- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03966248
Chinese Tuina Therapy for Treatment of Knee Osteoarthritis
Chinese Tuina (Chinese Massage and Manipulation Therapy) for KOA: A Randomized, Parallel, Physical Therapies Active Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will be randomly allocated to one of two groups. In the Chinese Tuina group (group CTG), patients will receive the traditional Chinese Tuina therapy (including rolling, grasping, scratching, pressing, acupressure or pushing) on the basis of KOA health education and home-exercise. Patients in the Physical Manual group (group PMG) will receive the modern physical manual therapy (including joint mobilization/manipulation, manual traction, soft tissue manipulations, passive stretching, range of motion and strength training) on the basis of KOA health education and home-exercise. Assessments will be conducted at baseline and 4 and 16 weeks after randomization.
It is expected that the interventions will alleviate the sufferings of the patient. The risks of participation are minimal. Occasionally, tuina can make people feel nauseous or experience a temporary increase in pain either during or after treatment. Rare side effects happen during and after Tuina or manual treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China
- Dongzhimen hospital affiliated to Bejing University of Chinese Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of KOA;
- Age 40-75 years;
- KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ in recent 3 months;
- NRS score of pain at least more than 4 points;
- Single/bilateral knee pain, duration of more than 6 month; If the patient has KOA on both legs, the heavier leg is selected for study.
Exclusion Criteria:
- Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy);
- Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.);
- Oral administration of hormones within 3 month, intra-articular injection within 6 months, knee injuries or open injuries within 6 months, or knee arthroscopy within 1 year.
- Severe acute/chronic organic or mental diseases;
- Pregnant women, pregnant and lactating women;
- Coagulation disorders (such as hemophilia, etc.), or the skin diseases at the site of operation;
- Device support treatment after knee osteoarthritis disability;
- Participation in another clinical study in the past 3 months;
- History of receiving acupuncture, massage, manipulation, or any medical plaster treatment within 3 months
- Breaks for treatment longer than 3-4 weeks depending on each circumstance or merit may be construed as non-compliance and may be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Chinese Tuina group (CTG)
The participants in CT group will receive the traditional Chinese Tuina therapy on the basis of KOA health education and home-exercise.
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This group receives 8 treatments over a 3 week period with a one week follow-up on site and a 3 month follow-up by mail, phone or email. |
ACTIVE_COMPARATOR: Physical Manual group (PMG)
The participants in PM group will receive the modern physical manual therapy on the basis of KOA health education and home-exercise.
|
This group receives 8 treatments over a 3 week period with a one week follow-up on site and a 3 month follow-up by mail, phone or email. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time Frame: Change from baseline at 4 weeks
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Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.
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Change from baseline at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time Frame: Change from baseline at 8 weeks and 16 weeks
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Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.
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Change from baseline at 8 weeks and 16 weeks
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Change in Numeric Knee Pain Rating Scale
Time Frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks
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Subjects will rate their worst knee pain in the last 24 hours using an 11 point numeric pain rating scale with 0 representing "no pain" and 10 representing " the worst pain imaginable".
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Change from baseline at 4 weeks, 8 weeks and 16 weeks
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Change in Patient Global Assessment (PGA)
Time Frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks
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The Patient global assessment rating is a 11 point Numeric Rating Scale in which subjects will rate the degree to which their knee condition has changed from the time treatment was initiated to the present.
The subject responds to the following query: "Please rate your overall knee's condition from the time you began treatment until now." using an 11 point numeric rating scale with 0 representing "A very great deal better" and 10 representing "A very great deal worse".
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Change from baseline at 4 weeks, 8 weeks and 16 weeks
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Change in 12-item Short Form Health Survey (SF-12)
Time Frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks
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The SF-12 is a generic health-related quality of life measure.
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Change from baseline at 4 weeks, 8 weeks and 16 weeks
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Change in 30 second time chair rise test
Time Frame: Change from baseline at 4 weeks
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Subjects will be seated with their arms crossed in front of their chest.
On the command "go" subjects will stand up and sit down for as many trials as they can in a 30 second period.
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Change from baseline at 4 weeks
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Change in Timed Up and Go Test Time
Time Frame: Change from baseline at 4 weeks
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On the command "go" subjects will stand up from a chair, walk 3 meters, turn around, return to the chair and sit down.
The time it takes to complete this task will be recorded.
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Change from baseline at 4 weeks
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Change in One Leg Standing Test
Time Frame: Change from baseline at 4 weeks
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One single-leg standing was assessed balance.
Test required the subject to stand with arms by his/her side.Timing was started when the subject raised one foot off the ground.
Timing was stopped if the subject displaced the weight-bearing foot, touched the suspended foot to the ground, used the suspended limb to support the weight-bearing limb, or reached the maximum balance time of 30 seconds.
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Change from baseline at 4 weeks
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OARSI Responder Criteria
Time Frame: At weeks 4 after randomisation.
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Responder criteria included 1) greater than or equal to 50% improvement in WOMAC pain or WOMAC function and an absolute improvement of greater than or equal to 20, or 2) improvement in at least 2 of the following 3 scores: 20% improvement in pain and absolute change ≥ 10 on WOMAC pain score, 20% improvement in pain and absolute change ≥ 10 on WOMAC function score, or moderate or greater improvement (≤ 4) on a 15 point global rating of change scale
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At weeks 4 after randomisation.
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Blinding assessment
Time Frame: At weeks 4 after randomisation.
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To test whether the participants are blinded successfully, all participants will be asked to guess which kind of treatment they received.
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At weeks 4 after randomisation.
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Credibility/Expectancy Questionnaire
Time Frame: About 5 min after the first treatment
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The credibility and expectancy of participants will be measured using the Credibility/Expectancy Questionnaire
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About 5 min after the first treatment
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Rescue medicine
Time Frame: At weeks 4, 8 and 16 after randomisation.
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Any use of pain-killers will be ascertained.
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At weeks 4, 8 and 16 after randomisation.
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Adverse events
Time Frame: At weeks 4 after randomisation.
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Adverse Event Form
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At weeks 4 after randomisation.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DZM-KY201906
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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