Moxibustion in Osteoarthritis of the Knee

February 13, 2020 updated by: Chengdu University of Traditional Chinese Medicine

The Effectiveness of Moxibustion Treatment for Osteoarthritis of the Knee : a Double-blinded, Double-dummy, Randomized Controlled Trial

This is a multicenter , double-blinded, double-dummy, randomized controlled clinical trial to evaluate the efficacy of moxibustion for osteoarthritis of the knee.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

144

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610075

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 )

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change of the global scale of the Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Time Frame: 4 weeks from baseline
4 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at baseline(0 week), 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation
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
at baseline(0 week), 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation
The change of Patient global assessment score
Time Frame: 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation
2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015CB55450401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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