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Chinese Tuina Therapy for Treatment of Knee Osteoarthritis

B

Beijing University of Chinese Medicine

Status

Completed

Conditions

Osteoarthritis, Knee

Treatments

Other: Chinese Tuina therapy
Other: Physical Manual therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03966248
DZM-KY201906

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

140 participants in 2 patient groups

Chinese Tuina group (CTG)
Experimental group
Description:
The participants in CT group will receive the traditional Chinese Tuina therapy on the basis of KOA health education and home-exercise.
Treatment:
Other: Chinese Tuina therapy
Physical Manual group (PMG)
Active Comparator group
Description:
The participants in PM group will receive the modern physical manual therapy on the basis of KOA health education and home-exercise.
Treatment:
Other: Physical Manual therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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