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CompletedNCT04836845Updated Jan 20, 2022

Comparation of Radial and Focused Extracorporeal Shock Waves in Calcaneal Spur: A Randomised Sham-controlled Trial

An interventional study of Focus extracorporeal shock wave therapy and Radial extracorporeal shock wave therapy in Calcaneal Spur, sponsored by Yuzuncu Yil University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-20.

Sponsored by Yuzuncu Yil University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Aug 2019, registered Apr 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Calcaneal Spur

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03

In context

Heel Spur

28 studies on the registry are indexed under Heel Spur; 8 are open to participants now.

This study's enrollment of 92 is above the median of 60 across 22 interventional studies indexed under Heel Spur.

Browse Heel Spur studies →

Lead sponsor

Yuzuncu Yil University is the lead sponsor of 78 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical and radiological diagnosis of plantar calcaneal spur
  • be aged ≥18 at the time of diagnosis
  • be give informed consent

Exclusion criteria

Exclusion Criteria:

  • have not completed the assessment process.
  • foot deformity
  • psychological disease
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
92 participants (actual)

Study arms

  • Active comparator
    Focus extracorporeal shock wave therapy

    Device: Focus extracorporeal shock wave therapy

  • Active comparator
    Radial extracorporeal shock wave therapy

    Device: Radial extracorporeal shock wave therapy

  • Sham comparator
    Sham extracorporeal shock wave therapy

    Device: Sham extracorporeal shock wave therapy

Interventions

  • DeviceFocus extracorporeal shock wave therapy

    Focus extracorporeal shock wave therapy, device: Electronica, Pagani, Italy

  • DeviceRadial extracorporeal shock wave therapy

    Radial extracorporeal shock wave therapy, device: Electronica, Pagani, Italy

  • DeviceSham extracorporeal shock wave therapy

    Sham extracorporeal shock wave therapy, device: Electronica, Pagani, Italy

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale

    pain evaluation, higher scores mean a worse outcome.

    Time frame: 1 min.

  2. American Orthopedic Foot and Ankle Score

    higher scores mean a better outcome.

    Time frame: 5 min.

  3. FOOT FUNCTION INDEX

    higher scores mean a worse outcome.

    Time frame: 7 min.

07

Study locations

1 site
  • Yuzuncu Yil University
    Van, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2019 to primary completion in Apr 2020, 8 months.

Of 17 interventional studies with no phase under Heel Spur, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 15. This study's 8 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 6, 2021
First posted
Apr 8, 2021
StartActual
Aug 7, 2019
Primary completionActual
Apr 10, 2020
CompletionActual
Apr 10, 2020
Last update
Jan 20, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04836845
Lead sponsor
Yuzuncu Yil University
Responsible party
Volkan Şah (Principal Investigator, Yuzuncu Yil University) — Principal investigator
First posted
Apr 8, 2021
Start date
Aug 7, 2019
Primary completion
Apr 10, 2020
Completion
Apr 10, 2020
Last update
Jan 20, 2022

Study contacts

Şeyhmus Kaplan
study director · Yuzuncu Yil University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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