Condition category
Musculoskeletal Diseases
Date applied
22/08/2013
Date assigned
06/09/2013
Last edited
06/09/2013
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 in the oriental population. Joint pain caused by knee osteoarthritis can severely impair the patient’s quality of life. The purpose of this study is to observe whether a Chinese medicinal therapy, infrared laser moxibustion, provides greater relief from pain and joint stiffness and improved function.

Who can participate?
Patients aged 50 years or older, male or female, undergoing knee osteoarthritis treatment can participate in the study.

What does the study involve?
Patients with knee osteoarthritis were randomly divided into real and sham laser moxibustion groups. Patients received 10.6 μm infrared laser moxibustion and sham laser moxibustion treatment. Patients in both groups received 20 minutes of treatment, three times per week for 4 weeks. The effects of treatment were assessed before, mid-term (after 2 weeks), at the end (after 4 weeks) and 4 weeks post-treatment termination. Time taken to walk 50 yards was also calculated.

What are the possible benefits and risks of participating?
Infrared laser 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 one day after treatment) at the site of irradiation. Usually the blister was naturally absorbed within a day or two without obvious scarring of the skin.

Where is the study run from?
Longbai Community Health Service Center in Shanghai Minhang District, China.

When is the study starting and how long is it expected to run for?
The study started in August 2010 and recruitment ended in July 2011.

Who is funding the study?
The study was supported by:
1. National Basic Research Program of China
2. National Natural Science Foundation of China
3. The Key Program of State Administration of Traditional Chinese Medicine of China
4. 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

9408
1200 Cailun Rd.
Shanghai
201203
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ChiCTR-TRC-12002338

Study information

Scientific title

Effects of CO2 infrared laser moxibustion on patients with knee osteoarthritis: a double-blind, randomized, controlled study

Acronym

Study hypothesis

The hypothesis is that the CO2 infrared laser moxibustion can reduce pain and improve knee joint stiffness and function in patients with knee osteoarthritis.

Ethics approval

Institutional Review Board of Shuguang Hospital Affiliated Shanghai University of Traditional Chinese Medicine.
The study was approved on 14 June 2007.

Study design

Single-centred 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

Patients with knee osteoarthritis

Intervention

Patients with knee osteoarthritis were randomly divided into real and sham laser moxibustion groups. Patients received 10.6 μm infrared laser moxibustion and sham laser moxibustion treatment on Dubi (ST-35) leg acupoint symmetrically. Patients in both groups received 20 minutes of treatment, three times per week for 4 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 after 2 weeks and 4 weeks of the treatment initiation, and the long-term effects were also assessed 4 weeks post-treatment.

Secondary outcome measures

The 50-yard walking time was assessed and recorded among the participants after 2 weeks and 4 weeks of the treatment as well as 4 weeks post-treatment to observe improvements in walking. In the follow-up, we asked the participants to assess their therapeutic effects and guess their group assignment to assess the masking effectiveness of the trial. Additionally, the participants would also be asked whether they thought the treatment were safe.

Overall trial start date

01/08/2010

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Middle-aged and aged individuals, aged 50 years or older, male or female
2. According to the knee OA diagnostic criteria of the American College of Rheumatology, radiographic evidence of at least 1 osteophyte at the tibiofemoral joint (Kellgren–Lawrence grade II or III)
3. Moderate or greater clinically significant knee pain on most days during the past month
4. No acupuncture or moxibustion treatment received in the previous 3 months
5. Willingness to be randomly assigned; understanding and signing the informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

190

Participant exclusion criteria

1. Diagnosis with inflammatory arthritis, gout, acute knee joint injury or other knee arthritis (without cartilage involvement), meniscus injury, ligament injury and intra-articular fracture
2. Presence of serious heart diseases, kidney diseases, liver diseases or malignant tumors (unless the patient was surgically treated and with no relapse more than 5 years), systemic infection or contagious diseases
3. Intra-articular corticosteroid or hyaluronate injections (as well as any knee surgery or topical use of medication) during the past 6 months, or previous history of knee surgery
4 Previous experience with drug tests

Recruitment start date

01/08/2010

Recruitment end date

31/07/2011

Locations

Countries of recruitment

China

Trial participating centre

9408, 1200 Cailun Rd.
Shanghai
201203
China

Sponsor information

Organisation

Shanghai University of Traditional Chinese Medicine (China)

Sponsor details

c/o Huangan Wu
650
South Wanping Rd.
Shanghai
200030
China

Sponsor type

University/education

Website

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 (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 and the Shanghai Municipal Science Foundation (11DZ1973300)

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

Publication citations

Additional files

Editorial Notes