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

December 16, 2024 updated by: Erdem Sahin, Kars Harakani State Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Kars, Merkez, Turkey, 36000
        • Kars Harakani State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Radiofrequency thermal lesioning (RTL)
RTL was performed as a single session using the radiofrequency ablation device (NeuroTherm JK4A; NeuroTherm Ltd, Croydon, London, England).
Procedure: Radiofrequency ablation alone
RTL was performed as a single session using the radiofrequency ablation device (NeuroTherm JK4A; NeuroTherm Ltd, Croydon, London, England).
Active Comparator: Extracorporeal shock wave therapy (ESWT)
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).
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).
Active Comparator: Corticosteroid Injection
An injection of 1 ml of betamethasone 40 mg/ml and 2 ml of bupivacaine 5 mg/ml was performed.
Procedure: Cortisone Injection
An injection of 1 ml of betamethasone 40 mg/ml and 2 ml of bupivacaine 5 mg/ml was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) scores
Time Frame: 1st month. 3rd month, 6th month
Pain score (1 to 10 points)
1st month. 3rd month, 6th month
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.)
1st month. 3rd month, 6th month,
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)
1st month. 3rd month, 6th month,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kars Harakani State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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