Comparative Efficacy of Corticosteroid Injection, Extracorporeal Shock Wave Therapy, and Radiofrequency Ablation for Chronic Plantar Fasciitis: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS) scores
研究概览
简要总结
Chronic plantar fasciitis is a prevalent condition causing persistent heel pain, often refractory to conservative treatments. This prospective randomized controlled trial aimed to compare the effectiveness of corticosteroid injection (CSI) , extracorporeal shock wave therapy (ESWT), and radiofrequency thermal lesioning (RTL) in the management of chronic plantar fasciitis.
详细描述
Based on the investigators' understanding of the literature there are no randomized, controlled, prospective studies comparing the therapeutic effects of CSI, ESWT and RTL for recalcitrant plantar fasciitis. In this study, the investigators investigated and compared the outcomes of three treatment techniques in participants who had exhausted conservative treatment options over the past six months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistant heel pain for ≥ 6 months
- •No response to at least 6 weeks of conservative treatment (including at least two of the following: NSAIDs, stretching exercises, ice, heel pads, physical therapy, or night splints)
- •VAS ≥ 5 following the first step in the morning or after periods of prolonged inactivity
- •Willingness to participate in the study
排除标准
- •Previous foot or ankle surgery, major trauma
- •Tumor, osteomyelitis, or complex regional pain syndrome in the affected limb
- •Allergy to local anesthesia or NSAIDs
- •Pregnancy or breastfeeding
- •History of calcaneal fracture
- •Previous cortisone injection, ESWT, or RTL for similar complaints
- •Age < 18
- •Use of medications for neuropathic pain (Pregabalin, Gabapentin)
- •Proximal nerve lesion (e.g., spinal stenosis, sciatica, tarsal tunnel syndrome)
- •Regional skin or subcutaneous infections, fat pad atrophy
- •History of rheumatic disease, or hematologic conditions
- •History of peripheral vascular disease
- •Seronegative arthropathies, heart failure, hepatic or metabolic disorders
- •Pacemaker
- •History of clubfoot, pes cavus, or calcaneovalgus
- •Diabetic neuropathy
结局指标
主要结局
Visual Analog Scale (VAS) scores
时间窗: 1st month. 3rd month, 6th month
Pain score (1 to 10 points)
Foot Function Index (FFI)
时间窗: 1st month. 3rd month, 6th month,
Function score (The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales.)
Roles and Maudsley Score
时间窗: 1st month. 3rd month, 6th month,
The Roles and Maudsley score is an established subjective 4-point patient assessment of pain and limitations of activity (1 = excellent result with no symptoms following treatment; 2 = significant improvement from pretreatment; 3 = patient somewhat improved; 4 = poor, symptoms identical or worse than pretreatment)
次要结局
未报告次要终点
研究者
Erdem Sahin
Medical Doctor
Kars Harakani State Hospital