Comparison of the Acute Effects of Focused and Radial ESWT on Pain and Balance Performance in Individuals With Plantar Fasciitis: A Randomized Clinical Trial (ESWT)

November 11, 2024 updated by: Tuğba Kocahan, Gulhane Training and Research Hospital
This study aimed to compare the acute effects of focused and radial ESWT on pain and balance performance in individuals with plantar fasciitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aimed to compare the acute effects of focused and radial ESWT on pain and balance performance in individuals with plantar fasciitis. The study included 40 individuals (27 females and 13 males) aged between 18 and 63 years, presenting with plantar fasciitis (PF). Extracorporeal shockwave therapy (ESWT) was administered once a week for four weeks. The participants were randomly assigned to two groups (f-ESWT and r-ESWT). Pain levels were assessed using the Visual Analogue Scale, while Static and Dynamic Balance were evaluated using the Biodex Balance System.

Study Type

Interventional

Enrollment (Actual)

40

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, 06018
        • University of Health Sciences, Gulhane Faculty of Medicine

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

unilateral or bilateral tenderness in the medial tubercle of calcaneus and heel pain in the first few steps in the morning, which gets worse with increased activity, absence of any known systemic disease, absence of any surgical procedure to lower extremity, absence of any treatment for PF in the last 6 months, 18-65 years, and consent to participate in the study.

Exclusion Criteria:

pregnancy, pacemaker, receiving anticoagulant therapy, uncontrolled cardiovascular disease, tumor, acute infection, nerve root compression, local dermatological or neurological problems, diabetes mellitus, taking anti-inflammatory drugs during treatment, or incomplete follow-up.

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: f-ESWT Group
Twenty patients with plantar fasciitis received f-ESWT treatment once a week for four weeks.
Other: f-ESWT
In the f-ESWT group, a total of 8 Hz, 0.28 mJ/mm2, and 2000 pulses were applied while in the r-ESWT group, a total of 8 Hz, 1.8 bar, and 2000 pulses were applied
Active Comparator: r-ESWT Group
Twenty patients with plantar fasciitis received r-ESWT treatment once a week for four weeks.
Other: r-ESWT
In the f-ESWT group, a total of 8 Hz, 0.28 mJ/mm2, and 2000 pulses were applied while in the r-ESWT group, a total of 8 Hz, 1.8 bar, and 2000 pulses were applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) was used to determine the intensity of pain in patients with PF, and Biodex Balance System device (Biodex Balance System SD, 2009 USA) was used to assess balance performance.
Time Frame: Baseline and 5 weeks
The Visual Analogue Scale (VAS) was employed to ascertain the intensity of pain experienced by the affected/more affected extremities. The Biodex Balance System device (Biodex Balance System SD, 2009 USA) was used to assess balance performance.
Baseline and 5 weeks

Collaborators and Investigators

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

Sponsor

Gulhane Training and Research Hospital

Investigators

  • Study Chair: Aydan Örsçelik, Associate Professor MD, Health Sciences University, Gulhane Training and Research Hospital

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)

December 15, 2023

Primary Completion (Actual)

July 15, 2024

Study Completion (Actual)

August 15, 2024

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Estimated)

November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/285
  • Health Sciences University (Gülhane Training and Research Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data can be shared after publication as an article

IPD Sharing Time Frame

Once published as an article, data can be shared for one year

IPD Sharing Access Criteria

After the article is published, it can be requested from the responsible researcher upon request.

IPD Sharing Supporting Information Type

  • SAP

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.

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