Status:
UNKNOWN
Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With 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
Hand osteoarthritis (OA) is a prevalent joint disorder characterized by pain, stiffness, and bony enlargements/swellings of multiple joints, in particular distal interphalangeal (DIP), proximal interp...
Eligibility Criteria
Inclusion
- History of hand OA for at least 3 months before enrolment and use of a NASID for ≥ 1 episode of pain;
- Reported an average possible overall finger joints pain intensity in the dominant hand over the past 48 hours of at least 40mm according to a 100-mm visual analog scale (VAS) after 1-week wash-out period of previous OA medications(Patients applying NSAIDs at the screening had to have an increase in pain in the dominant hand of ≥ 20 mm during washout);
- Posterior-anterior radiographs had to show Kellgren-Lawrence grade 1, 2, or 3 changes in symptomatic joints;
- Rheumatoid factor and anticyclonic citrullinated peptide were negative in all eligible participants to exclude inflammatory arthritis;
- Ability to comply with the study protocol, understand the medical information forms as well as having signed 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(e.g., rheumatoid arthritis (RA), 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 allergy, contraindication or intolerance to diclofenac, acetaminophen, or gel components;
- Known phobic to acupuncture or received acupuncture treatment within 4 weeks prior to enrollment.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2023
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04402047
Start Date
September 1 2020
End Date
February 28 2023
Last Update
October 8 2020
Active Locations (1)
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1
Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital
Beijing, China