Chinese Tuina Therapy for Treatment of Knee Osteoarthritis

NCT ID: NCT03966248

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-19
• Study Completion Date: 2021-10-07

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Chinese Tuina therapy

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Physical Manual therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing University of Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Changhe Yu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiyou Wang

Role: PRINCIPAL_INVESTIGATOR

Beijing University of Chinese Medicine affiliated Dongzhimen Hospital

Locations

Dongzhimen hospital affiliated to Bejing University of Chinese Medicine

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40200237 (View on PubMed)

Other Identifiers

DZM-KY201906

Identifier Type: -

Identifier Source: org_study_id