Cerebral Mechanism of Tuina Analgesia in Management of Knee Osteoarthritis using multimodal MRI: a Randomized Controlled Trial

Phase 1

• Conditions: Knee osteoarthritis

• Registration Number: ITMCTR2000003897
• Lead Sponsor: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai 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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who meet the diagnostic criteria of ACR for knee arthritis in 1991;
2. Patients aged between 40 and 60 years with right hand and left knee pain;
3. Whether the I-II X-ray changes of knee joint conform to Kellgren Lawrence scale;
4. Patients with average knee pain score >=3 (range from 0 to 10) in the past three months;
5. Patients who voluntarily participated in the study and signed informed consent.

Exclusion Criteria

1. Patients who have taken analgesics or anesthetics that may affect the results of brain imaging in the past month;
2. Patients who have received other treatment in the past month;
3. Pregnant women or lactating women;
4. Patients with chronic pain symptoms such as mental disease, nervous system disease, infectious disease, gastrointestinal disease, cardiovascular disease, immune system disease, respiratory system disease or kidney disease, or history of brain injury and loss of consciousness;
5. Patients diagnosed with cancer, tuberculosis, rheumatism or rheumatoid arthritis, gout and joint trauma;
6. Patients with claustrophobia, pacemaker, defibrillator, cardiac stent, intrauterine device and other contraindications of MRI;
7. Patients with skin injury around the knee joint.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
fMRI - functional connectivity (FC);The Visual Analog Scale (VAS);structure - gray matter density, cortical thickness, subcortical nuclei volumes;diffusion - FA and MD of white matter integrity;

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC);Hamilton Depression Scale (HAMD);the Hamilton Anxiety Scale (HAMA);Short-form McGill Pain Questionnaire (SF-MPQ);the 36-Item Short Form Health Survey (SF-36);