Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis

Last updated: October 6, 2020
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

N/A

Clinical Study ID

NCT04402047
2020-015-KY
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. History of hand OA for at least 3 months before enrolment and use of a NASID for ≥ 1episode of pain;

  2. Reported an average possible overall finger joints pain intensity in the dominant handover 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 NSAIDsat the screening had to have an increase in pain in the dominant hand of ≥ 20 mmduring washout);

  3. Posterior-anterior radiographs had to show Kellgren-Lawrence grade 1, 2, or 3 changesin symptomatic joints;

  4. Rheumatoid factor and anticyclonic citrullinated peptide were negative in all eligibleparticipants to exclude inflammatory arthritis;

  5. Ability to comply with the study protocol, understand the medical information forms aswell as having signed informed consent.

Exclusion

Exclusion Criteria:

  1. History or current evidence of secondary OA(due to causes other than a solelydegenerative joint disease) or symptomatic OA at additional locations besides thehand(s) requiring treatment, or any painful syndrome of the upper limb which mayinterfere with evaluation of hand pain;

  2. History of inflammatory arthritis(e.g., rheumatoid arthritis (RA), psoriaticarthritis), hemochromatosis, metabolic, or neuropathic arthropathies;

  3. History of trauma, dislocation or operation to the hand or arm in the previous 3months;

  4. Hand pain and stiffness due to tissue scarring or tendinitis;

  5. Skin damage or serious skin disorders in the hands;

  6. Intake of antidepressants, anticonvulsants, vascular or narcotics during the 10 daysprior to beginning the study;

  7. Oral, intramuscular, intra-articular or intravenous corticosteroids, or hyaluronicacid injection within 3 months preceding enrollment;

  8. Serious uncontrolled medical conditions such as cancer, uncontrolled cardiovasculardisorder, severe hepatic/renal insufficiency or coagulation disorder;

  9. Known allergy, contraindication or intolerance to diclofenac, acetaminophen, or gelcomponents;

  10. Known phobic to acupuncture or received acupuncture treatment within 4 weeks prior toenrollment.

Study Design

Total Participants: 108
Study Start date:
September 01, 2020
Estimated Completion Date:
February 28, 2023

Connect with a study center

  • Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital

    Beijing,
    China

    Active - Recruiting

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