Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis

  • STATUS
    Recruiting
  • End date
    Feb 28, 2023
  • participants needed
    108
  • sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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Updated on 25 January 2021
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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 interphalangeal (PIP) and first carpometacarpal (CMC) joints. Symptomatic hand OA is estimated to affecting 15.9% of women and 8.2% of men in the general population with a variable disease course, occurring more frequently in the elderly. Many factors including age, gender, obesity, genetic predisposition, joint deformity, joint hypermobility, and trauma are implicated in the development of hand OA. In addition to pain and stiffness, patients with hand OA often suffer from the reduced grip and pinch strength, decreased range of motion in involved and noninvolved joints, and difficulty performing dexterous tasks, resulting in disability in activities of daily living and considerable frustration.

At present, no therapies can completely cure hand OA and few therapeutic options with proven effectiveness for hand OA exist. Diclofenac sodium gel (DSG) is one of the commonly used topical NSAIDs, which can provide local pain relief for patients with hand OA with reduced systemic exposure, potentially reducing the risk of adverse events (AE). Acupuncture is effective in a host of pain-related conditions, ranging from low back pain, neck pain, shoulder pain, migraine to pain from knee OA. The research on the effects of acupuncture in people with hand OA is very limited.

The purpose of this study is to investigate the clinical effectiveness of 4-week electroacupuncture(EA) compared to topical DSG in the treatment of hand OA. Our primary hypothesis was that EA would result in a greater pain relief improvement in hand OA compared with topical DSG.

Details
Condition Hand Osteoarthritis
Treatment Electroacupuncture, Topical diclofenac sodium gel
Clinical Study IdentifierNCT04402047
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences
Last Modified on25 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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