Radial or Focus Extracorporeal Shock Wave Therapy in Epin Calcanei

April 18, 2024 updated by: Ankara City Hospital Bilkent

Investigation of The Effectiveness of Extracorporeal Shock Wave Therapy in Patients Diagnosed With Epin Calcanei: Comparison of Radial and Focus Applications

Objective: The aim of the study was to investigate the effectiveness of radial and focused ESWT treatment on pain, function, and size of the calcaneal spur in patients with a clinical and radiological diagnosis of epin calcanei.

Methods: A total of 112 patients aged between 18 and 95 years were randomly divided into two groups: group 1 received rESWT (2.4 bar 12 hz 2000 beats), and group 2 received fESWT (0.14 bar 14 hz 1000 beats) three times a week for three weeks. All patients were evaluated using the Visual Analog Scale (VAS)-pain and Foot Function Index (FFI) before and after the treatment, at 4 weeks and 12 weeks. Epin size was measured radiographically in the patients before and after the treatment at the 12-week follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

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
      • Ankara, Turkey
        • Özge TEZEN

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;

  • Presence of heel pain for at least four weeks,
  • Receiving no medical treatment, injection, physical or surgical treatment for the last four weeks and
  • Agreed to participate in the study.

Exclusion Criteria:

  • History of fracture or surgery,
  • Polyneuropathy,
  • Rheumatological diseases,
  • Coagulation disorders,
  • Tumor,
  • Thrombosis,
  • Soft tissue or bone infection,
  • Pregnancy and lactation,
  • Epilepsy,
  • Presence of a pacemaker.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rESWT( Radial Extracorporeal shock wave therapy)
rESWT(2.4 bar, 12 hz, 2000 beats), to painful calcaneal area, three sessions, once a week, for total of three weeks
Device: Extracorporeal shock wave therapy
Radİal ESWT and focus ESWT
Experimental: fESWT(Focused Extracorporeal shock wave therapy))
fESWT (0.14 bar, 14 hz, 1000 beats), to painful calcaneal area, three sessions, once a week, for total of three weeks
Device: Extracorporeal shock wave therapy
Radİal ESWT and focus ESWT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Before and after treatment baseline, 4th week, 12 th week
0 min , 10 is maximum pain score
Before and after treatment baseline, 4th week, 12 th week
Functional Foot Index
Time Frame: Before and after treatment baseline, 4th week, 12 th week
0 is no pain 10 is max pain, and 0 is no deficiency 10 is the maximum deficiency and 0 is no activity limitation 10 is the maximum activity limitation score.
Before and after treatment baseline, 4th week, 12 th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic assesment, epin size
Time Frame: Before and after treatment baseline, 4th week, 12 th week
A decrease in the size of the epin is an indicator of recovery.
Before and after treatment baseline, 4th week, 12 th week

Collaborators and Investigators

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

Sponsor

Ankara City Hospital Bilkent

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)

May 15, 2023

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

January 15, 2024

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2-23-3834

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

participant data will not share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Spur, Heel

Clinical Trials on Extracorporeal shock wave therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe