Study for the Mechanism of Central Analgesia in Patients with Knee Osteoarthritis by Tuina Based on Brain Magnetic Resonance Imaging

Phase 1

• Conditions: Knee osteoarthritis

• Registration Number: ITMCTR2000002941
• 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. KOA chronic pain subjects inclusion criteria
(1) Meet the diagnostic criteria of traditional Chinese and Western medicine for knee osteoarthritis;
(2) Aged 18 to 65 years old male and female, right-handed;
(3) Kellgren-Lawrence radiological score is I-II;
(4) Knee joint pain lasts for more than 3 months; VAS score >=3 points;
(5) Occupation: non-physical workers (such as teachers, employees of enterprises and institutions, etc.), no violent lower extremity activities;
(6) Understand and agree to participate in this study and sign the informed consent.
2. Inclusion criteria for asymptomatic KOA subjects
(1) Once met the diagnostic criteria of traditional Chinese and Western medicine for knee osteoarthritis;
(2) Aged 18 to 65 years old male and female, right-handed;
(3) Kellgren-Lawrence radiological score is I-II;
(4) Knee joint has no pain in the last 3 months; VAS score = 0;
(5) Occupation: Non-physical workers (such as teachers, employees of enterprises and institutions, etc.), no violent lower limb activities in daily life;
(6) Understand and agree to participate in this study and sign the informed consent.
3. Healthy subjects:
(1) Aged 18 to 65 years old male and female;
(2) good health;
(3) Right-handed.

Exclusion Criteria

KOA chronic pain subjects:
1. Take painkillers or anesthetics in the last 1 month;
2. who received any other treatment within the last 1 month;
3. pregnant or lactating women;
4. suffer from mental illness, neurological disease, infectious disease, gastrointestinal disease, cardiovascular and cerebrovascular disease, immunological disease, respiratory disease or kidney disease;
5. have tumors, tuberculosis, rheumatism or rheumatoid arthritis, gout, joint trauma, or any other chronic pain symptoms, or have a history of brain trauma with loss of consciousness;
6. Patients with MRI contraindications such as atresia, pacemaker, defibrillator, cardiac stent, and intrauterine device;
7. Defects or ulcers on the skin around the knee joint;
Asymptomatic KOA subjects:
1. Patients with MRI contraindications such as atresia, pacemaker, defibrillator, cardiac stent, and intrauterine device;
2. Use of antipyretic, analgesic, sleeping or hormone drugs in the last week;
3. Pain occurred in the last 1 month;
4. History of cardiovascular, cerebrovascular, central nervous system disease, mental illness or head trauma.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Based on VBM analysis indicators;WOMAC scale;McGill Pain Questionnaire;Based on fMRI analysis indicators;Based on DTI analysis indicators;VAS pain score;

Secondary Outcome Measures

Name	Time	Method
Interpersonal Response Index Scale;Muscle tension;Hamilton Anxiety Scale (HAMA);Pain domain;Hamilton Depression Scale (HAMD);SF-36 scale;HAD scale;Lysholm scale;Chinese Emotional Quotient Questionnaire;Chinese pain sensitivity scale;