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RecruitingNCT05267093

Acupuncture vs Sham Acupuncture for Hand Osteoarthritis

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
340 (estimated)
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREAcupunctureSterile 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.
PROCEDURESham acupunctureThe 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.

Timeline

Start date
2022-04-26
Primary completion
2026-09-01
Completion
2026-12-01
First posted
2022-03-04
Last updated
2025-07-16

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05267093. Inclusion in this directory is not an endorsement.