacy of Moxibustion Therapy With or Without Smoke for Knee Osteoarthritis

• ClinicalTrials.gov Identifier: NCT02772055
• Recruitment Status: Completed
• First Posted: May 13, 2016
• Last Update Posted: February 17, 2020
• Sponsor: Chengdu University of Traditional Chinese Medicine
• Information provided by (Responsible Party): Chengdu University of Traditional Chinese Medicine

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Pain	Other: Moxibustion; Other: Moxa smoke purification device	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Multicentre, Randomised, Single Blinded, Parallel-group Study of Moxa Smoke Effect in Moxibustion Treating Knee Osteoarthritis
• Actual Study Start Date: May 2016
• Actual Primary Completion Date: May 2019
• Actual Study Completion Date: December 2019

Arms and Interventions

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.	Other: Moxibustion; 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.	Other: Moxibustion; 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.; Other: Moxa smoke purification device; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in the global scale value of the Western Ontario and McMaster Osteoarthritis Index(WOMAC) score [ Time Frame: 4 weeks from baseline ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. Change of Patient global assessment score [ Time Frame: at 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation ]

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Participants meeting the following criteria will be included:

1. aged between 40 and 75 years
2. diagnosed with knee osteoarthritis formulated by the American College of Rheumatology (ACR).
3. the average severity of knee pain not more than 7 points on a visual analogue scale for most days during the past month
4. agree not have the paregoric during the whole treatment phase
5. 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:

1. inflammatory diseases, including rheumatoid arthritis, cancer, traumatic injury that might be related to the current knee pai
2. autoimmune disease, uncontrolled hypertension
3. diabetes mellitus requiring insulin injection
4. life-threatening cardiovascular or neurological events within the past year
5. chronic respiratory disease,a haemorrhagic disorder
6. alcohol or drug addiction
7. an active infectious disease including tuberculosis
8. a significant knee joint deformity
9. knee replacement surgery for the affected knee
10. knee arthroscopy within the past year
11. steroid injection in the knee joints within the past 3 months
12. injections in the knee joints or joint fluid injection within the past 6 months
13. accept acupuncture, moxibustion, cupping, or herbal medicine within the past 4 weeks

Contacts and Locations

Locations

China, Sichuan

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China, 610075

Sponsors and Collaborators

Chengdu University of Traditional Chinese Medicine

Investigators

• Principal Investigator: Yu Shuguang, Professor; Chengdu University of Traditional Chinese Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Chengdu University of Traditional Chinese Medicine
• ClinicalTrials.gov Identifier: NCT02772055
• Other Study ID Numbers: 2015CB554504-02
• First Posted: May 13, 2016
• Last Update Posted: February 17, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Chengdu University of Traditional Chinese Medicine:

Moxa smoke; Moxibustion; Knee osteoarthritis

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases