Moxibustion in Osteoarthritis of the Knee

• ClinicalTrials.gov Identifier: NCT02769572
• Recruitment Status: Completed
• First Posted: May 11, 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 multicenter , double-blinded, double-dummy, randomized controlled clinical trial to evaluate the efficacy of moxibustion for osteoarthritis of the knee.

Condition or disease	Intervention/treatment	Phase
Knee Osteoarthritis	Other: real moxibustion; Drug: placebo gel; Drug: diclofenac sodium gel; Other: sham moxibustion	Phase 3

Detailed Description:

Aim: To evaluate the effectiveness of moxibustion treatment for patients with osteoarthritis of the knee, with respect to relieving pain, improving the dysfunction and improving their quality of life as well.

Design: A multicentre, double-blinded, double-dummy, randomized controlled clinical study will be performed in China. Eligible participants will be randomly assigned to moxibustion group (real moxibustion plus placebo gel) and the control group (diclofenac sodium gel plus sham moxibustion) with a 1:1 allocation ratio. Participants in both groups will receive 12 sessions of real/sham moxibustion in 4 weeks at 3 acupoints (ST35, EX-LE4, ST36 ). Either diclofenac sodium gel or placebo gel will be applied 4 g per knee 4 times daily for 4 weeks. 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 primary outcome measure will be the change of the global scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the end of the course. The secondary outcomes include the change of other subscales (pain, stiffness, and function) of WOMAC, Visual Analogue scale (VAS) and Patient Global Assessment (PGA). Safety will be assessed at every visit.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effectiveness of Moxibustion Treatment for Osteoarthritis of the Knee : a Double-blinded, Double-dummy, Randomized Controlled Trial
• Actual Study Start Date: May 2016
• Actual Primary Completion Date: June 2019
• Actual Study Completion Date: June 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: real moxibustion plus placebo gel; In subjects with osteoarthritis of the knee	Other: real moxibustion; 3 times a week for 4 consecutive weeks,totally 12 sessions at 3 acupoints (ST35, EX-LE4, ST36 ); Drug: placebo gel; 4 grams per knee, 4 times per day, for 4 weeks
Active Comparator: diclofenac sodium gel plus sham moxibustion; In subjects with osteoarthritis of the knee	Drug: diclofenac sodium gel; 4 grams per knee, 4 times per day, for 4 weeks; Other: sham moxibustion; 3 times a week for 4 consecutive weeks,totally 12 sessions at 3 acupoints (ST35, EX-LE4, ST36 )

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. The changes from baseline to 2, 4, 8,12 weeks 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. The change from baseline to 2, 4, 8,12 weeks in Visual Analogue Scale for the pain intensity. [ Time Frame: at baseline(0 week), 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation ]
3. The change of Patient global assessment score [ Time Frame: 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:

• Male or female, aged between 40 and 75 years, with knee osteoarthritis diagnosed according to American College of Rheumatology criteria
• Radiologic confirmation of osteoarthritis in 1 or both knees (Kellgren-Lawrence score 2 or 3)
• Had knee pain in one or both knee(s) of longer than 3 months'duration
• The average severity of knee pain at least 3 points on a10-point of visual analogue scale(VAS)
• Never experienced moxibustion before this trial
• Participants who are willing to comply with our study protocol
• Participants who agree to sign the consent form

Exclusion Criteria:

• Subjects with serious diseases including cancer, uncontrolled hypertension, diabetes mellitus requiring insulin injection, life-threatening cardiovascular or neurological events, chronic respiratory disease, a haemorrhagic disorder and serious mental diseases
• Subjects had pain in the knee may caused by inflammatory, malignant, autoimmune disease or traumatic injury;
• Subjects received knee replacement surgery for the affected knee
• Subjects received knee arthroscopy within the past year, steroid or hyaluronic acid injection in the knee joints within the previous 3 months
• Subject who currently participate in another clinical trial
• Subjects received physiotherapy or other treatments for osteoarthritis knee pain (with the exception of non-steroidal anti-inflammatory drugs) during the previous 4 weeks;

Contacts and Locations

Locations

China, Sichuan

Chengdu, Sichuan, China, 610075

Sponsors and Collaborators

Chengdu University of Traditional Chinese Medicine

Investigators

• Study Director: Yong Tang, Professor; Chengdu University of Chinese Traditional Medicine
• Principal Investigator: Jianying Zhou; Chengdu University of Chinese Traditional Medicine

More Information

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

Zhou JY, Luo L, Zhu LL, Yin HY, Wu Q, Peng JX, Zhang CS, Lv P, Tang Y, Yu SG. Moxibustion versus diclofenac sodium gel for the treatment of knee osteoarthritis: a study protocol for a double-blinded, double-placebo, randomised controlled trial. BMJ Open. 2017 Apr 12;7(4):e012879. doi: 10.1136/bmjopen-2016-012879.

• Responsible Party: Chengdu University of Traditional Chinese Medicine
• ClinicalTrials.gov Identifier: NCT02769572
• Other Study ID Numbers: 2015CB55450401
• First Posted: May 11, 2016
• Last Update Posted: February 17, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by Chengdu University of Traditional Chinese Medicine:

Knee osteoarthritis; moxibustion; diclofenac sodium gel

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Diclofenac; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action