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

NCT06685172 | Completed

• 2 other identifiers: 2023/285Health Sciences University
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the acute effects of focused and radial ESWT on pain and balance performance in individuals with plantar fasciitis.

Conditions

Plantar Fascitis; Pain

Keywords

Balance; pain; plantar fasciitis; stability

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (2)

f-ESWT Group

ACTIVE COMPARATOR

Twenty patients with plantar fasciitis received f-ESWT treatment once a week for four weeks.

Other: f-ESWT

r-ESWT Group

ACTIVE COMPARATOR

Twenty patients with plantar fasciitis received r-ESWT treatment once a week for four weeks.

Other: r-ESWT

Interventions

f-ESWT OTHER

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

f-ESWT Group

r-ESWT OTHER

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

r-ESWT Group

Eligibility Criteria

• Age: 18 Months - 63 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gulhane Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences, Gulhane Faculty of Medicine

Ankara, 06018, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Aydan Örsçelik, Associate Professor MD

  Health Sciences University, Gulhane Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor MD

Model Details: A total of 40 patients with plantar fasciitis were randomly assigned to focal-ESWT treatment (n= 20) or radial-ESWT treatment (n= 20).

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: December 15, 2023
• Primary Completion: July 15, 2024
• Study Completion: August 15, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Once published as an article, data can be shared for one year
• Access Criteria: After the article is published, it can be requested from the responsible researcher upon request.

Locations

TU (1)