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 patients 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
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 (KellgrenLawrence 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
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