Clinical trial NCT05267093: Acupuncture vs Sham Acupuncture for Hand Osteoarthritis
Official title: Efficacy of Acupuncture for Patients With Hand Osteoarthritis: a Randomized, Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand Osteoarthritis
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Symptomatic hand osteoarthritis (HOA) is estimated to affect 15.9% of women and 8.2% of men in the general population. Since no therapy can completely cure HOA at present, alternative effective therapies are needed. Acupuncture has been an effective treatment to alleviate pain and improve joint motion for patients with knee osteoarthritis according to a considerable amount of research. It is not surprised that acupuncture is effective in treating HOA in clinical practice considering the similar pathogenesis HOA shared with knee osteoarthritis. However, the research on the effects of acupuncture in patients with HOA is very limited. The present study aims to evaluate the efficacy and safety of acupuncture for HOA.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of responders according to the Outcome Measures in Rheumatological Clinical Trials (OMERACT) and Osteoarthritis Research Society International (OARSI) responder criteria.
timeFrame: week 5
Secondary outcomes:
measure: The proportion of responders according to the Outcome Measures in Rheumatological Clinical Trials (OMERACT) and Osteoarthritis Research Society International (OARSI) responder criteria.
timeFrame: week 8 and week 16
measure: Change in average overall finger joints pain intensity in the dominant hand over the past 48h from baseline.
timeFrame: week 5, week 8 and week 16
measure: Change in maximal overall finger joints pain intensity in the dominant hand over the past 48h from baseline.
timeFrame: week 5, week 8 and week 16
measure: The proportion of participants achieving at least a 15-point reduction in average overall finger joints pain intensity in the dominant hand from baseline
timeFrame: week 5, week 8 and week 16
measure: Change in Australian Canadian Osteoarthritis Hand Index (AUSCAN) total score, and pain, stiffness and physical function subscales from baseline.
timeFrame: week 5, week 8 and week 16
measure: Change in Functional Index for HOA (FIHOA) from baseline.
timeFrame: week 5, week 8 and week 16
measure: Change in the number of self-reported painful joints and painful joints at digital pressure from baseline.
timeFrame: week 5, week 8 and week 16
measure: Change in the number of swollen joints from baseline.
timeFrame: week 5, week 8 and week 16
measure: Change in hand grip strength of the fingers from baseline.
timeFrame: week 5, week 8 and week 16
measure: Change in pinch strength of the fingers from baseline.
timeFrame: week 5, week 8 and week 16
measure: Change in patient global assessment of improvement from baseline.
timeFrame: immediately after the intervention, week 8 and week 16
measure: Change in quality of life assessed by the World Health Organization Quality of Life abbreviated version (WHOQOL-BREF) from baseline.
timeFrame: week 5, week 8 and week 16
Other outcomes:
measure: Participants' expectations for acupuncture at baseline.
timeFrame: baseline
measure: Blinding assessment
timeFrame: immediately after the intervention
measure: Self-reported consumption of acetaminophen for hand OA.
timeFrame: during weeks 1-4, weeks 5-8 and weeks 9-16
measure: Safety assessment
timeFrame: during weeks 1-4, weeks 5-8 and weeks 9-16
Locations:
city: Beijing
country: China
facility: Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Weiming Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: