Calcaneal SpurNCT04836845
Comparation of Radial and Focused Extracorporeal Shock Waves in Calcaneal Spur: A Randomised Sham-controlled Trial
A study testing Focus extracorporeal shock wave therapy and Radial extracorporeal shock wave therapy in people with Calcaneal Spur, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcaneal Spur
- What is being tested?
- Focus extracorporeal shock wave therapy and Radial extracorporeal shock wave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Aug 2019to 10 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and radiological diagnosis of plantar calcaneal spur
- be aged ≥18 at the time of diagnosis
- be give informed consent
Who cannot join
- have not completed the assessment process.
- foot deformity
- psychological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Calcaneal Spur: A Randomised Sham-controlled Trial
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.
- Conditions
- Calcaneal Spur
- Being tested
- Focus extracorporeal shock wave therapy, Radial extracorporeal shock wave therapy, Sham extracorporeal shock wave therapy
- Medical subject headings
- Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus extracorporeal shock wave therapyDevice
Focus extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
Radial extracorporeal shock wave therapyDevice
Radial extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
Sham extracorporeal shock wave therapyDevice
Sham extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
| Study group | Role | What they receive |
|---|---|---|
| Focus extracorporeal shock wave therapy | Active comparator | Not described Receives: Device: Focus extracorporeal shock wave therapy |
| Radial extracorporeal shock wave therapy | Active comparator | Not described Receives: Device: Radial extracorporeal shock wave therapy |
| Sham extracorporeal shock wave therapy | Sham comparator | Not described Receives: Device: Sham extracorporeal shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
pain evaluation, higher scores mean a worse outcome.
Measured: 1 min.
American Orthopedic Foot and Ankle Score
higher scores mean a better outcome.
Measured: 5 min.
FOOT FUNCTION INDEX
higher scores mean a worse outcome.
Measured: 7 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start7 Aug 2019
- Primary completion10 Apr 2020
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcaneal SpurStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Şah, Yuzuncu Yil University
- Investigators
- Şeyhmus Kaplan, Study director, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836845
- Sponsor's protocol ID
- Yuzuncu Yil University Van
- Status last verified
- Jan 2022
- First submitted
- 6 Apr 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Calcaneal Spur: A Randomised Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT04836845
- Acronym / sponsor ID
- Yuzuncu Yil University Van
- Conditions
- Calcaneal Spur
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Focus extracorporeal shock wave therapy | Active comparator | Device: Focus extracorporeal shock wave therapy |
| Radial extracorporeal shock wave therapy | Active comparator | Device: Radial extracorporeal shock wave therapy |
| Sham extracorporeal shock wave therapy | Sham comparator | Device: Sham extracorporeal shock wave therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical and radiological diagnosis of plantar calcaneal spur
- be aged ≥18 at the time of diagnosis
- be give informed consent
Key exclusion criteria (3 listed)
- have not completed the assessment process.
- foot deformity
- psychological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus extracorporeal shock wave therapyFocus extracorporeal shock wave therapy, device: Electronica, Pagani, Italy | Device | Focus extracorporeal shock wave therapy |
| Radial extracorporeal shock wave therapyRadial extracorporeal shock wave therapy, device: Electronica, Pagani, Italy | Device | Radial extracorporeal shock wave therapy |
| Sham extracorporeal shock wave therapySham extracorporeal shock wave therapy, device: Electronica, Pagani, Italy | Device | Sham extracorporeal shock wave therapy |
Primary outcome
Visual Analogue Scale
Time frame: 1 min.
pain evaluation, higher scores mean a worse outcome.
American Orthopedic Foot and Ankle Score
Time frame: 5 min.
higher scores mean a better outcome.
FOOT FUNCTION INDEX
Time frame: 7 min.
higher scores mean a worse outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şeyhmus Kaplan study director
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus extracorporeal shock wave therapy and Radial extracorporeal shock wave therapy in people with Calcaneal Spur, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 1 min.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.