Corticosteroid Injection, Extracorporeal Shock Wave Therapy, and Radiofrequency Ablation for Chronic Plantar Fasciitis:

Not Applicable

Completed

• Conditions: Chronic Plantar Fasciitis

• Registration Number: NCT06737445
• Lead Sponsor: Kars Harakani State Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) scores	1st month. 3rd month, 6th month	Pain score (1 to 10 points)
Foot Function Index (FFI)	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	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)

Trial Locations

Locations (1)

Kars Harakani State Hospital; 🇹🇷 Kars, Merkez, Turkey