Comparation of Radial and Focused Extracorporeal Shock Waves in Calcaneal Spur: A Randomised Sham-controlled Trial
Comparative Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Calcaneal Spur: A Randomised Sham-controlled Trial
1 other identifier
interventional
92
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2020
CompletedFirst Submitted
Initial submission to the registry
April 6, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedJanuary 20, 2022
January 1, 2022
8 months
April 6, 2021
January 4, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Visual Analogue Scale
pain evaluation, higher scores mean a worse outcome.
1 min.
American Orthopedic Foot and Ankle Score
higher scores mean a better outcome.
5 min.
FOOT FUNCTION INDEX
higher scores mean a worse outcome.
7 min.
Study Arms (3)
Focus extracorporeal shock wave therapy
ACTIVE COMPARATORRadial extracorporeal shock wave therapy
ACTIVE COMPARATORSham extracorporeal shock wave therapy
SHAM COMPARATORInterventions
Focus extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
Radial extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
Sham extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
Eligibility Criteria
You may qualify if:
- Clinical and radiological diagnosis of plantar calcaneal spur
- be aged ≥18 at the time of diagnosis
- be give informed consent
You may not qualify if:
- have not completed the assessment process.
- foot deformity
- psychological disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yuzuncu Yil University
Van, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Şeyhmus Kaplan
Yuzuncu Yil University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 6, 2021
First Posted
April 8, 2021
Study Start
August 7, 2019
Primary Completion
April 10, 2020
Study Completion
April 10, 2020
Last Updated
January 20, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share