Safety and effectiveness of Traditional Chinese Medicine manipulation in early rehabilitation after arthroscopic debridement for knee osteoarthritis: a prospective randomized controlled study

Phase 1

Recruiting

• Conditions: Knee Osteoarthritis

• Registration Number: ITMCTR2100004762
• Lead Sponsor: The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Participant is willing and able to give informed consent for participation in the trial.
2. According to the clinical diagnostic criteria of the American Rheumatism Association in 1986, diagnosed with knee OA.
3. Radiographic evidence of mild-to-moderate knee osteoarthritis (Kellgren-Lawrence grade 1-3).
4. Suffering from one or more specific mechanical symptoms caused by loose bodies and/or meniscus tears within 3 months.
5. No gender limits, aged 50-75 years.
6. Able and willing to comply with all test requirements.

Exclusion Criteria

1. A participant with stiffness or instability of the knee.
2. A participant with severe acute/chronic mental diseases, anxiety or depression.
3. A participant with tumor, infection, rheumatoid arthritis, other immune or inflammatory diseases.
4. A participant with severe osteoporosis.
5. A participant with histories of fracture or surgical procedure on the affected knee.
6. A participant with hemorrhagic diseases or coagulopathy.
7. A participant with severe hypertension, arhythmia or other cardio-cerebro vascular disease.
8. A participant with history of receiving massage, manipulation, acupuncture, sodium hyaluronate or corticosteroid injection, or any other invasive therapy within 3 months.
9. Pregnant or lactating women.
10. A participant who have participated in another clinical study which may influence the result of the trial in the past 3 months.
11. MRI showing specific signals characteristic of subchondral edema.
12. Arthroscopically-verified full-thickness cartilage defect or marked chondral flap in the weight-bearing area.
13. Meniscal repair, notchplasty or removal of osteophytes, any form of cartilage augmentation or removal of chondral flaps, microfracture, or extensive synoviectomy was performed in the arthroscopic surgery.
14. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ysholm Knee Score;Incidence of wound complications;

Secondary Outcome Measures

Name	Time	Method
Quadriceps and hamstring peak torques;Satisfaction of patients;Pain at thigh and knee (Visual Analogue scale);Thigh circumference 10cm above the patella;Incidence of other adverse reactions (Such as cardiovascular accident, joint deep infection, etc.);Frequency of mechanical symptoms (per week);Western Ontario and McMaster Universities Arthritis Index;Range of knee motion;