Efficacy of Focused Shock Waves Combined With Adjuvant Therapy With Tendon Supplement in the Treatment of Plantar Fasciitis: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in Visual Analogue Score (VAS)
研究概览
简要总结
Physical treatment with focused shock waves is effective in the treatment of tendonitis. Food supplements could facilitate the healing of tendinopathies when combined with shock wave therapy.
详细描述
A single-blind, randomized prospective study (level of evidence IB) was designed. Patients with plantar fasciitis were recruited and randomized to group A and group B. Group A was treated with focused shock waves alone and group B with a combination of focused shock waves and tendon supplement. Pain remission (primary endpoint) and functional recovery (secondary endpoint) are monitored in both groups at three time points (Months 0, 3, and 6).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •plantar heel pain diagnosed clinically and instrumentally (ultrasound) as plantar fasciitis, that has not responded to conservative treatment for at least six months;
排除标准
- •History of previous fractures or ankle and heel surgery;
- •Recurrence of previous local painful episodes;
- •Lesion of the plantar fascia on US examination;
- •Presence of pathologies that affect the function of the foot (lumbar radiculopathy, Achilles tendinitis, Morton's neuroma, etc.);
- •Chronic inflammatory conditions such as psoriasis, psoriatic arthritis, spondyloarthritis, ankylosing spondylitis, rheumatoid arthritis, chronic inflammatory bowel disease.
结局指标
主要结局
Change in Visual Analogue Score (VAS)
时间窗: T1 (three months); T2 (six months)
The pain was quantified using the VAS scale with the scores ranging between 0 (no pain)
次要结局
- Change in American Foot & Ankle Score (AOFAS)(T0 (recruitment); T2 (six months))
- Roles & Maudsley (R&M)(T2 (six months))
- Change in Foot Function Index (FFI)(T0 (recruitment); T2 (six months))