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

Not Applicable

• Conditions: Extracorporeal Shock Wave Therapy
• Interventions: Device: Extracorporeal Shock Wave Therapy

• Registration Number: NCT04989530
• Lead Sponsor: Baskent University Ankara Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07-01
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Last Update Submitted: 2021-07-26
• Study First Posted: 2021-08-04
• Last Update Posted: 2021-08-04
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low energy level of ESWT	Extracorporeal Shock Wave Therapy	-
medium energy level of ESWT	Extracorporeal Shock Wave Therapy	-
high energy level of ESWT	Extracorporeal Shock Wave Therapy	-

Primary Outcome Measures

Name	Time	Method
Foot Function index	1 months

Secondary Outcome Measures

Name	Time	Method
Plantar fasia thickness	1 months	Measurement of plantar fascia thickness with ultrasound

Trial Locations

Locations (1)

Baskent University Ankara Hospital; 🇹🇷 Ankara, Turkey