Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis

G

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status

Unknown

Conditions

Hand Osteoarthritis

Treatments

Other: Electroacupuncture
Drug: Topical diclofenac sodium gel

Study type

Interventional

Funder types

Other

Identifiers

NCT04402047
2020-015-KY

Details and patient eligibility

About

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.

Enrollment

108 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

108 participants in 2 patient groups

Electroacupuncture group
Experimental group
Treatment:
Other: Electroacupuncture
Topical DSG group
Active Comparator group
Treatment:
Drug: Topical diclofenac sodium gel

Trial contacts and locations

1

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Central trial contact

Zhishun Liu, MD, PhD; weiming wang, MD, PhD

Data sourced from clinicaltrials.gov

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