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RECRUITING

NCT05267093

Acupuncture vs Sham Acupuncture for Hand Osteoarthritis

Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

View on ClinicalTrials.gov

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.

Official title: Efficacy of Acupuncture for Patients With Hand Osteoarthritis: a Randomized, Sham-controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

340

Start Date

2022-04-26

Completion Date

2026-12

Last Updated

2025-07-16

Healthy Volunteers

Conditions

Hand Osteoarthritis

Interventions

PROCEDURE

Acupuncture

Sterile single-use stainless steel needles (size 0.3 mm × 25 mm) will be utilized. After local skin disinfection with 75% alcohol wipes, acupuncturists will insert needles perpendicularly into the Ashi points to a depth of approximately 2-3 mm; horizontally into the Baxie points toward the wrist to a depth of 5-10 mm; and perpendicularly into Houxi (SI3) and Waiguan (TE5) to a depth of approximately 5-10 mm. The depth of needling will vary based on the participant's body sizes. After insertion, all needles except those in the Ashi points will be manually manipulated to achieve De qi sensations. All the needles will be retained for 30 min and then gently removed. Participants will take acupuncture treatment three times per week for a total of 12 sessions in 4 consecutive weeks.

PROCEDURE

Sham acupuncture

The sham needles with blunt tips (size 0.3 mm × 25 mm) will be used in the control group. Acupuncturists will gently lift and twist the sham needles to simulate the treatment procedure, thus blinding the patients to the intervention. Acupuncturist will firstly sterilize the areas of acupoints, then apply the adhesive pads on the surface of Ashi points, Baxie points, Houxi (SI3) and Waiguan (TE5) and insert the sham needles without penetrating. The duration and frequency of treatment sessions will be the same as in the acupuncture group.

Inclusion Criteria: * 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 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 (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.

Locations (1)

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

Beijing, China