The efficacy of jade moxibustion in knee osteoarthritis

ISRCTN	ISRCTN21174552
DOI	https://doi.org/10.1186/ISRCTN21174552

Submission date: 21/02/2020
Registration date: 28/02/2020
Last edited: 05/06/2024

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. The aim of this study is to compare the effects of jade 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 jade 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?
Jade 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?
May 2019 to June 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

Mr Xueyong Shen
Scientific

Shanghai University of Traditional Chinese Medicine
1200 Cailun Road
Pudong New District
Shanghai
201203
China

Phone	+86 2151322175
Email	sxy1@shutcm.edu.cn

Mr Lusheng Chen
Public

Shanghai University of Traditional Chinese Medicine
1200 Cailun Road
Pudong District
Shanghai
201203
China

ORCID ID	0000-0001-9618-3080
Phone	+86 13681913509
Email	13681913509@163.com

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	Comparison of the efficacy of jade moxibustion and traditional moxibustion in knee osteoarthritis: a pilot randomized clinical trial
Study objectives	A 4-week jade moxibustion treatment regimen will reduce pain among patients with knee osteoarthritis as compared with traditional moxibustion treatment, and the therapeutic effect might be related to the cytokines such as Interleukin in serum.
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), ref: 2019-022-02
Health condition(s) or problem(s) studied	Knee osteoarthritis
Intervention	Patients with knee osteoarthritis are randomly allocated into either jade moxibustion or traditional moxibustion groups. Patients will receive jade moxibustion or traditional moxibustion treatment on ST35, ST34, EX-LE4, SP10 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. At 24 weeks, the questionnaire will be mailed to the subjects and they will be asked to post them back after filling them out. 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.
Intervention type	Other
Primary outcome measure	Knee 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 measures	1. 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. Sensation measured by investigator question "What do you feel during the treatment?" (with possible answers of: heat, cold, pain, no feeling, or other which will be described) 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 8. Dose of analgesic or non-steroidal anti-inflammatory drugs consumed, determined through daily participant reports from baseline to 24 weeks 9. Any adverse events or side effects during the study are determined from the subject and investigator reports collected weekly from baseline to 24 weeks. Common side effects include redness and blisters by jade moxibustion and traditional moxibustion. Serious adverse events will also be reported to the Ethics Committee
Overall study start date	01/05/2019
Completion date	30/06/2021

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	148
Total final enrolment	94
Key inclusion criteria	1. Aged 50 to 75 years 2. Knee osteoarthritis according to the American College of Rheumatology Diagnostic Criteria 3. Radiologic confirmation of knee osteoarthritis (Kallgren-Lawrence level ≥1) 4. Moderate to severe knee pain on most days of the past month (VAS score for arthritic pain ≥40) 5. Has a full understanding and gives informed consent to participate in the study
Key exclusion criteria	1. 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 enrolment	10/07/2019
Date of final enrolment	31/12/2020

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"	https://ror.org/00z27jk27

Funders

Funder type

Industry

Shanghai Key Laboratory of Acupuncture Mechanism and Acupoint Function
Private sector organisation / Research institutes and centers

Alternative name(s): SKLAA
Location: China

Results and Publications

Intention to publish date	30/04/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a peer reviewed medical journal and planned presentations at local and international conferences.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Xueyong Shen (sxy1@shutcm.edu.cn) or Dr Lusheng Chen (13681913509@163.com).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/04/2020	27/04/2020	Yes	No
Results article		04/06/2023	05/06/2024	Yes	No

Editorial Notes

05/06/2024: Publication reference and total final enrolment added.
27/04/2020: Publication reference added.
04/03/2020: Internal review.
27/02/2020: Trial’s existence confirmed by the Institutional Review Board (IRB) of Shanghai Tongren Hospital.