Clinical Observation and Research on the Treatment of Knee Osteoarthritis of Damp-heat Arthralgia Type with Intelligent Temperature Control and Cold Needle

Phase 1

• Conditions: knee osteoarthritis

• Registration Number: ITMCTR2000003611
• Lead Sponsor: Shuguang Hospital Affiliated to 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) Aged 50-80 years;
(2) Meet the diagnostic criteria of western medicine for knee osteoarthritis;
(3) Those who meet the standard of TCM damp-heat arthralgia syndrome differentiation;
(4) Kellgren-Lawrence grade 0-III for knee osteoarthritis;
(5) Patients who have stopped taking NSAIDs (non-steroidal anti-inflammatory drugs) for at least 7 days;
(6) If you use disease-improving drugs (diacerein and similar drugs), you need to stop the drug for 1 month or more;
(7) Patients and their families have good compliance and signed informed consent.

Exclusion Criteria

(1) Overlap patients with other rheumatic diseases such as systemic lupus erythematosus, Sjogrens syndrome, rheumatoid arthritis, etc.;
(2) Patients with serious diseases on heart, brain, liver, kidney and hematopoietic system;
(3) Pregnant or breastfeeding women, mental patients;
(4) Patients who have participated in other clinical trials within the past four weeks.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
VAS;

Secondary Outcome Measures

Name	Time	Method
Western Ontario McMaster Universities Osteoarthritis Index;Michel Lequesen knee OA severity index;Health assessment questionnaire;TCM Syndrome Points;