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Chinese Tuina Therapy for Treatment of Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03966248
Recruitment Status : Completed
First Posted : May 29, 2019
Last Update Posted : January 4, 2022
Sponsor:
Information provided by (Responsible Party):
Changhe Yu, Beijing University of Chinese Medicine

Brief Summary:
Knee osteoarthritis (KOA) is one of the most common musculoskeletal diseases in clinic. It usually occurs in middle-aged people, especially women. An estimated lifetime risk for KOA is approximately 40% in men and 47% in women. KOA is a chronic disease which can lead to obvious pain, joint stiffness, limitation of activity and even disability, with significant associated costs and effects on society, health systems, and individuals. Tuina therapy has been used and showed effectiveness and safety for pain relief and disability for the patients with musculoskeletal disorders for years in China. Though it is regarded that the Traditional Chinese medicine (TCM) Tuina therapy is similar to the modern manual therapies, the modalities of TCM tuina therapy are different and effect maybe equal to or more better than the modern manual therapy in clinic. However, little evidence exists that Tuina benefits the KOA. The investigators will do this in a randomized, parallel, active controlled study to observe whether TCM Tuina is more beneficial to KOA than the physical manual therapy, which has been considered an effective and standard care for KOA.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Other: Chinese Tuina therapy Other: Physical Manual therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two arms recruit and evaluate the participants at the same time, and the included participants have the equal opportunity to either the Chinese Tuina or physical manual therapy groups.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Participants are randomly divided into Chinese Tuina group and Physical Manual group at a ratio of 1:1, only knowing that they will receive the manual therapies. The assessor, data manager and statistician will not participate in the randomized process and the treatment and share any information with each other.
Primary Purpose: Treatment
Official Title: Chinese Tuina (Chinese Massage and Manipulation Therapy) for KOA: A Randomized, Parallel, Physical Therapies Active Controlled Study
Actual Study Start Date : October 19, 2019
Actual Primary Completion Date : October 7, 2021
Actual Study Completion Date : October 7, 2021

Resource links provided by the National Library of Medicine


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.
Other: Chinese Tuina therapy
  1. The doctor presses the affected lower limb from the anterior superior iliac spine to the ankle;
  2. The doctor gives the pressure on the Biguan(ST31), Futu(ST32), Heding(EX-LE2), Neixiyan(EX-LE4), Waixiyan(Dubi, ST35), Zusanli(ST36) and Sanyinjiao(SP6) of the affected lower limb;
  3. Massage the spleen and stomach meridians of the affected lower extremes;
  4. Roll the soft tissues around the affected knee;
  5. Relax the gastrocnalis muscle
  6. The doctor gives the pressure on the Xuehai(SP10), Liangqiu(ST34), Neixifeng(medial patellofemoral ligament), Waixifeng(lateral patellofemoral ligament), Neixiyan(EX-LE4) and Waixiyan(Dubi, ST35) at the same time;
  7. Push the patella and do the passive movement of the affected knee;
  8. Strength training of the affected knee.

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.
Other: Physical Manual therapy
  1. Manual therapy: Stretching the knee joint, stretching the knee joint with valgus or abduction, stretching the knee joint with varus or adduction is suitable for patients with knee flexion and extension difficulty.Patellar manipulation by bending the knee 5-10 degrees downward is suitable for patients with patellar sliding difficulty.The lower end of the muscle length manipulation is suitable for patients with muscle tension and soft tissue tension.Soft tissue loosening is performed in the suprapatellar and peripatellar regions, medial and lateral capsule joints, and popliteal fossa.
  2. Activity training: Mainly about the knee joint flexion and extension movement training.
  3. Strength training: Mainly about quadriceps muscle resistance exercises

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.





Primary Outcome Measures :
  1. Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) [ Time Frame: Change from baseline at 4 weeks ]
    Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.


Secondary Outcome Measures :
  1. Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) [ Time Frame: Change from baseline at 8 weeks and 16 weeks ]
    Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.

  2. Change in Numeric Knee Pain Rating Scale [ Time Frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks ]
    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".

  3. Change in Patient Global Assessment (PGA) [ Time Frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks ]
    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".

  4. Change in 12-item Short Form Health Survey (SF-12) [ Time Frame: Change from baseline at 4 weeks, 8 weeks and 16 weeks ]
    The SF-12 is a generic health-related quality of life measure.

  5. Change in 30 second time chair rise test [ Time Frame: Change from baseline at 4 weeks ]
    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.

  6. Change in Timed Up and Go Test Time [ Time Frame: Change from baseline at 4 weeks ]
    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.

  7. Change in One Leg Standing Test [ Time Frame: Change from baseline at 4 weeks ]
    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.

  8. OARSI Responder Criteria [ Time Frame: At weeks 4 after randomisation. ]
    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

  9. Blinding assessment [ Time Frame: At weeks 4 after randomisation. ]
    To test whether the participants are blinded successfully, all participants will be asked to guess which kind of treatment they received.

  10. Credibility/Expectancy Questionnaire [ Time Frame: About 5 min after the first treatment ]
    The credibility and expectancy of participants will be measured using the Credibility/Expectancy Questionnaire

  11. Rescue medicine [ Time Frame: At weeks 4, 8 and 16 after randomisation. ]
    Any use of pain-killers will be ascertained.

  12. Adverse events [ Time Frame: At weeks 4 after randomisation. ]
    Adverse Event Form



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of KOA;
  2. Age 40-75 years;
  3. KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ in recent 3 months;
  4. NRS score of pain at least more than 4 points;
  5. 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:

  1. Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy);
  2. Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.);
  3. 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.
  4. Severe acute/chronic organic or mental diseases;
  5. Pregnant women, pregnant and lactating women;
  6. Coagulation disorders (such as hemophilia, etc.), or the skin diseases at the site of operation;
  7. Device support treatment after knee osteoarthritis disability;
  8. Participation in another clinical study in the past 3 months;
  9. History of receiving acupuncture, massage, manipulation, or any medical plaster treatment within 3 months
  10. Breaks for treatment longer than 3-4 weeks depending on each circumstance or merit may be construed as non-compliance and may be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03966248


Locations
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China, Beijing
Dongzhimen hospital affiliated to Bejing University of Chinese Medicine
Beijing, Beijing, China
Sponsors and Collaborators
Beijing University of Chinese Medicine
Investigators
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Principal Investigator: Xiyou Wang Beijing University of Chinese Medicine affiliated Dongzhimen Hospital
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Responsible Party: Changhe Yu, Principal Investigator, Beijing University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT03966248    
Other Study ID Numbers: DZM-KY201906
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: January 4, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Changhe Yu, Beijing University of Chinese Medicine:
Arthritis
Massage
Tuina
Traditional Chinese medicine
Physical therapy
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
manual therapy
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases