Randomised Controlled Trial on the Efficacy of Fenugreek Wraps in Symptomatic Primary Gonarthrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
This randomised controlled trial aims to investigate the efficacy of fenugreek wraps in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be randomised into one of 3 groups and apply fenugreek wraps or diclofenac gel daily for 4 weeks or receive only usual care. Efficacy will be measured using questionnaire on pain, disability,function, quality of life and pressure pain sensitivity.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •osteoarthritis of the knee, Kellgren Lawrence stadium 2-3
- •at least 50% of days with complaints in past 3 months
- •initial pain intensity >45mm on a 100mm visual analoge scale
排除标准
- •systemic medication with corticoids or immunosuppressive drugs
- •systemic medication with chondroitinsulfate or glucosamine
- •secondary arthrosis
- •operation on the knee within the past 12 months
- •injection within 4 weeks (cortisone) or 6 months prior (hyaluronic acid)
- •severe comorbidities (tumor, psychiatric disorders etc.)
- •participation in other studies, regarding gonarthrosis
- •pregnancy, breastfeeding
研究组 & 干预措施
Fenugreek wraps
Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application
干预措施: Fenugreek wrap (Other)
Diclofenac gel
Daily application of diclofenac gel, 4 weeks application
干预措施: Diclofenac Gel (Drug)
结局指标
主要结局
Pain intensity
时间窗: 4 weeks
pain intensity measured on three 0-100mm visual analogous scales (actual, mean, worst pain)
次要结局
- Course of Pain(12 weeks)
- Pressure pain sensitivity(4 weeks)
- knee function (WOMAC)(12 weeks)
- measure yourself medical outcome profile (MYMOP)(12 weeks)
- Pain intensity(12 weeks)
- Quality of Life (SF-36)(12 weeks)
- self-efficacy (ASES-D)(12 weeks)
- physical function (30second chair test)(4 weeks)
- Adverse events Safety measure(4 weeks)
- Adverse events(12 weeks)
研究者
Petra Klose
PhD
Universität Duisburg-Essen