Acupuncture vs Sham Acupuncture for Hand Osteoarthritis

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Acupuncture
  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,
• Процедура Sham acupuncture
  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 wil

Первичные конечные точки

• The proportion of responders according to the Outcome Measures in Rheumatological Clinical Trials (OMERACT) and Osteoarthritis Research Society International (OARSI) responder criteria. [Срок оценки: week 5]

Вторичные конечные точки (12)

• The proportion of responders according to the Outcome Measures in Rheumatological Clinical Trials (OMERACT) and Osteoarthritis Research Society International (OARSI) responder criteria. [Срок оценки: week 8 and week 16]
• Change in average overall finger joints pain intensity in the dominant hand over the past 48h from baseline. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: week 5, week 8 and week 16]
• Change in Functional Index for HOA (FIHOA) from baseline. [Срок оценки: week 5, week 8 and week 16]
• Change in the number of self-reported painful joints and painful joints at digital pressure from baseline. [Срок оценки: week 5, week 8 and week 16]
• Change in the number of swollen joints from baseline. [Срок оценки: week 5, week 8 and week 16]
• Change in hand grip strength of the fingers from baseline. [Срок оценки: week 5, week 8 and week 16]
• Change in pinch strength of the fingers from baseline. [Срок оценки: week 5, week 8 and week 16]
• Change in patient global assessment of improvement from baseline. [Срок оценки: 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. [Срок оценки: week 5, week 8 and week 16]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang — Пекин

Публикации

• 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

Идентификаторы

NCT: NCT05267093 · 2021-131-KY

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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