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

Primary Purpose

Extracorporeal Shock Wave Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Extracorporeal Shock Wave Therapy
Sponsored by
Baskent University Ankara Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extracorporeal Shock Wave Therapy focused on measuring Extracorporeal Shock Wave Therapy, ultrasonography, plantar fasiit

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baskent University Ankara HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Low energy level of ESWT

medium energy level of ESWT

high energy level of ESWT

Arm Description

Outcomes

Primary Outcome Measures

Foot Function index

Secondary Outcome Measures

Plantar fasia thickness
Measurement of plantar fascia thickness with ultrasound

Full Information

First Posted
July 26, 2021
Last Updated
July 26, 2021
Sponsor
Baskent University Ankara Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04989530
Brief Title
Comparison of Ultrasonographic and Clinical Features of Different Energy Levels Extracorporeal Shock Wave Therapy in Plantar Fasciitis
Official Title
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
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University Ankara Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extracorporeal Shock Wave Therapy
Keywords
Extracorporeal Shock Wave Therapy, ultrasonography, plantar fasiit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low energy level of ESWT
Arm Type
Active Comparator
Arm Title
medium energy level of ESWT
Arm Type
Active Comparator
Arm Title
high energy level of ESWT
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shock Wave Therapy
Intervention Description
different energy levels of ESWT
Primary Outcome Measure Information:
Title
Foot Function index
Time Frame
1 months
Secondary Outcome Measure Information:
Title
Plantar fasia thickness
Description
Measurement of plantar fascia thickness with ultrasound
Time Frame
1 months
Other Pre-specified Outcome Measures:
Title
visual analogue scale
Time Frame
1 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Baskent University Ankara Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Şükran Güzel
Phone
+903122036868
Email
sukranguzel@windowslive.com

12. IPD Sharing Statement

Learn more about this trial

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

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