Sinew Acupuncture for Knee Osteoarthritis (KOA): A Randomized, Sham Controlled, Patient and Assessor Blinded, Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Pain intensity measured by VAS
研究概览
简要总结
The study aims to exam whether sinew acupuncture can relieve pain and symptoms of KOA and improve functional movement by Visual Analog Scale (VAS), Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed up & Go Test (TUG) and 8-step Stair Climb Test (SCT) assessment, and Quality of life by Short Form-36 (SF-36). A randomized, sham acupuncture controlled, patient and assessor blinded, pilot study will be employed.
详细描述
Objective:
The proposal aims to examine the efficacy and safety of sinew acupuncture for knee osteoarthritis (KOA).
Hypothesis to be tested:
Sinew acupuncture can reduce pain intensity, and improve knee function and health-related quality of life without significant side effects for KOA subjects compared to a sham acupuncture.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be randomized into sinew acupuncture group and sham acupuncture group in a 1:1 ratio.
Assessors will perform the assessment but not be involved in acupuncture treatment.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hong Kong permanent residents aged on or above 50, both male and female;
- •meet the Clinical Classification Criteria for Osteoarthritis of the Knee by history, physical examination and radiographic findings (recommended by the American College of Rheumatology): history and physical examination: pain in the knee and one of the following (
- •Over 50 years of age;
- •Less than 30 minutes of morning stiffness;
- •Crepitus on active motion and osteophytes) and radio graphical findings (Kellgren and Lawrence Grades 2-4):
- •with unilateral knee pain or bilateral knee pain;
- •in chronic stage (pain of at least 6 month's duration);
- •with rated knee pain >40 mm on a visual analog scale (VAS; 0 to 100 mm) within 7 days;
- •with X-ray or other radiographic reports are preferable (not necessary);
- •who volunteer to participate and sign the consent form;
- •able to write and read Chinese.
排除标准
- •Patients who are unable to walk;
- •with serious infection of knee;
- •with suspected tears of ligaments, menisci or acute inflammation of synovial capsule;
- •with trauma, ligament damage, fracture, or surgery on the knee(s) within 6 months, as the cause of pain or functional problems (history of knee replacement will be excluded);
- •with history of local tumor/malignancy at knee;
- •with physical or laboratory findings indicating infection, presence of autoimmune disease or inflammatory arthritis;
- •with knee pain caused by radiculopathy / herniation of intervertebral disc;
- •with end-stage of diseases and other suspected severe conditions such as deep vein thrombosis of the lower limb, edema related to cancer or cancer treatment, severe blood coagulation disorders, uncontrolled systemic arterial hypertension and severe diabetes;
- •with history of prolotherapy, with injections of hyaluronic acid or cortisone within 3 months;
- •received acupuncture, electro-acupuncture, Tui-na therapy, massage, physiotherapy for 8 weeks prior to the trial;
- •with more severe pain in other regions;
- •have severe mental disorders;
- •oversensitive to needles;
- •insensitive to pain due to advanced diabetes, neuropathy or using strong painkillers;
- •fail to be complaint with the treatment protocol.
研究组 & 干预措施
Sinew acupuncture
Subject in the arm will receive real acupuncture intervention.
干预措施: Sinew acupuncture (Other)
Sham acupuncture
Subject in the arm will receive sham acupuncture intervention.
干预措施: Sham acupuncture (Other)
结局指标
主要结局
Pain intensity measured by VAS
时间窗: Week 4
Pain intensity will be measured by VAS
次要结局
- 8-step SCT(Weeks 0, 2, 4, 6 and 10)
- WOMAC(Weeks 0, 1, 2, 3, 4, 6 and 10)
- TUG(Weeks 0, 2, 4, 6 and 10)
- Quality of life measured by SF-36(Weeks 0, 4, and 10)