Piriformis SyndromeNCT07473349
Diagnostic Accuracy of Clinical Tests and Diagnostic Criteria for Piriformis Syndrome
A study testing Ultrasound-Guided Piriformis Injection in people with Piriformis Syndrome and Gluteal Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Piriformis syndrome is a clinical condition characterized by buttock pain and/or sciatic-like symptoms, and its diagnosis remains challenging because there is no universally accepted diagnostic standard. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Piriformis Syndrome, Gluteal Pain
- What is being tested?
- Ultrasound-Guided Piriformis Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75 years
- Presentation with gluteal pain
- Pain on palpation in the piriformis region
Who cannot join
- History of injection to the lumbar, hip, or gluteal region within the last 3 months,including steroid, hyaluronic acid, or similar injections
- History of hip surgery
- Presence of active inflammatory rheumatic disease, including rheumatoid arthritis, ankylosing spondylitis, polymyalgia rheumatica, vasculitis, or similar conditions
- Active skin or subcutaneous soft tissue infection in the gluteal region
- Use of anticoagulant therapy that may contraindicate injection
- Presence of a bleeding disorder
Show all 12Show fewer
- Uncontrolled diabetes mellitus and/or hypertension
- History of neurological disease
- Pregnancy or lactation
- Presence of a psychiatric disorder
- Known allergy to the injection agents
- History of malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
Istanbul
Busra Nur Aslantas, MD, +905075985562, busra.kaya1@iuc.edu.tr
About this study
Official title: Evaluation of the Diagnostic Accuracy of Diagnostic Criteria and Clinical Tests for Piriformis Syndrome
Piriformis syndrome is a clinical condition characterized by buttock pain and/or sciatic-like symptoms, and its diagnosis remains challenging because there is no universally accepted diagnostic standard. This study aims to evaluate the diagnostic accuracy of commonly used diagnostic criteria and clinical tests for piriformis syndrome. Participants with suspected piriformis syndrome will undergo standardized physical examination and assessment of predefined diagnostic criteria. Ultrasound-guided injection of 5 mL of 2% lidocaine into the piriformis muscle will be used as the reference diagnostic procedure. A reduction of 50% or more in pain after injection will be considered confirmation of piriformis syndrome. The diagnostic performance of clinical tests and diagnostic criteria will be analyzed accordingly.
Read the detailed description
Piriformis syndrome is one of the possible causes of buttock pain and sciatica-like symptoms; however, its diagnosis is often difficult because of symptom overlap with lumbar radiculopathy, sacroiliac joint disorders, and other musculoskeletal conditions. In clinical practice, several physical examination maneuvers and diagnostic criteria are used, but their diagnostic accuracy has not been sufficiently established.
The aim of this study is to evaluate the diagnostic accuracy of predefined diagnostic criteria and commonly used clinical tests for piriformis syndrome. Adult participants with suspected piriformis syndrome will be recruited prospectively. All participants will undergo a standardized clinical assessment including history taking, physical examination, and evaluation of predefined diagnostic criteria and provocation tests. Clinical examinations will be performed by two physicians according to the study protocol.
As the reference diagnostic procedure, participants will undergo ultrasound-guided injection of 5 mL of 2% lidocaine into the piriformis muscle. The injection will be performed by an experienced physician under ultrasound guidance. Pain severity will be assessed before and after the procedure. A decrease of 50% or more in pain following injection will be accepted as confirmation of piriformis syndrome.
The diagnostic performance of each clinical test and diagnostic criterion set will be evaluated against this reference standard. Sensitivity, specificity, predictive values, likelihood ratios, and overall diagnostic accuracy will be analyzed. The findings of this study are expected to contribute to the development of a more standardized, reliable, and clinically applicable diagnostic approach for piriformis syndrome.
- Conditions
- Piriformis Syndrome, Gluteal Pain
- Being tested
- Ultrasound-Guided Piriformis Injection
- Keywords
- Ultrasound-Guided Injection, Piriformis Syndrome, Gluteal Pain, Sciatica, Diagnostic Accuracy, Clinical Tests, Diagnostic Criteria
- Medical subject headings
- Piriformis Muscle Syndrome, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Piriformis InjectionDiagnostic test
Ultrasound-guided injection of 5 mL of 2% lidocaine into the piriformis muscle for diagnostic confirmation. A patient-reported pain reduction of 50% or more at 1 hour after injection will be considered confirmation of piriformis syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Participants With Suspected Piriformis Syndrome | Experimental | Participants with suspected piriformis syndrome will undergo standardized clinical assessment and the diagnostic intervention defined as Ultrasound-Guided Piriformis Injection, consisting of ultrasound-guided injection of 5 mL of 2% lidocaine into the piriformis muscle. Receives: Diagnostic Test: Ultrasound-Guided Piriformis Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of clinical tests and diagnostic criteria for piriformis syndrome
Diagnostic accuracy of predefined clinical tests and diagnostic criteria will be evaluated using pain response to ultrasound-guided piriformis injection as the reference standard. A positive reference standard result will be defined as a patient-reported reduction of 50% or more in pain at 1 hour after injection compared with pre-injection pain. Participants with a positive reference standard result will be classified as having piriformis syndrome for the diagnostic accuracy analysis.
Measured: Same day; pain response assessed 1 hour after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Piriformis SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo the same standardized diagnostic protocol, including clinical examination, assessment of predefined diagnostic criteria, and ultrasound-guided injection of 5 mL of 2% lidocaine into the piriformis muscle. Diagnostic accuracy will be evaluated in a single-group design.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Nur Aslantas, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473349
- Sponsor's protocol ID
- CTFPIR2025
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data has not yet been determined.
Publications
Misirlioglu TO, Akgun K, Palamar D, Erden MG, Erbilir T. Piriformis syndrome: comparison of the effectiveness of local anesthetic and corticosteroid injections: a double-blinded, randomized controlled study. Pain Physician. 2015 Mar-Apr;18(2):163-71.
PubMed 25794202Hopayian K, Danielyan A. Four symptoms define the piriformis syndrome: an updated systematic review of its clinical features. Eur J Orthop Surg Traumatol. 2018 Feb;28(2):155-164. doi: 10.1007/s00590-017-2031-8. Epub 2017 Aug 23.
PubMed 28836092Michel F, Decavel P, Toussirot E, Tatu L, Aleton E, Monnier G, Garbuio P, Parratte B. The piriformis muscle syndrome: an exploration of anatomical context, pathophysiological hypotheses and diagnostic criteria. Ann Phys Rehabil Med. 2013 May;56(4):300-11. doi: 10.1016/j.rehab.2013.03.006. Epub 2013 Apr 30.
PubMed 23684469
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Accuracy of Diagnostic Criteria and Clinical Tests for Piriformis Syndrome
- ClinicalTrials.gov ID
- NCT07473349
- Acronym / sponsor ID
- CTFPIR2025
- Conditions
- Piriformis Syndrome, Gluteal Pain
- Keywords
- Ultrasound-Guided Injection, Piriformis Syndrome, Gluteal Pain, Sciatica, Diagnostic Accuracy, Clinical Tests, Diagnostic Criteria
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 16 Mar 2026 (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.
Piriformis syndrome is a clinical condition characterized by buttock pain and/or sciatic-like symptoms, and its diagnosis remains challenging because there is no universally accepted diagnostic standard. This study aims to evaluate the diagnostic accuracy of commonly used diagnostic criteria and clinical tests for piriformis syndrome. Participants with suspected piriformis syndrome will undergo standardized physical examination and assessment of predefined diagnostic criteria. Ultrasound-guided injection of 5 mL of 2% lidocaine into the piriformis muscle will be used as the reference diagnostic procedure. A reduction of 50% or more in pain after injection will be considered confirmation of piriformis syndrome. The diagnostic performance of clinical tests and diagnostic criteria will be analyzed accordingly.
Detailed description
Piriformis syndrome is one of the possible causes of buttock pain and sciatica-like symptoms; however, its diagnosis is often difficult because of symptom overlap with lumbar radiculopathy, sacroiliac joint disorders, and other musculoskeletal conditions. In clinical practice, several physical examination maneuvers and diagnostic criteria are used, but their diagnostic accuracy has not been sufficiently established.
The aim of this study is to evaluate the diagnostic accuracy of predefined diagnostic criteria and commonly used clinical tests for piriformis syndrome. Adult participants with suspected piriformis syndrome will be recruited prospectively. All participants will undergo a standardized clinical assessment including history taking, physical examination, and evaluation of predefined diagnostic criteria and provocation tests. Clinical examinations will be performed by two physicians according to the study protocol.
As the reference diagnostic procedure, participants will undergo ultrasound-guided injection of 5 mL of 2% lidocaine into the piriformis muscle. The injection will be performed by an experienced physician under ultrasound guidance. Pain severity will be assessed before and after the procedure. A decrease of 50% or more in pain following injection will be accepted as confirmation of piriformis syndrome.
The diagnostic performance of each clinical test and diagnostic criterion set will be evaluated against this reference standard. Sensitivity, specificity, predictive values, likelihood ratios, and overall diagnostic accuracy will be analyzed. The findings of this study are expected to contribute to the development of a more standardized, reliable, and clinically applicable diagnostic approach for piriformis syndrome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo the same standardized diagnostic protocol, including clinical examination, assessment of predefined diagnostic criteria, and ultrasound-guided injection of 5 mL of 2% lidocaine into the piriformis muscle. Diagnostic accuracy will be evaluated in a single-group design.
| Arm | Type | Receives |
|---|---|---|
| Participants With Suspected Piriformis Syndrome | Experimental | Diagnostic Test: Ultrasound-Guided Piriformis InjectionParticipants with suspected piriformis syndrome will undergo standardized clinical assessment and the diagnostic intervention defined as Ultrasound-Guided Piriformis Injection, consisting of ultrasound-guided injection of 5 mL of 2% lidocaine into the piriformis muscle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 75 years
- Presentation with gluteal pain
- Pain on palpation in the piriformis region
Key exclusion criteria (12 listed)
- History of injection to the lumbar, hip, or gluteal region within the last 3 months,including steroid, hyaluronic acid, or similar injections
- History of hip surgery
- Presence of active inflammatory rheumatic disease, including rheumatoid arthritis, ankylosing spondylitis, polymyalgia rheumatica, vasculitis, or similar conditions
- Active skin or subcutaneous soft tissue infection in the gluteal region
- Use of anticoagulant therapy that may contraindicate injection
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 |
|---|---|---|
| Ultrasound-Guided Piriformis InjectionUltrasound-guided injection of 5 mL of 2% lidocaine into the piriformis muscle for diagnostic confirmation. A patient-reported pain reduction of 50% or more at 1 hour after injection will be considered confirmation of piriformis syndrome. | Diagnostic test | Participants With Suspected Piriformis Syndrome |
Primary outcome
Diagnostic accuracy of clinical tests and diagnostic criteria for piriformis syndrome
Time frame: Same day; pain response assessed 1 hour after injection
Diagnostic accuracy of predefined clinical tests and diagnostic criteria will be evaluated using pain response to ultrasound-guided piriformis injection as the reference standard. A positive reference standard result will be defined as a patient-reported reduction of 50% or more in pain at 1 hour after injection compared with pre-injection pain. Participants with a positive reference standard result will be classified as having piriformis syndrome for the diagnostic accuracy analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Results publication: PubMed 25794202Misirlioglu TO, Akgun K, Palamar D, Erden MG, Erbilir T. Piriformis syndrome: comparison of the effectiveness of local anesthetic and corticosteroid injections: a double-blinded, randomized controlled study. Pain Physician. 2015 Mar-Apr;18(2):163-71.
- Results publication: PubMed 28836092Hopayian K, Danielyan A. Four symptoms define the piriformis syndrome: an updated systematic review of its clinical features. Eur J Orthop Surg Traumatol. 2018 Feb;28(2):155-164. doi: 10.1007/s00590-017-2031-8. Epub 2017 Aug 23.
- Results publication: PubMed 23684469Michel F, Decavel P, Toussirot E, Tatu L, Aleton E, Monnier G, Garbuio P, Parratte B. The piriformis muscle syndrome: an exploration of anatomical context, pathophysiological hypotheses and diagnostic criteria. Ann Phys Rehabil Med. 2013 May;56(4):300-11. doi: 10.1016/j.rehab.2013.03.006. Epub 2013 Apr 30.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data has not yet been determined.
Related trials for Piriformis Syndrome
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Comparative Effects of Post-Isometric Relaxation and Reciprocal Inhibition Techniques inPiriformis Syndrome
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Piriformis Injection in people with Piriformis Syndrome and Gluteal Pain, run by Istanbul University - Cerrahpasa 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 12 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: opening soon, as of the sponsor's last update on 17 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Busra Nur Aslantas, MD (+905075985562, busra.kaya1@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of clinical tests and diagnostic criteria for piriformis syndrome (time frame: Same day; pain response assessed 1 hour after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07473349, which also lists 3 linked publications.
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 17 Mar 2026.