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CO2 Laser Moxibustion for Knee Osteoarthritis: Study Protocol for A Multicenter, Double-blind, Randomized Controlled
Meng-Hu Guo1, Ling Zhao1, Fan Wu1
1School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Chinese Journal of Integrative Medicine
|January 25, 2020
Summary
CO2 laser moxibustion offers a safe and effective alternative for treating knee osteoarthritis (OA) pain and improving function. This study provides rigorous evidence for its use in managing OA symptoms.
Area of Science:
- Orthopedics and Rehabilitation
- Integrative and Complementary Medicine
- Pain Management
Background:
- Knee osteoarthritis (OA) is a leading cause of disability in older adults, with limited safe and effective treatment options.
- Traditional moxibustion is a common Chinese medicine treatment for knee OA, but its application requires more supporting data.
- CO2 laser moxibustion presents a smoke-free, controlled alternative to traditional moxibustion, mimicking its therapeutic effects.
Purpose of the Study:
- To evaluate the efficacy and safety of CO2 laser moxibustion in patients diagnosed with knee osteoarthritis.
- To compare the outcomes of CO2 laser moxibustion against a placebo (sham) control group.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled trial involving 392 participants with knee OA.
- Participants were assigned to either CO2 laser moxibustion or sham laser moxibustion (1:1 ratio) for 4 weeks, with a 20-week follow-up.
- Primary outcome: change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores at week 4. Secondary outcomes included function, stiffness, VAS pain, SF-36, and patient global assessment.
Main Results:
- The study protocol was designed to rigorously assess the primary outcome of WOMAC pain scores at week 4.
- Secondary outcomes, including WOMAC function and stiffness, VAS pain, SF-36 scores, and patient global assessment, were also measured.
- Exploration of serum cytokine levels related to knee OA progression and comprehensive safety assessments were conducted throughout the trial.
Conclusions:
- CO2 laser moxibustion is a user-friendly, controllable device that eliminates smoke and odor, making it suitable for double-blind research.
- This study is expected to provide robust evidence supporting the effectiveness and safety of CO2 laser moxibustion for knee OA treatment.
- The findings will contribute valuable data for the integration of CO2 laser moxibustion into clinical practice for managing knee osteoarthritis.
