Back to resultsComparation of Radial and Focused Extracorporeal Shock Waves in Calcaneal Spur: A Randomised Sham-controlled Trial
Primary Purpose
Calcaneal Spur
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Focus extracorporeal shock wave therapy
Radial extracorporeal shock wave therapy
Sham extracorporeal shock wave therapy
Sponsored by
About this trial
This is an interventional treatment trial for Calcaneal Spur
Eligibility Criteria
Inclusion Criteria:
- Clinical and radiological diagnosis of plantar calcaneal spur
- be aged ≥18 at the time of diagnosis
- be give informed consent
Exclusion Criteria:
- have not completed the assessment process.
- foot deformity
- psychological disease
Sites / Locations
- Yuzuncu Yil University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Focus extracorporeal shock wave therapy
Radial extracorporeal shock wave therapy
Sham extracorporeal shock wave therapy
Arm Description
Outcomes
Primary Outcome Measures
Visual Analogue Scale
pain evaluation, higher scores mean a worse outcome.
American Orthopedic Foot and Ankle Score
higher scores mean a better outcome.
FOOT FUNCTION INDEX
higher scores mean a worse outcome.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04836845
Brief Title
Comparation of Radial and Focused Extracorporeal Shock Waves in Calcaneal Spur: A Randomised Sham-controlled Trial
Official Title
Comparative Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Calcaneal Spur: A Randomised Sham-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 7, 2019 (Actual)
Primary Completion Date
April 10, 2020 (Actual)
Study Completion Date
April 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To date, focused and radial types of ESWT have been effectively used in calcaneal spur. However, studies directly addressing a comparison between radial and focused types of ESWT in calcaneal spur have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused ESWT options on calcaneal spur.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcaneal Spur
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Focus extracorporeal shock wave therapy
Arm Type
Active Comparator
Arm Title
Radial extracorporeal shock wave therapy
Arm Type
Active Comparator
Arm Title
Sham extracorporeal shock wave therapy
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Focus extracorporeal shock wave therapy
Intervention Description
Focus extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
Intervention Type
Device
Intervention Name(s)
Radial extracorporeal shock wave therapy
Intervention Description
Radial extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
Intervention Type
Device
Intervention Name(s)
Sham extracorporeal shock wave therapy
Intervention Description
Sham extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
pain evaluation, higher scores mean a worse outcome.
Time Frame
1 min.
Title
American Orthopedic Foot and Ankle Score
Description
higher scores mean a better outcome.
Time Frame
5 min.
Title
FOOT FUNCTION INDEX
Description
higher scores mean a worse outcome.
Time Frame
7 min.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical and radiological diagnosis of plantar calcaneal spur
be aged ≥18 at the time of diagnosis
be give informed consent
Exclusion Criteria:
have not completed the assessment process.
foot deformity
psychological disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şeyhmus Kaplan
Organizational Affiliation
Yuzuncu Yıl University
Official's Role
Study Director
Facility Information:
Facility Name
Yuzuncu Yil University
City
Van
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparation of Radial and Focused Extracorporeal Shock Waves in Calcaneal Spur: A Randomised Sham-controlled Trial
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