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Clinical Trials/NCT06737445
NCT06737445
Completed
Not Applicable

Comparative Efficacy of Corticosteroid Injection, Extracorporeal Shock Wave Therapy, and Radiofrequency Ablation for Chronic Plantar Fasciitis: a Prospective Randomized Controlled Trial

Kars Harakani State Hospital1 site in 1 country49 target enrollmentApril 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Plantar Fasciitis
Sponsor
Kars Harakani State Hospital
Enrollment
49
Locations
1
Primary Endpoint
Visual Analog Scale (VAS) scores
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
February 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kars Harakani State Hospital
Responsible Party
Principal Investigator
Principal Investigator

Erdem Sahin

Medical Doctor

Kars Harakani State Hospital

Eligibility Criteria

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)
  • 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
  • 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

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) scores

Time Frame: 1st month. 3rd month, 6th month

Pain score (1 to 10 points)

Foot Function Index (FFI)

Time Frame: 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

Time Frame: 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)

Study Sites (1)

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