Chinese Tuina Therapy for Treatment of Knee Osteoarthritis

NCT03966248 | Completed

• 1 other identifier: DZM-KY201906
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Arthritis; Massage; Tuina; Traditional Chinese medicine; Physical therapy; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; manual therapy

Outcome Measures

Primary Outcomes (1)

• Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

  Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.

  Change from baseline at 4 weeks

Secondary Outcomes (12)

• Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

  Change from baseline at 8 weeks and 16 weeks

• Change in Numeric Knee Pain Rating Scale

  Change from baseline at 4 weeks, 8 weeks and 16 weeks

• Change in Patient Global Assessment (PGA)

  Change from baseline at 4 weeks, 8 weeks and 16 weeks

• Change in 12-item Short Form Health Survey (SF-12)

  Change from baseline at 4 weeks, 8 weeks and 16 weeks

• Change in 30 second time chair rise test

  Change from baseline at 4 weeks

Study Arms (2)

Chinese Tuina group (CTG)

EXPERIMENTAL

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

Physical Manual group (PMG)

ACTIVE COMPARATOR

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

Interventions

Chinese Tuina therapy OTHER

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.

Chinese Tuina group (CTG)

Physical Manual therapy OTHER

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.

Physical Manual group (PMG)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead

Study Sites (1)

Dongzhimen hospital affiliated to Bejing University of Chinese Medicine

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• Ma P, Liu L, Li S, Cai M, Han S, Weng Z, Chen Q, Gao Y, Zhang L, Wu G, Yang X, Zhang Y, Li D, Liu C, Sun Y, Yan S, Wang X, Yu C. Comparative effectiveness of Tuina therapy versus manual physical therapy for knee osteoarthritis: a randomized controlled trial. BMC Complement Med Ther. 2025 Apr 8;25(1):128. doi: 10.1186/s12906-025-04850-w.

  PMID: 40200237 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Osteoarthritis; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xiyou Wang

  Beijing University of Chinese Medicine affiliated Dongzhimen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2019
• First Posted: May 29, 2019
• Study Start: October 19, 2019
• Primary Completion: October 7, 2021
• Study Completion: October 7, 2021
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)