Acupuncture vs Sham Acupuncture for Hand Osteoarthritis

NCT05267093 | Recruiting

• 1 other identifier: 2021-131-KY
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The proportion of responders according to the Outcome Measures in Rheumatological Clinical Trials (OMERACT) and Osteoarthritis Research Society International (OARSI) responder criteria.

  Participants that meet at least one of the following criteria are considered as responders: 1) at least a 50% decrease and change from baseline≥20 in VAS score; 2) at least a 50% decrease and change from baseline≥20 in Australian Canadian Osteoarthritis Hand Index (AUSCAN); 3) at least a 20% decrease and change from baseline≥10 in at least two measurements of VAS score, AUSCAN and global assessment.

  week 5

Secondary Outcomes (12)

• The proportion of responders according to the Outcome Measures in Rheumatological Clinical Trials (OMERACT) and Osteoarthritis Research Society International (OARSI) responder criteria.

  week 8 and week 16

• Change in average overall finger joints pain intensity in the dominant hand over the past 48h from baseline.

  week 5, week 8 and week 16

• Change in maximal overall finger joints pain intensity in the dominant hand over the past 48h from baseline.

  week 5, week 8 and week 16

• The proportion of participants achieving at least a 15-point reduction in average overall finger joints pain intensity in the dominant hand from baseline

  week 5, week 8 and week 16

• Change in Australian Canadian Osteoarthritis Hand Index (AUSCAN) total score, and pain, stiffness and physical function subscales from baseline.

  week 5, week 8 and week 16

Other Outcomes (4)

• Participants' expectations for acupuncture at baseline.

  baseline

• Blinding assessment

  immediately after the intervention

• Self-reported consumption of acetaminophen for hand OA.

  during weeks 1-4, weeks 5-8 and weeks 9-16

Study Arms (2)

Acupuncture group

EXPERIMENTAL

Participants in acupuncture group will receive treatment at bilateral Baxie (EX-UE9), bilateral Houxi (SI3), bilateral Waiguan (TE5) and Ashi points. The acupuncture treatment will last 30mins for each session, 3 sessions a week (ideally every other day) for a succession of 4 weeks.

Procedure: Acupuncture

Sham acupuncture group

PLACEBO COMPARATOR

Participants in sham acupuncture group will receive treatment at bilateral Baxie (EX-UE9), bilateral Houxi (SI3), bilateral Waiguan (TE5) and Ashi points. The sham acupuncture treatment will last 30mins for each session, 3 sessions a week (ideally every other day) for a succession of 4 weeks.

Procedure: Sham acupuncture

Interventions

Acupuncture PROCEDURE

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.

Acupuncture group

Sham acupuncture PROCEDURE

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.

Sham acupuncture group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

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

Beijing, China

RECRUITING

Related Publications (1)

• Wang W, Shi H, Liu Y, Sun Y, Chen Y, Liu Z. Efficacy and safety of acupuncture for hand osteoarthritis: study protocol for a multi-center, randomized, sham-controlled clinical trial. J Orthop Surg Res. 2023 Feb 6;18(1):89. doi: 10.1186/s13018-023-03570-6.

  PMID: 36747297 DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Weiming Wang, Ph.D

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiming Wang, Ph.D

CONTACT

+8613426424993; wangweiming1a1@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2022
• First Posted: March 4, 2022
• Study Start: April 26, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: It depends
• Access Criteria: It depends

Locations

CN (1)