Effectiveness and safety of the infrared ceramic graphene moxibustion device for knee osteoarthritis: study protocol for a Zelen-design randomized controlled non-inferiority clinical trial

Phase 1

• Conditions: Knee Osteoarthritis

• Registration Number: ITMCTR2200006735
• Lead Sponsor: Beijing 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) Diagnosed with KOA according to the American College of Rheumatology criteria(ACR)
(2) Aged 40-70 years
(3) Average pain score of 4 or more out of 10 on a numeric rating scale
(4) average severity score of 48 or less on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
(5) Standard radiographs Kellgren and Lawrence (K&L) grade II or III
(6) Written informed consent
Participants who concomitant meet the above 6 items can be included in the trial.

Exclusion Criteria

(1) Received knee surgery in the past 6 months or waiting for surgery
(2) Received acupuncture treatment for KOA in the past 3 months
(3) Received intra-articular injection for KOA in the past 6 months
(4) Received arthroscopy for KOA in the past year
(5) Had other diseases, infections or traumatic injuries that can cause knee pain
(6) Severe Hypotensive Spinal Anesthesia: Respiratory, Metabolic, Hepatic, Renal and Cerebral Effects.
Any one of the above items shall be excluded.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
the Numeric Rating Scale for Pain (NRS Pain);

Secondary Outcome Measures

Name	Time	Method
6-min walking test (6MWT);Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC);knee circumference;SF-36;