Comparative Efficacy of Corticosteroid Injection, Extracorporeal Shock Wave Therapy, and Radiofrequency Ablation for Chronic Plantar Fasciitis: A Prospective Randomized Controlled Trial
| Registry | NCT06737445 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 49 (Actual) |
| Sponsor | Kars Harakani State Hospital (Other) |
| Conditions | Chronic Plantar Fasciitis |
| Interventions | Radiofrequency ablation alone, Cortisone Injection, Extracorporeal shock wave therapy (Procedure, other) |
| Dates | start 2021-04-01, primary completion 2023-02-01, completion 2023-02-01, first posted 2024-12-17, last updated 2024-12-19 |
| Locations | 1 site in Turkey (Türkiye) |
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All trials for Chronic Plantar Fasciitis All trials of Radiofrequency ablation alone All trials of Cortisone Injection
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Radiofrequency thermal lesioning (RTL) | Active comparator | Procedure: Radiofrequency ablation alone | RTL was performed as a single session using the radiofrequency ablation device (NeuroTherm JK4A; NeuroTherm Ltd, Croydon, London, England). |
| Extracorporeal shock wave therapy (ESWT) | Active comparator | Other: Extracorporeal shock wave therapy | Patients underwent 3 ESWT sessions applied to the plantar heel area, once a week with the same ESWT dose (15 Hz, 2000 pulse, 4.0 bar energy density) using a BTL-5000 SWT device (BTL Industries, USA). |
| Corticosteroid Injection | Active comparator | Procedure: Cortisone Injection | An injection of 1 ml of betamethasone 40 mg/ml and 2 ml of bupivacaine 5 mg/ml was performed. |
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria: * 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) * Age ≥ 18 * BMI ≤ 35 * VAS ≥ 5 following the first step in the morning or after periods of prolonged inactivity * Willingness to participate in the study Exclusion Criteria: * 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 * BMI >35 * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Kars Harakani State Hospital | Kars, Merkez | Turkey (Türkiye) |