The effect of infrared heating or traditional moxibustion in osteoarthritis of the knee

ISRCTN ISRCTN14604492
DOI https://doi.org/10.1186/ISRCTN14604492
EudraCT/CTIS number Nil known
ClinicalTrials.gov number Nil known
Secondary identifying numbers Nil known
Submission date
25/12/2020
Registration date
05/01/2021
Last edited
16/07/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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. Based on previous research, traditional moxibustion and laser moxibustion could relieve pain effectively and improve function in patients.
Moxibustion is a type of traditional Chinese medicine. It involves burning moxa, a cone or stick made of ground mugwort leaves, on or near your body's meridians and acupuncture points.
The aim of this study is to compare the effects of laser moxibustion and traditional moxibustion on knee pain in osteoarthritis.

Who can participate?
Patients aged 50 to 75 undergoing conventional knee osteoarthritis treatment

What does the study involve?
Participants are randomly allocated to be treated with either CO2 laser moxibustion or traditional moxibustion at the acupoints on the affected knee(s). Patients in both groups receive 20 minutes of treatment, three times per week for 4 weeks. The effects of treatment are assessed through questionnaires at the start of the study and at 2, 4, 8, 12 and 24 weeks after they join the study. The assessments will take place at either Tongren Hospital or Shanghai Pudong Hospital except for the assessment at 24 weeks, where the questionnaire will be mailed to participants.

What are the possible benefits and risks of participating?
CO2 laser moxibustion and traditional moxibustion can reduce pain and improve knee joint stiffness and function in patients with knee osteoarthritis. Some patients might have local skin flushing or blistering (not instantly, but usually one day after treatment) at the site of treatment. Usually, the blister is naturally absorbed within a day or two without obvious scarring of the skin.

Where is the study run from?
1. Tongren Hospital Affiliated to Shanghai Jiaotong University (China)
2. Shanghai Pudong Hospital of Traditional Chinese Medicine (China)

When is the study starting and how long is it expected to run for?
June 2019 to May 2021

Who is funding the study?
Shanghai Key Laboratory of acupuncture mechanism and acupoint function (China)

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

Contact information

Miss Jing Fang
Public

Shanghai Key Laboratory of Acupuncture Mechanism and Acupoint Function
Shanghai University of Traditional Chinese Medicine
1200 Cailun Road
shanghai
201203
China

Phone +86 18816511872
Email sxy1@shutcm.edu.cn

Study information

Study designInterventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleThe efficacy of moxibustion and infrared laser moxibustion in knee osteoarthritis: A randomized non-inferiority study
Study acronymEILMK
Study objectivesA 4-week CO2 infrared laser moxibustion will reduce pain and improve knee joint stiffness and function among patients with knee osteoarthritis as compared with traditional moxibustion treatment
Ethics approval(s)Approved 10/07/2019, Institutional Review Board (IRB) of Tongren Hospital Affiliated to Shanghai Jiaotong University (Room 309, Building 6-3, 1111 Xianxia Road, Changning District, Shanghai, China, 201103; +86 (021) 52039999-96341; no email provided), ref: 2019-022-02
Health condition(s) or problem(s) studiedKnee osteoarthritis
InterventionPatients with knee osteoarthritis are randomly allocated into either CO2 laser moxibustion or traditional moxibustion groups.

Patients will receive CO2 laser moxibustion or traditional moxibustion treatment on ST35, EX-LE4 and Ashi points in the area of the affected knee(s). Patients in both groups receive 20 minutes of treatment, 3 times per week for 4 weeks.

The effects of treatment on the most painful joint (which is identified through participant report at baseline and is the joint assessed throughout the study) are assessed at the hospital at baseline, 2 (mid-term), 4 (the end of treatment), 8, and 12 weeks after baseline. During the follow-up period (5 to 24 weeks), the subject report on adverse events and side effects will be sought via telephone call weekly.

Participants will be allowed to take any analgesic or non-steroidal anti-inflammatory drugs that they used before the study. They will be asked to record the daily dose during the entire clinical trial, and then the investigators will analyze the changes in the dose.

Laser moxibustion: The wavelength of laser irradiation was 10.6 μm, and the output power was adjusted in the range of 160-180 mW. Energy density ranged from 61.2 to 68.8 J/cm2 for one treatment.

Traditional moxibustion:We used a commercially available moxibustion device (Nanyang Hanyi Moxa Company, Ltd., Nanyang, Henan, China). It has a cylindrical opening to hold a pillar of moxa; at its base is an adhesive membrane. During treatment, the device is placed at an acupoint, and the moxa is burned about 8 mm above the skin.

Both groups have 20 minutes of treatment.
Intervention typeOther
Primary outcome measureKnee pain, measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at baseline and 2, 4, 8, 12, and 24 weeks
Secondary outcome measures1. Knee function measured using the WOMAC function score at baseline, weeks 2, 4, 8, 12, and 24 weeks
2. Knee stiffness measured using the WOMAC stiffness score at baseline, weeks 2, 4, 8, 12, and 24 weeks
3.Knee osteoarthritis symptoms measured using the WOMAC total score at baseline, weeks 2, 4, 8, 12, and 24 weeks
4. Knee pain measured using the Visual Analogue Scale (VAS) pain score at baseline, weeks 2,4, 8, 12, and 24 weeks
5. The 50-yard walking time was assessed and recorded among the participants at baseline, weeks 4 and 12weeks to observe improvements in walking.
6. Quality of life measured using the 36-Item Short Form Health Survey (SF-36) at 4, 12 and 24 weeks and the Quality of Life Scale (QOLS) at 4 weeks
7. Participant perception of the safety of the treatment measured by investigator question (with possible answers of: safe, less safe, safety problem, or serious safety problem) at 4 weeks
Overall study start date01/06/2019
Completion date01/05/2021

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants92
Total final enrolment92
Key inclusion criteriaPatients aged 50 to 75 undergoing conventional knee osteoarthritis treatment
Key exclusion criteria1. Knee pain caused by other diseases (such as rheumatoid arthritis, fibromyalgia syndrome, chronic fatigue syndrome, and ankylosing spondylitis)
2. Treatment with steroid drugs in the past 3 months
3. Received acupuncture or moxibustion treatment in the past 3 months
4. Intra-articular injection of hyaluronate in the past 6 months
5. Joint puncture or arthroscopy in the past year
6. Previous (or planned for during the trial) knee or hip replacement surgery
7. Use of other topical treatments for osteoarthritis of the knee
8. Diagnosis of any serious diseases including, but not limited to, heart disease, lung disease, kidney disease, liver disease, malignant tumor, systemic infection, infectious disease, and/or mental illness
9. Participation in another clinical study in the past month
Date of first enrolment15/07/2019
Date of final enrolment01/01/2021

Locations

Countries of recruitment

  • China

Study participating centres

Tongren Hospital Affiliated to Shanghai Jiaotong University
No.1111 Xianxia Road Changning District
Shanghai
200336
China
Shanghai Pudong Hospital of Traditional Chinese Medicine
No. 399 Pingchuan Road Pudong New District
Shanghai
201200
China

Sponsor information

Shanghai University of Traditional Chinese Medicine
University/education

1200 Cailun Road
Pudong new district
Shanghai
201203
China

Phone +86 (0)21 51322042
Email kyctcm@vip.sina.com
Website http://www.shutcm.edu.cn/web/guest/index
ROR logo "ROR" https://ror.org/00z27jk27

Funders

Funder type

University/education

Shanghai University of Traditional Chinese Medicine
Government organisation / Local government
Alternative name(s)
Shanghai University of TCM, SHUTCM
Location
China

Results and Publications

Intention to publish date01/05/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planA study is planned for publication in a medical journal.
IPD sharing planAll data generated or analysed during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 15/07/2021 16/07/2021 Yes No

Editorial Notes

16/07/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
04/01/2021: Trial’s existence confirmed by Tongren Hospital Affiliated to Shanghai Jiaotong University.