Placebo Response of Different Types of Sham Acupuncture for Knee Osteoarthritis

Обзор

This study aims to conduct a randomized controlled trial to investigate the difference in clinical efficacy and blinding effect between real acupuncture and various sham acupuncture techniques.

Подробное описание

This study aimed to recruit 150 patients with knee osteoarthritis from the hospital outpatient department. Random coding was generated using a computer network-based random system, and the subjects will be divided into five groups: real acupuncture, non-acupuncture at real-acupoint, shallow acupuncture at real-acupoint, shallow acupuncture at non-meridian and non-acupoint, and waiting treatment group in a 1:1:1:1 ratio. Acupuncture sessions were conducted three times a week for two weeks. Patients in the waiting treatment group did not receive acupuncture therapy during the study period but received acupuncture treatment after the trial. Outcome measures included Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score, Visual Analogue Pain (VAS) score, Massachusetts General Hospital Acupuncture Sensation Scale (MASS) needle sensation score, and blind evaluation scale. Data collection occurred at baseline, one week, and two weeks.

Вмешательства

• Другое Real Acupuncture
  Patients received 6 sessions of acupuncture (three sessions per week or every other day) for two consecutive weeks
• Другое Non-acupuncture at real-acupoint
  The acupuncture simulation device will be used to perform acupuncture at the same acupoints as those of the real acupuncture group.
• Другое Shallow acupuncture at real-acupoint
  At the same acupoint in the acupuncture group, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied
• Другое Shallow acupuncture at non-meridian and non-acupoint
  At non-meridian and non-acupoint, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied

Первичные конечные точки

• Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) [Срок оценки: 2 week]

Вторичные конечные точки (3)

• Visual analogue scale (VAS) [Срок оценки: 2 week]
• Blind Assessment Scale [Срок оценки: 2 week]
• Massachusetts General Hospital Acupuncture Sensation Scale (MASS) [Срок оценки: 2 week]

Критерии участия

Критерии включения

• Clinical diagnosis of knee osteoarthritis.
• Age over 40 years old.

Критерии исключения

• Tuberculosis, tumors, rheumatism of the knee joint, and rheumatoid arthritis.
• Sprain or trauma in the lower limb.
• Mental disorders.
• Severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease.
• Pregnancy or lactation.
• Use of physiotherapy for osteoarthritis knee pain in the past month; use of intra-articular injection of glucocorticoid or viscosupplementation in the past 6 months; received knee-replacement surgery; and positive floating patella test.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine — Nanchang
• Affiliated Hospital of Chengdu University of Traditional Chinese Medicine — Чэнду

Идентификаторы

NCT: NCT06675981 · 82305045 · 82305045

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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