Clinical trial NCT03966248: Chinese Tuina Therapy for Treatment of Knee Osteoarthritis
Official title: Chinese Tuina (Chinese Massage and Manipulation Therapy) for KOA: A Randomized, Parallel, Physical Therapies Active Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Arthritis
Massage
Tuina
Traditional Chinese medicine
Physical therapy
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
manual therapy
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
timeFrame: Change from baseline at 4 weeks
Secondary outcomes:
measure: Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
timeFrame: Change from baseline at 8 weeks and 16 weeks
measure: Change in Numeric Knee Pain Rating Scale
timeFrame: Change from baseline at 4 weeks, 8 weeks and 16 weeks
measure: Change in Patient Global Assessment (PGA)
timeFrame: Change from baseline at 4 weeks, 8 weeks and 16 weeks
measure: Change in 12-item Short Form Health Survey (SF-12)
timeFrame: Change from baseline at 4 weeks, 8 weeks and 16 weeks
measure: Change in 30 second time chair rise test
timeFrame: Change from baseline at 4 weeks
measure: Change in Timed Up and Go Test Time
timeFrame: Change from baseline at 4 weeks
measure: Change in One Leg Standing Test
timeFrame: Change from baseline at 4 weeks
measure: OARSI Responder Criteria
timeFrame: At weeks 4 after randomisation.
measure: Blinding assessment
timeFrame: At weeks 4 after randomisation.
measure: Credibility/Expectancy Questionnaire
timeFrame: About 5 min after the first treatment
measure: Rescue medicine
timeFrame: At weeks 4, 8 and 16 after randomisation.
measure: Adverse events
timeFrame: At weeks 4 after randomisation.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen hospital affiliated to Bejing University of Chinese Medicine
state: Beijing
Study officials:
affiliation: Beijing University of Chinese Medicine affiliated Dongzhimen Hospital
name: Xiyou Wang
role: PRINCIPAL_INVESTIGATOR
References: