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

Overview

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.

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Investigator)
• Study Primary Completion Date: September 1, 2021

Interventions

• Device: Extracorporeal Shock Wave Therapy
  • different energy levels of ESWT

Arms, Groups and Cohorts

• Active Comparator: Low energy level of ESWT
• Active Comparator: medium energy level of ESWT
• Active Comparator: high energy level of ESWT

Clinical Trial Outcome Measures

Primary Measures

• Foot Function index
  • Time Frame: 1 months

Secondary Measures

• Plantar fasia thickness
  • Time Frame: 1 months
  • Measurement of plantar fascia thickness with ultrasound

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Baskent University Ankara Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Şükran Güzel, M.D. – Baskent University Ankara Hospital