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

NCT ID: NCT04989530

Last Updated: 2021-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-09-01

Brief Summary

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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

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Conditions

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Extracorporeal Shock Wave Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low energy level of ESWT

Group Type ACTIVE_COMPARATOR

Extracorporeal Shock Wave Therapy

Intervention Type DEVICE

different energy levels of ESWT

medium energy level of ESWT

Group Type ACTIVE_COMPARATOR

Extracorporeal Shock Wave Therapy

Intervention Type DEVICE

different energy levels of ESWT

high energy level of ESWT

Group Type ACTIVE_COMPARATOR

Extracorporeal Shock Wave Therapy

Intervention Type DEVICE

different energy levels of ESWT

Interventions

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Extracorporeal Shock Wave Therapy

different energy levels of ESWT

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baskent University Ankara Hospital

OTHER

Sponsor Role lead

Responsible Party

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Şükran Güzel

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Baskent University Ankara Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Şükran Güzel

Role: primary

+903122036868

Other Identifiers

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E-94603339-604.01.02-46403

Identifier Type: -

Identifier Source: org_study_id

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