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Moxibustion in Osteoarthritis of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02769572
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 )




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 ]


Information from the National Library of Medicine

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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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769572


Locations
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China, Sichuan
Chengdu, Sichuan, China, 610075
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Investigators
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Study Director: Yong Tang, Professor Chengdu University of Chinese Traditional Medicine
Principal Investigator: Jianying Zhou Chengdu University of Chinese Traditional Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02769572    
Other Study ID Numbers: 2015CB55450401
First Posted: May 11, 2016    Key Record Dates
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:
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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