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 aim of this study is to observe the effect and safety of CO2 laser irradiation on acupuncture points (laser moxibustion) in patients with knee 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 real (verum) or sham laser 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 at the start of the study, week 2 (mid-term), week 4 (the end of treatment), week 8, 12 and 24.
What are the possible benefits and risks of participating?
Laser 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. Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine (China)
2. Renji Hospital affiliated to Shanghai Jiaotong University (south part) (China)
3. Shanghai East Hospital affiliated to Tongji University (China)
4. Shanghai Tongren Hospital affiliated to Shanghai Jiaotong University (China)
5. Shanghai Hudong Hospital (China)
When is the study starting and how long is it expected to run for?
January 2014 to December 2018
Who is funding the study?
1. National Basic Research Program of China
2. National Natural Science Foundation of China
3. Shanghai development office of Traditional Chinese Medicine
Who is the main contact?
Prof. Xueyong Shen
sxy1@shutcm.edu.cn
Trial website
Contact information
Type
Scientific
Primary contact
Mr Xueyong Shen
ORCID ID
Contact details
Shanghai University of Traditional Chinese Medicine (China)
1200 Cailun Road
Pudong new district
Shanghai
201203
China
+86 (0)21 51322175
sxy1@shutcm.edu.cn
Type
Public
Additional contact
Dr Ke Cheng
ORCID ID
Contact details
1200 Cailun Road
Pudong district
Shanghai
201203
China
+86 (0)21 51322605
cheng_ker@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effectiveness of CO2 laser moxibustion treatment for knee osteoarthritis: a double-blind randomized controlled trial
Acronym
Study hypothesis
A 4-week CO2 laser moxibustion treatment regimen reduces pain among patients with knee OA as compared with sham laser moxibustion treatment, and the therapeutic effect might be related to the cytokines such as Interleukin in serum.
Ethics approval
Current ethics approval as of 28/08/2018:
1. Institutional Review Board (IRB) of Shuguang hospital affiliated to Shanghai University of traditional Chinese medicine, No. 2014-341-37-01 (2014/08/13), No. 2014-341-37-02 (2015/08/13), No. 2014-341-37-03 (2016/08/31).
2. IRB of Shanghai East Hospital affiliated to Tongji University, 2014/10, No. 2013-24
3. IRB of Renji Hospital affiliated to Shanghai Jiaotong University, 2015/02/25, No. 2015-001
4. IRB of Shanghai Changning Tianshan Traditional Chinese Medicine Hospital, 2017/07/14, No. 2017TSKY04
5. IRB of Shanghai Tongren Hospital affiliated to Shanghai Jiaotong University, 2018/06/01, No. 2018-006-02
Previous ethics approval as of 24/08/2018:
1. Institutional Review Board (IRB) of Shuguang hospital affiliated to Shanghai University of
traditional Chinese medicine, 13/08/2014, No. 2014-341-37-01
2. IRB of Shanghai East Hospital affiliated to Tongji University, 2014/10, No. 2013-24
3. IRB of Renji Hospital affiliated to Shanghai Jiaotong University, 2015/02/25, No. 2015-001
4. IRB of Shanghai Changning Tianshan Traditional Chinese Medicine Hospital, 2017/07/14, No. 2017TSKY04
5. IRB of Shanghai Tongren Hospital affiliated to Shanghai Jiaotong University, 2018/06/01, No. 2018-006-02
Previous ethics approval:
1. Institutional Review Board (IRB) of Shuguang hospital affiliated to Shanghai University of traditional Chinese medicine, 13/08/2014, ref: 2014-341-37-01
2. IRB of Shanghai East Hospital affiliated to Tongji University, October 2014, ref: 2013-24
3. IRB of Renji Hospital affiliated to Shanghai Jiaotong University, 25/02/2014, ref: 2015-001
4. IRB of Shanghai Tongren Hospital affiliated to Shanghai Jiaotong University, 14/03/2017, ref: 2017-32
Study design
Randomized multi-center double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Knee osteoarthritis
Intervention
Patients with knee osteoarthritis are randomly allocated into either verum or sham CO2 laser moxibustion groups. Patients receive verum or sham laser moxibustion treatment on Dubi (ST-35) and an Ashi (tender) point 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 are assessed at baseline, week 2 (mid-term), week 4 (the end of treatment), week 8, 12 and 24 after baseline.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Knee pain, measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores from baseline to 4 weeks. The most painful joint reported by participants at baseline is assessed during the whole study. Change of WOMAC pain is also assessed at week 2, 8, 12, and 24.
Secondary outcome measures
1. Knee function, measured using the WOMAC function scores at week 4. It is also assessed at week 2, 8, 12, and 24
2. Knee stiffness, measured using the WOMAC stiffness score, and WOMAC overall score at baseline, week 2, 4, 8, 12 and 24
3. Pain, measured using the visual analog scale (VAS) at baseline, week 2, 4, 8, 12 and 24
4. Health-related quality of life, measured using the Short Form 36 (SF-36) component scales at baseline, week 4, 12 and 24
5. Walking ability, measured using the 50-feet (i.e., 15.24 meters) walking time at baseline, week 4 and 12
6. Patients’ global assessment of OA, evaluated on a five point Likert scale at week 4
7. Guess of the group assignment to assess the masking effectiveness of the trial:
7.1. Guess from the treatment providers at week 4
7.2. Guess from the participants of their allocation at week 1 after the first treatment and at week 4
8. Assessment of safety: any adverse event, whether related to treatment or not, reported by the participants and practitioners at every visit. During the 20-week follow-up period (from week 5 to week 24), each participant is telephoned every week to follow any adverse event or side effect that occurs. Serious adverse effects are reported to DSMB and Medical Ethics Committee. The participants are asked to assess the safety of the treatment after 4 weeks’ treatment, in terms of four grades: safe, relatively safe, unsafe, and very unsafe
9. Participants' sensations, asked during the treatment at every visit
10. Usage of medication, measured using a Medication Usage Log to record their daily intake of pain medications prescribed on a symptom-contingent (i.e., as per necessary, prn) basis
Exploratory outcome:
Serum levels of IL-1β, COX-2, COMP, TNF-α, IL-6, IL-17, IL-8, IL-4, IL-10 and IL-13 (considered as important cytokines involved in the progress of OA), measured using blood tests at baseline and week 4
Overall trial start date
01/01/2014
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosed with idiopathic knee OA according to the American Rheumatism Association (ARA) classification criteria as follows: knee pain with three of the following or knee joint osteophyte with one of the following conditions:
1.1. Age over 50 years
1.2. Morning stiffness within 30 minutes of waking
1.3. Crepitus
1.4. Bony tenderness
1.5. Bony enlargement
1.6. No palpable warmth
2. Kellgren-Lawrence grade ≥ 1 (Kellgren Lawrence Grading Scale: Grade 1: doubtful narrowing of joint space and possible osteophytic lipping; Grade 2: definite osteophytes, definite narrowing of joint space, Grade 3: moderate multiple osteophytes, definite narrowing of joints space, some sclerosis and possible deformity of bone contour; Grade 4: large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone contour)
3. Moderate or greater clinically significant knee pain on most days during the past month. A minimum score of 40 of 100 on a visual analogue scale VAS at baseline is an inclusion requirement
4. Willingness to be randomly assigned, understanding and signing the informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Patients are screened by blood tests (rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), etc) to rule out the possibilities of rheumatoid arthritis
2. Patients with fibromyalgia syndrome, and chronic fatigue syndrome, and ankylosing spondylitis are excluded to rule out their impact on outcome assessment
3. Use of steroid medication in the past 3 months
4. Acupuncture or moxibustion treatment received in the previous 3 months
5. Intra-articular hyaluronate injection during the past 6 months
6. Arthrocentesis or arthroscopy in the past 1 year
7. Previous history of knee/hip replacement surgery, and plan to have such surgery during the trial
8. Use of other external treatment like topical use of medication
9. Presence of serious medical conditions, including heart diseases, pulmonary diseases, kidney diseases, liver diseases or malignant tumors, systemic infection or contagious diseases and psychopathy
10. Use of trial drug in the past 30 days
11. Previous participation in other sham-controlled laser therapy
12. Recruited in other clinical trial simultaneously
13. Unable to fill measurement questionnaires
Recruitment start date
01/12/2014
Recruitment end date
30/06/2018
Locations
Countries of recruitment
China
Trial participating centre
Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
185 Puan Road
Luwan district
Shanghai
200021
China
Trial participating centre
Renji Hospital affiliated to Shanghai Jiaotong University (Pudong Branch)
2000 Jiangyue Road
Pudong new district
Shanghai
201112
China
Trial participating centre
Shanghai East Hospital affiliated to Tongji University
150 Gimo Road
Pudong new district
Shanghai
200120
China
Trial participating centre
Shanghai Tongren Hospital affiliated to Shanghai Jiaotong University
Shanghai
200336
China
Trial participating centre
Shanghai Hudong Hospital
95 Boxing Rd
Pudong new district
Shanghai
200129
China
Sponsor information
Organisation
Shanghai University of Traditional Chinese Medicine (China)
Sponsor details
1200 Cailun Road
Pudong new district
Shanghai
-
China
+86 (0)21 51322042
kyctcm@vip.sina.com
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Natural Science Foundation of China (81320108028)
Alternative name(s)
National Science Foundation of China, Natural Science Foundation of China, Chinese National Science Foundation, NSFC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
China
Funder name
National Basic Research Program of China (2015CB554505)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Key Project of State Administration of Traditional Chinese Medicine of China (ZYSNXD-CC-ZDXK-07)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 Ke Cheng (cheng_ker@hotmail.com).
Intention to publish date
31/12/2019
Participant level data
Available on request
Basic results (scientific)
Publication list