Condition category
Musculoskeletal Diseases
Date applied
03/04/2014
Date assigned
24/04/2014
Last edited
18/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Osteoarthritis, a common joint disorder, is the most common form of arthritis in the world. The knee joint is the most common site affected by osteoarthritis. Joint pain caused by knee osteoarthritis can severely reduce the patient’s quality of life. The purpose of this study is to observe whether the traditional Chinese medicinal therapy moxibustion provides greater relief from pain and joint stiffness and improved function.

Who can participate?
Patients aged 45 years or older, male or female, undergoing conventional knee osteoarthritis treatment.

What does the study involve?
Patients were randomly allocated to receive either real or sham moxibustion. Patients in both groups received 20 minutes of treatment, three times per week for 6 weeks. The effects of treatment were assessed at the start of the study and after 3 weeks, 6 weeks (the end of treatment), 12 weeks and 24 weeks.

What are the possible benefits and risks of participating?
Moxibustion can reduce pain and improve knee joint stiffness and function in patients with knee osteoarthritis. Some patients have had local skin flushing or blistering (not instantly, but usually 1 day after treatment) at the site of treatment. Usually the blister was naturally absorbed within 3 days without obvious scarring on the skin.

Where is the study run from?
Traditional Chinese Medicine Hospital of Pudong New District, Shanghai, China; the Community Service Center of Chuansha, Pudong, Shanghai, China; and the Nantong University's affiliated hospital, Nantong, China.

When is the study starting and how long is it expected to run for?
The study started in August 2009 and recruitment ended in November 2011.

Who is funding the study?
National Basic Research Program of China, National Natural Science Foundation of China, The Key Program of State Administration of Traditional Chinese Medicine of China, and the Shanghai Municipal Science Foundation.

Who is the main contact?
Prof. Xueyong Shen
sxy1@shutcm.edu.cn

Trial website

Contact information

Type

Scientific

Primary contact

Prof Xueyong Shen

ORCID ID

Contact details

1200 Cailun Road
Pudong District
Shanghai
201023
China
-
sxy1@shutcm.edu.cn

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ChiCTR-TRC-11001408

Study information

Scientific title

Effectiveness of moxibustion treatment as adjunctive therapy in osteoarthritis of the knee: a randomized, double-blinded, placebo-controlled clinical trial

Acronym

Study hypothesis

The hypothesis is that the moxibustion can reduce pain and improve knee joint stiffness, function, and quality of life in patients with knee osteoarthritis.

Ethics approval

Institutional Ethic Review Committee of Chinese Clinical Trials Registry, 28/06/2011, ChiECRCT-20110022

Study design

Multi-centre double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Knee osteoarthritis

Intervention

Patients with knee osteoarthritis were randomly divided into real and sham moxibustion groups. Patients received moxibustion and sham moxibustion treatment on Dubi (ST-35), EX-LE4, and an Ashi point in the area of the affected knee(s). Three consecutive moxa pillars were burned at each point. Once the device was affixed at a point, the first pillar was lit. After burning, the residual pillar was removed and another pillar was inserted and
burned. A pillar burns for about 6 min, making the moxibustion session about 20 min long. Patients in both groups received 20 minutes of treatment, three times per week for 6 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

WOMAC (VAS3.1) Questionnaire was applied to assess the therapeutic effects in terms of joint pain, stiffness, and functional disorder of the participants at 3 weeks and 6 weeks after the treatment initiation, and the long-term effects were also assessed at 12, and 24 weeks after baseline

Secondary outcome measures

1. Short Form 36 (SF-36) component scales were used to assess health-related quality of life at baseline, week 3, week 6 and week 12
2. The 50-yard walking time was assessed and recorded at baseline and week 6 to observe the improvement in walking

Overall trial start date

01/08/2009

Overall trial end date

30/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female, 45 or older, with knee osteoarthritis diagnosed according to American College of Rheumatology criteria, including radiographic evidence of at least one osteophyte at the tibiofemoral joint in one or both knees (Kellgren–Lawrence score 2 or 3)
2. Pain score of at least 3 points on a 10-point visual analogue scale for most days during the previous month
3. Willingness to sign the consent form and be randomly assigned into either a treatment or a placebo group

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

110

Participant exclusion criteria

1. Presence of serious medical conditions that preclude participation in the study
2. Intra-articular corticosteroid or hyaluronate injections, knee surgery, or use of topical capsaicin cream during the preceding 6 months
3. Previous experience with moxibustion
4. Planned events such as knee replacement that would interfere with participation in all 24 weeks of the study

Recruitment start date

01/08/2009

Recruitment end date

01/11/2011

Locations

Countries of recruitment

China

Trial participating centre

1200 Cailun Road
Shanghai
201023
China

Sponsor information

Organisation

Shanghai University of Traditional Chinese Medicine (China)

Sponsor details

1200 Cailun Road
Pudong District
Shanghai
201203
China
-
sxy1@shutcm.edu.cn

Sponsor type

University/education

Website

http://www.csc.edu.cn/laihua/universitydetailen.aspx?collegeId=194

Funders

Funder type

Government

Funder name

National Basic Research Program of China (2009CB522901)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Natural Science Foundation of China (81320108028, 81202648)

Alternative name(s)

National Science Foundation of China, Natural Science Foundation of China, NSFC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

China

Funder name

The Key Program of State Administration of Traditional Chinese Medicine of China (ZYSNXD-CC-ZDXK-07)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Shanghai Municipal Science Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24962039
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25688277

Publication citations

  1. Results

    Zhao L, Cheng K, Wang L, Wu F, Deng H, Tan M, Lao L, Shen X, Effectiveness of moxibustion treatment as adjunctive therapy in osteoarthritis of the knee: a randomized, double-blinded, placebo-controlled clinical trial., Arthritis Res. Ther., 2014, 16, 3, R133, doi: 10.1186/ar4590.

  2. Results

    Ren X, Yao C, Wu F, Li Z, Xing J, Zhang H, Effectiveness of moxibustion treatment in quality of life in patients with knee osteoarthritis: a randomized, double-blinded, placebo-controlled trial, Evid Based Complement Alternat Med, 2015, 2015, 569523, doi: 10.1155/2015/569523.

Additional files

Editorial Notes