- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07463794
Comparison of Extracorporeal Shock Wave Therapy and Whole Body Vibration Therapy in Plantar Fasciitis
Plantar Fasiit Tedavisinde ESWT ve Tüm Vücut Vibrasyon Uygulamalarının Etkinliğinin Karşılaştırılması: Randomize, Prospektif, Tek Kör Çalışma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized, prospective, single-blind clinical trial was conducted to compare the effects of extracorporeal shock wave therapy (ESWT) and whole body vibration therapy in patients diagnosed with plantar fasciitis. A total of 60 patients aged between 18 and 65 years were included in the final analysis. Participants were randomly assigned into two groups.
The first group received extracorporeal shock wave therapy applied once weekly for a total of five sessions. The second group received whole body vibration therapy three times per week for five weeks. Both groups followed the same standardized home exercise program during the treatment period.
Clinical evaluations were performed at baseline, at the end of treatment, and at the ninth week. The primary outcome measure was functional status assessed using the Foot Function Index (FFI). Secondary outcome measures included pain intensity assessed by the Visual Analog Scale (VAS), the American Orthopaedic Foot and Ankle Society (AOFAS) score, and the Roles and Maudsley score.The aim of this study is to determine and compare the clinical effectiveness of ESWT and whole body vibration therapy in the management of plantar fasciitis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey (Türkiye), 34245
- Gaziosmanpaşa Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 65 years
- Clinically diagnosed plantar fasciitis
- Heel pain lasting at least 4 weeks
- Ability to understand the study procedures and provide written informed consent
Exclusion Criteria:
- History of inflammatory rheumatic diseases
- Previous foot or ankle surgery
- Major trauma to the foot or ankle
- Neurological or vascular disorders of the lower extremities
- Pregnancy or lactation
- Corticosteroid injection to the foot within the last 3 months
- Physical therapy, extracorporeal shock wave therapy, or whole body vibration therapy within the last 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Extracorporeal Shock Wave Therapy (ESWT)
Participants received extracorporeal shock wave therapy once weekly for five sessions.
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Extracorporeal shock wave therapy was applied once weekly for a total of five sessions to the affected heel.
|
|
Experimental: Whole Body Vibration Therapy
Participants received whole body vibration therapy three times per week for five weeks.
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Whole body vibration therapy was applied three times per week for five weeks using a vibration platform.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Foot Function Index (FFI)
Time Frame: Baseline, 5 weeks and 9 weeks
|
Foot Function Index (FFI), a self-reported questionnaire consisting of 23 items in three subscales (pain, disability, and activity limitation), with scores ranging from 0 to 100.
Higher scores indicate worse foot-related disability.
|
Baseline, 5 weeks and 9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: Baseline, 5 weeks and 9 weeks
|
Pain severity assessed using the Visual Analog Scale (VAS).Visual Analog Scale (VAS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain.
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Baseline, 5 weeks and 9 weeks
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American Orthopaedic Foot and Ankle Society Score (AOFAS)
Time Frame: Baseline, 5 weeks and 9 weeks
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American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score, ranging from 0 to 100, where higher scores indicate better function.
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Baseline, 5 weeks and 9 weeks
|
|
Roles and Maudsley Score
Time Frame: Baseline, 5 weeks and 9 weeks
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Clinical outcome assessed using the Roles and Maudsley score.Roles and Maudsley Score (RM score), a 4-point ordinal scale ranging from 1 (excellent) to 4 (poor).
Lower scores indicate better clinical outcome.
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Baseline, 5 weeks and 9 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Berrin Hüner, Gaziosmanpaşa Training and Research Hospital
Publications and helpful links
General Publications
- Gerdesmeyer L, Frey C, Vester J, et al. Radial extracorporeal shock wave therapy is safe and effective in the treatment of chronic plantar fasciitis. Journal of Rehabilitation Medicine. 2008;40(6):425-430. doi:10.2340/jrm.v55.12405.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMU-EC-945-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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