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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings