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.
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)
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;
Parallel
Acupuncture
Procedure/SurgerySterile 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.
Sham acupuncture
Procedure/SurgeryThe 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.
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.
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.
Change in average overall finger joints pain intensity in the dominant hand over the past 48h from baseline.
Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain.
Change in maximal overall finger joints pain intensity in the dominant hand over the past 48h from baseline.
Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain.
The proportion of participants achieving at least a 15-point reduction in average overall finger joints pain intensity in the dominant hand from baseline
Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain.
Participants' expectations for acupuncture at baseline.
At baseline, participants in both groups will be asked to answer the following question: "What do you expect from EA treatment to improve your hand OA?"
Blinding assessment
All participants will be told before allocation that insertion is deeper in group A (traditional acupuncture) and shallower in group B (modern acupuncture). After treatments finished, they will be asked "Do you think you were in group A (traditional acupuncture) in the past weeks?", the answers are "Yes", "No" or "Unclear".
Self-reported consumption of acetaminophen for hand OA.
The proportion of participants using acetaminophen, and the frequency and total dosage of acetaminophen used will be calculated and assessed.
Safety assessment
Any acupuncture-associated adverse event (AE) such as dizziness, palpitations, local hematomas, or infection, and any other AE irrelevant to acupuncture, will be carefully documented.
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