Moxibustion for Knee Osteoarthritis: a Randomized Pilot Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- knee pain measured by Western Ontario MacMaster (WOMAC) pain subscale
研究概览
简要总结
This study aims to assess the feasibility, effectiveness and safety of moxibustion for symptom management and function improvement in patients with knee osteoarthritis, compared to usual care group.
详细描述
Knee osteoarthritis (OA) is a common joint disease and a leading cause of pain and physical disability in older people. Its symptoms, including pain and physical disability, significantly affect patient's quality of life, and increased depression has been observed in patients with greater pain due to knee OA. Current management options include exercise, weight reduction, Non-steroidal anti-inflammatory drugs (NSAIDs) and other pain medication, intra-articular injections of steroid or hyaluronan, arthroscopic surgery and joint replacement. Except exercise and weight reduction, no known interventions have shown definitive evidence of benefits and safety for knee OA. Thus, it is still worth exploring effective and safe management options for knee OA patients.
Moxibustion is one of traditional Asian medicine using the heat stimulation by burning mugwort (mainly Artemisia vulgaris or Artemisia argyi) on acupuncture points, and regarded as a subtype of acupuncture. Previous literatures reported its use on chronic conditions including gastrointestinal disease, hypertension, musculoskeletal pain, cancer care, gynecological conditions and stroke rehabilitation solely or in combination with routine care or other traditional medicine. However, studies adequately evaluating effects and safety of moxibustion for patients with knee OA are insufficient. Given the gaps between little evidence for effects and safety of moxibustion for knee osteoarthritis and its wide use in clinical practice, the investigators attempted to assess the feasibility, effectiveness and safety of moxibustion for patients with knee osteoarthritis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 40 to 70 years old
- •Average daily knee pain over 40 points (0-100 point scale)
- •diagnosed as knee osteoarthritis according to ACR criteria
排除标准
- •Current of past history of inflammatory disease including rheumatoid arthritis
- •Traumatic injury which might be related to current knee pain
- •Autoimmune disease
- •significant deformity of knee joints
- •knee replacement surgery on affected knee
- •knee arthroscopy within 2 years
- •steroid injection in knee joints within 3 months
- •viscosupplement injections in knee joints within 6 months
- •joint fluid injection within 6 months
- •received acupuncture, moxibustion, cupping or herbal medicine within 4 weeks
- •uncontrolled hypertension
- •diabetes mellitus requiring insulin injection
- •life-threatening cardiovascular or neurological events within one year
- •chronic respiratory disease
- •hemorrhagic disorder
- •alcohol or drug addition
- •active infectious disease including tuberculosis
- •keloidosis
结局指标
主要结局
knee pain measured by Western Ontario MacMaster (WOMAC) pain subscale
时间窗: 4 weeks from baseline
The primary outcome is the knee pain measured by WOMAC pain subscale at 4 weeks from baseline.
次要结局
- The change from baseline to 4, 8 and 12 weeks in the Short Form Health Survey (SF)-36(at base line, 4 ,8 and 12 weeks later after allocation)
- The change from baseline to 4, 8 and 12 weeks in the Beck Depression Inventory(BDI)(at base line, 4 ,8 and 12 weeks later after allocation)
- The change from baseline to 4, 8 and 12 weeks in the Patient global assessment(4 ,8 and 12 weeks later after allocation)
- The change from baseline to 4, 8 and 12 weeks in the physical performance test(at a baseline, 4 ,8 and 12 weeks later after allocation)
- The change from baseline to 4, 8 and 12 weeks in the Numeric Rating Scale (NRS) for pain(at a baseline, 4 ,8 and 12 weeks later after allocation)
- The change from baseline to 4, 8 and 12 weeks in the Safety measurement(at a baseline, 4 ,8 and 12 weeks later after allocation)
- The change from baseline to 4, 8 and 12 weeks in the other WOMAC subscale and global score(at base line, 4 ,8 and 12 weeks later after allocation)