Deep Versus Superficial Heating in Patients With Knee Osteoarthritis: a Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale)
研究概览
简要总结
Heat therapy is frequently prescribed to patients with symptomatic knee osteoarthritis (OA). Deep hyperthermia via localized microwave diathermy is effective in several musculoskeletal painful conditions. However, the efficacy of superficial heating is controversial. Furthermore, no clinical trials have yet directly compared the effects of these treatment modalities in knee OA. Hence, the purpose of the present study is to compare the effects of deep and superficial hyperthermia, induced via microwave diathermy and hot packs, respectively, on pain and function in patients with symptomatic knee OA.
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
- Triple (Participant, Investigator, 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
- •Men and women aged 18 years or older
- •Moderate, mono or bilateral knee osteoarthritis
- •Pain lasting for at least three weeks
排除标准
- •Inability or unwillingness to sign informed consent
- •Previous surgery on the affected knee
- •Intra-articular injections with steroids or hyaluronic acid in prior 6 months
- •Physical therapy for knee problems in prior 6 months
- •Congenital or acquired inflammatory or neurological (systemic or local) diseases involving the knee
- •Chronic NSAID or steroid treatment
- •Cognitive or psychiatric disorders
- •Pregnancy or breastfeeding
- •Contraindications to hyperthermia (cancer in prior 2 years or active cancer treatment, local thrombosis, impaired arterial circulation, altered cutaneous thermal sensitivity, local infections or systemic acute infections, metal implants or prosthesis, severe osteoporosis
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale)
时间窗: 12 months
次要结局
- Pain visual analogue scale (VAS)(6 months)
- British Medical Research Council (BMRC) rating scale(6 months)
研究者
Carlo Bertolini
Principal Investigator
Catholic University of the Sacred Heart