Spur, HeelNCT06356064
Radial or Focus Extracorporeal Shock Wave Therapy in Epin Calcanei
A study testing Extracorporeal shock wave therapy in people with Spur, Heel, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of the study was to investigate the effectiveness of radial and focused ESWT treatment on pain, function, and size of the calcaneal spur in patients with a clinical and radiological diagnosis of epin calcanei. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Spur, Heel
- What is being tested?
- Extracorporeal shock wave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 15 Jan 2024
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of heel pain for at least four weeks,
- Receiving no medical treatment, injection, physical or surgical treatment for the last four weeks and
- Agreed to participate in the study.
Who cannot join
- History of fracture or surgery,
- Polyneuropathy,
- Rheumatological diseases,
- Coagulation disorders,
- Tumor,
- Thrombosis,
Show all 10Show fewer
- Soft tissue or bone infection,
- Pregnancy and lactation,
- Epilepsy,
- Presence of a pacemaker.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of The Effectiveness of Extracorporeal Shock Wave Therapy in Patients Diagnosed With Epin Calcanei: Comparison of Radial and Focus Applications
Objective: The aim of the study was to investigate the effectiveness of radial and focused ESWT treatment on pain, function, and size of the calcaneal spur in patients with a clinical and radiological diagnosis of epin calcanei.
Methods: A total of 112 patients aged between 18 and 95 years were randomly divided into two groups: group 1 received rESWT (2.4 bar 12 hz 2000 beats), and group 2 received fESWT (0.14 bar 14 hz 1000 beats) three times a week for three weeks. All patients were evaluated using the Visual Analog Scale (VAS)-pain and Foot Function Index (FFI) before and after the treatment, at 4 weeks and 12 weeks. Epin size was measured radiographically in the patients before and after the treatment at the 12-week follow-up.
- Conditions
- Spur, Heel
- Being tested
- 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.
Extracorporeal shock wave therapyDevice
Radİal ESWT and focus ESWT
| Study group | Role | What they receive |
|---|---|---|
| rESWT( Radial Extracorporeal shock wave therapy) | Experimental | rESWT(2.4 bar, 12 hz, 2000 beats), to painful calcaneal area, three sessions, once a week, for total of three weeks Receives: Device: Extracorporeal shock wave therapy |
| fESWT(Focused Extracorporeal shock wave therapy)) | Experimental | fESWT (0.14 bar, 14 hz, 1000 beats), to painful calcaneal area, three sessions, once a week, for total of three weeks Receives: Device: Extracorporeal shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
0 min , 10 is maximum pain score
Measured: Before and after treatment baseline, 4th week, 12 th week
Functional Foot Index
0 is no pain 10 is max pain, and 0 is no deficiency 10 is the maximum deficiency and 0 is no activity limitation 10 is the maximum activity limitation score.
Measured: Before and after treatment baseline, 4th week, 12 th week
Secondary outcomes (1)
Radiographic assesment, epin size
A decrease in the size of the epin is an indicator of recovery.
Measured: Before and after treatment baseline, 4th week, 12 th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start15 May 2023
- Primary completion15 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spur, HeelStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356064
- Sponsor's protocol ID
- E2-23-3834
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: participant data will not share
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of The Effectiveness of Extracorporeal Shock Wave Therapy in Patients Diagnosed With Epin Calcanei: Comparison of Radial and Focus Applications
- ClinicalTrials.gov ID
- NCT06356064
- Acronym / sponsor ID
- E2-23-3834
- Conditions
- Spur, Heel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 10 Apr 2024 (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.
Objective: The aim of the study was to investigate the effectiveness of radial and focused ESWT treatment on pain, function, and size of the calcaneal spur in patients with a clinical and radiological diagnosis of epin calcanei.
Methods: A total of 112 patients aged between 18 and 95 years were randomly divided into two groups: group 1 received rESWT (2.4 bar 12 hz 2000 beats), and group 2 received fESWT (0.14 bar 14 hz 1000 beats) three times a week for three weeks. All patients were evaluated using the Visual Analog Scale (VAS)-pain and Foot Function Index (FFI) before and after the treatment, at 4 weeks and 12 weeks. Epin size was measured radiographically in the patients before and after the treatment at the 12-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rESWT( Radial Extracorporeal shock wave therapy) | Experimental | Device: Extracorporeal shock wave therapyrESWT(2.4 bar, 12 hz, 2000 beats), to painful calcaneal area, three sessions, once a week, for total of three weeks |
| fESWT(Focused Extracorporeal shock wave therapy)) | Experimental | Device: Extracorporeal shock wave therapyfESWT (0.14 bar, 14 hz, 1000 beats), to painful calcaneal area, three sessions, once a week, for total of three weeks |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of heel pain for at least four weeks,
- Receiving no medical treatment, injection, physical or surgical treatment for the last four weeks and
- Agreed to participate in the study.
Key exclusion criteria (10 listed)
- History of fracture or surgery,
- Polyneuropathy,
- Rheumatological diseases,
- Coagulation disorders,
- Tumor,
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 |
|---|---|---|
| Extracorporeal shock wave therapyRadİal ESWT and focus ESWT | Device | fESWT(Focused Extracorporeal shock wave therapy)), rESWT( Radial Extracorporeal shock wave therapy) |
Primary outcome
Visual Analog Scale
Time frame: Before and after treatment baseline, 4th week, 12 th week
0 min , 10 is maximum pain score
Functional Foot Index
Time frame: Before and after treatment baseline, 4th week, 12 th week
0 is no pain 10 is max pain, and 0 is no deficiency 10 is the maximum deficiency and 0 is no activity limitation 10 is the maximum activity limitation score.
1 secondary outcome
Radiographic assesment, epin size
Time frame: Before and after treatment baseline, 4th week, 12 th week
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 22 Apr 2024.
- Individual participant dataSharing planned: No. participant data will not share
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave therapy in people with Spur, Heel, run by Ankara City Hospital Bilkent 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 10 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 22 Apr 2024. 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. 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 Analog Scale (time frame: Before and after treatment baseline, 4th week, 12 th week). The study lists 2 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 22 Apr 2024.