Piriformis SyndromeNCT07145554
f-ESWT vs Steroid Injection for Piriformis Syndrome
A study testing Focal extracorporeal schock wave therapy and Steroid Injection in people with Piriformis Syndrome, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare two treatment methods for piriformis syndrome, a condition that can cause pain in the buttock and leg. Adult patients with piriformis syndrome will take part in the trial. Participants will be randomly assigned to one of two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Piriformis Syndrome
- What is being tested?
- Focal extracorporeal schock wave therapy and Steroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 1 Mar 2026
- 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
- Patients with piriformis syndrome whose pain has persisted for three months or longer despite standard medical care and activity modifications.
Who cannot join
- Individuals with lumbar discopathy diagnosed by magnetic resonance imaging or electrodiagnostic study.
- Patients with coccyx pain.
- Individuals with mechanical or inflammatory disorders of the sacroiliac joint.
- Patients with pelvic region diseases.
- Pregnancy
- History of previous lumbar disc surgery.
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- History of lumbar epidural block within the last 6 months.
- History of malignancy.
- Patients with signs of acute inflammation at the treatment site.
- Individuals with a cardiac pacemaker.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness of Focal Extracorporeal Shock Wave Therapy and Steroid Injection in Piriformis Syndrome
This study aims to compare two treatment methods for piriformis syndrome, a condition that can cause pain in the buttock and leg. Adult patients with piriformis syndrome will take part in the trial. Participants will be randomly assigned to one of two groups. One group will receive focal extracorporeal shock wave therapy (f-ESWT), a non-invasive treatment that uses sound waves. The other group will receive a steroid injection, which is a common treatment used to reduce pain and inflammation. The goal of this study is to find out which treatment is more effective in improving symptoms of piriformis syndrome.
- Conditions
- Piriformis Syndrome
- Being tested
- Focal extracorporeal schock wave therapy, Steroid Injection
- Medical subject headings
- Piriformis Muscle Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal extracorporeal schock wave therapyOther
Participants in this group will receive a total of 5 sessions of focal extracorporeal shock wave therapy. Each session will deliver 1000 pulses per cm² to the affected piriformis muscle.
Steroid InjectionProcedure or surgery
Participants in this group will receive a single injection of corticosteroid into the piriformis muscle.
| Study group | Role | What they receive |
|---|---|---|
| Shock wave group | Experimental | Not described Receives: Other: Focal extracorporeal schock wave therapy |
| Injection group | Experimental | Not described Receives: Procedure: Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by Numeric Rating Scale (NRS)
Measured: Baseline, 1 week, 4 weeks, and 12 weeks post-treatment
Quality of life measured by SF-36 questionnaire
Measured: Baseline and 4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Oct 2025
- Primary completion1 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Piriformis SyndromeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hilal Busra Aycicek, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145554
- Sponsor's protocol ID
- GulhaneTRH
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Focal Extracorporeal Shock Wave Therapy and Steroid Injection in Piriformis Syndrome
- ClinicalTrials.gov ID
- NCT07145554
- Acronym / sponsor ID
- GulhaneTRH
- Conditions
- Piriformis Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 28 Aug 2025 (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.
This study aims to compare two treatment methods for piriformis syndrome, a condition that can cause pain in the buttock and leg. Adult patients with piriformis syndrome will take part in the trial. Participants will be randomly assigned to one of two groups. One group will receive focal extracorporeal shock wave therapy (f-ESWT), a non-invasive treatment that uses sound waves. The other group will receive a steroid injection, which is a common treatment used to reduce pain and inflammation. The goal of this study is to find out which treatment is more effective in improving symptoms of piriformis syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shock wave group | Experimental | Other: Focal extracorporeal schock wave therapy |
| Injection group | Experimental | Procedure: Steroid Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with piriformis syndrome whose pain has persisted for three months or longer despite standard medical care and activity modifications.
Key exclusion criteria (10 listed)
- Individuals with lumbar discopathy diagnosed by magnetic resonance imaging or electrodiagnostic study.
- Patients with coccyx pain.
- Individuals with mechanical or inflammatory disorders of the sacroiliac joint.
- Patients with pelvic region diseases.
- Pregnancy
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 |
|---|---|---|
| Focal extracorporeal schock wave therapyParticipants in this group will receive a total of 5 sessions of focal extracorporeal shock wave therapy. Each session will deliver 1000 pulses per cm² to the affected piriformis muscle. | Other | Shock wave group |
| Steroid InjectionParticipants in this group will receive a single injection of corticosteroid into the piriformis muscle. | Procedure or surgery | Injection group |
Primary outcome
Pain intensity measured by Numeric Rating Scale (NRS)
Time frame: Baseline, 1 week, 4 weeks, and 12 weeks post-treatment
Quality of life measured by SF-36 questionnaire
Time frame: Baseline and 4 weeks post-treatment
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 Apr 2026.
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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 Focal extracorporeal schock wave therapy and Steroid Injection in people with Piriformis Syndrome, run by Gulhane Training and Research Hospital 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 1 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 20 Apr 2026. 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?
Pain intensity measured by Numeric Rating Scale (NRS) (time frame: Baseline, 1 week, 4 weeks, and 12 weeks post-treatment). 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 20 Apr 2026.