Status:
RECRUITING
Acupuncture vs Sham Acupuncture for Hand Osteoarthritis
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Hand Osteoarthritis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The investigators plan to conduct this multicentered, sham-controlled randomized clinical trial to evaluate the efficacy and safety of acupuncture for clinical symptomatic improvement of hand OA.
Detailed Description
Symptomatic hand osteoarthritis (HOA) is estimated to affect 15.9% of women and 8.2% of men in the general population. Since no therapy can completely cure HOA at present, alternative effective therap...
Eligibility Criteria
Inclusion
- Diagnosed as hand OA according to the American College of Rheumatology (ACR) clinical classification criteria
- History of hand OA for at least 3 months before enrollment and history of taking nonsteroidal anti-inflammatory drugs (NSAIDs) to treat hand OA
- Aged 18-80 years
- At least 40 mm in visual analog scale (VAS) on the average pain intensity of the dominant hand over the last 48 hours (patients applying NSAIDs at the screening have to have an increase in pain in the dominant hand of ≥ 20 mm after 1-week washout)
- Posterior-anterior radiographs of the dominant hand shows Kellgren-Lawrence grade 1, 2, or 3 changes in symptomatic joints
- Negative results in both rheumatoid factor and anticyclonic citrullinated peptide
- Able to comply with the study protocol and understand the medical information forms
- Voluntarily sign the informed consent
Exclusion
- History or current evidence of secondary OA (due to causes other than a solely degenerative joint disease) or symptomatic OA at additional locations besides the hand(s) requiring treatment, or any painful syndrome of the upper limb which may interfere with evaluation of hand pain;
- History of inflammatory arthritis (such as rheumatoid arthritis (RA) or psoriatic arthritis), hemochromatosis, metabolic, or neuropathic arthropathies;
- History of trauma, dislocation or operation to the hand or arm in the previous 3 months;
- Hand pain and stiffness due to tissue scarring or tendinitis;
- Skin damage or serious skin disorders in the hands;
- Intake of antidepressants, anticonvulsants, vascular or narcotics during the 10 days prior to beginning the study;
- Oral, intramuscular, intra-articular or intravenous corticosteroids, or hyaluronic acid injection within 3 months preceding enrollment;
- Serious uncontrolled medical conditions such as cancer, uncontrolled cardiovascular disorder, severe hepatic/renal insufficiency or coagulation disorder;
- Known phobic to acupuncture or received acupuncture treatment within 4 weeks prior to enrollment.
Key Trial Info
Start Date :
April 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT05267093
Start Date
April 26 2022
End Date
December 1 2026
Last Update
July 16 2025
Active Locations (1)
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1
Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital
Beijing, China