Comparison of Ultrasonographic and Clinical Features of Different Energy Levels Extracorporeal Shock Wave Therapy in Plantar Fasciitis

Comparison of Ultrasonographic and Clinical Features of Different Energy Levels Extracorporeal Shock Wave Therapy in Plantar Fasciitis: A Randomized, Prospective, Double-blind Clinical Trial

Plantar fasciitis is the most common cause of heel pain in adults. It received FDA approval in 2000 for ESWT in the treatment of plantar fasciitis in adults whose pain did not resolve with conservative treatment.

ESWT energy levels are categorized as high, medium and low. It is not yet clear which energy level is most effective in the clinical recovery and pain relief of plantar fasciitis after ESWT treatment. Although there are studies in the literature evaluating the effect of different energy densities in the treatment of plantar fasciitis with ESWT, there are very few studies comparing different treatment doses of ESWT.

The aim of this study was to evaluate and compare the therapeutic effects of low, medium and high energy ESWT in patients with plantar fasciitis, and also to examine the correlation between plantar fascia thickness changes ultrasonographically and clinical outcomes.

Study Overview

• Status: Recruiting
• Conditions: Extracorporeal Shock Wave Therapy
• Intervention / Treatment: Device: Extracorporeal Shock Wave Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Baskent University Ankara Hospital
    • Contact: Şükran Güzel; Phone Number: +903122036868; Email: sukranguzel@windowslive.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

presence of heel pain, tenderness at the insertion site of the plantar fascia on the anteromedial aspect of the calcaneal tubercle elicited by palpation, and unresponsiveness to medical treatment.

Exclusion Criteria:

history of inflammatory rheumatic disease, trauma of the foot or foot surgery, local dermatological lesion or infection, impaired peripheral circulation, a neurological disorder such as radiculopathy and neuropathy, patients with sequelae of lower extremity fracture, a congenital or acquired deformity, malignancy, cardiac pacemaker, metal implant at the application site, pregnancy, anticoagulant use for coagulopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low energy level of ESWT	Device: Extracorporeal Shock Wave Therapy; different energy levels of ESWT
Active Comparator: medium energy level of ESWT	Device: Extracorporeal Shock Wave Therapy; different energy levels of ESWT
Active Comparator: high energy level of ESWT	Device: Extracorporeal Shock Wave Therapy; different energy levels of ESWT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Foot Function index	1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plantar fasia thickness	Measurement of plantar fascia thickness with ultrasound	1 months

Other Outcome Measures

Outcome Measure	Time Frame
visual analogue scale	1 months

Collaborators and Investigators

• Sponsor: Baskent University Ankara Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: ultrasonography; Extracorporeal Shock Wave Therapy; plantar fasiit
• Additional Relevant MeSH Terms: Pathologic Processes; Foot Diseases; Musculoskeletal Diseases; Shock; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: E-94603339-604.01.02-46403

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