Acupuncture vs Sham Acupuncture for Hand Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hand Osteoarthritis

Intervention / Treatment
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* Procedure: Acupuncture
* Procedure: Sham acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br>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<br>* 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.<br>|
| Placebo Comparator: Sham acupuncture group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 8 and week 16 | 
| 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. | 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. | Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain. | 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 | Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain. | 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. | The AUSCAN index contains a 15-item scale referring to hand pain (5 items), stiffness (1 item), and function (9 items) during the preceding 48 hours, which is valid, reliable and responsive in patients with hand OA. All items are scaled on a 0-100 VAS (0=none to 100= very severe), with higher scores indicating more severe symptoms/function. | week 5, week 8 and week 16 | 
| Change in Functional Index for HOA (FIHOA) from baseline. | The FIHOA is a patient-reported hand function questionnaire, comprising 10 items with a four-point Likert scale, in which 0 represents possible without difficulty, 1 indicates possible with slight difficulty, 2 represents possible with important difficulty and 3 indicates impossible. | week 5, week 8 and week 16 | 
| Change in the number of self-reported painful joints and painful joints at digital pressure from baseline. | All finger joints will be reported spontaneously for the presence of pain by the participants, and examined by a trained research nurse for the presence of pain at digital pressure. | week 5, week 8 and week 16 | 
| Change in the number of swollen joints from baseline. | All soft swollen finger joints count (0-30) will be assessed by a trained research nurse at each study visit. | week 5, week 8 and week 16 | 
| Change in hand grip strength of the fingers from baseline. | Hand grip strength of the fingers of the dominant hand will be tested using a hand dynamometer. | week 5, week 8 and week 16 | 
| Change in pinch strength of the fingers from baseline. | Hand pinch strength of the fingers of the dominant hand will be tested using a Jamar digital pinch gauge respectively. | week 5, week 8 and week 16 | 
| Change in patient global assessment of improvement from baseline. | The patients will be asked to respond to the question 'Considering all the ways your hand OA affects you, how have you been during the last 48 h?' on a self-administered 0-100 VAS (0, worst possible, to 100, best possible, in 10-point increments). | immediately after the intervention, week 8 and week 16 | 
| Change in quality of life assessed by the World Health Organization Quality of Life abbreviated version (WHOQOL-BREF) from baseline. | The WHOQOL-BREF is a 26-item self-report questionnaire rated on a 5-point Likert-type scale with four domains of QOL: physical (seven items), psychological (six items), social (three items), and environment (eight items), plus 2 items representing the general QOL. The four domain scores are scaled in a positive direction with higher scores indicating a higher quality of life. | week 5, week 8 and week 16 |