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

Study Overview
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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.

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

Conditions
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Extracorporeal Shock Wave Therapy

Intervention / Treatment
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* Device: Extracorporeal Shock Wave Therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low energy level of ESWT<br> | Device: Extracorporeal Shock Wave Therapy<br>* different energy levels of ESWT<br>|
| Active Comparator: medium energy level of ESWT<br> | Device: Extracorporeal Shock Wave Therapy<br>* different energy levels of ESWT<br>|
| Active Comparator: high energy level of ESWT<br> | Device: Extracorporeal Shock Wave Therapy<br>* different energy levels of ESWT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal Shock Wave Therapy, ultrasonography, plantar fasiit