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NCT Number: NCT07473349

Diagnostic Accuracy of Clinical Tests and Diagnostic Criteria 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Location contact

Busra Nur Aslantas, MD

CONTACT

[email protected]

+905075985562

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 to 75 years
  • Presentation with gluteal pain
  • Pain on palpation in the piriformis region

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Ultrasound-Guided Piriformis Injection

Diagnostic 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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Busra Nur Aslantas, MD

CONTACT

[email protected]

+905075985562

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Evaluation of the Diagnostic Accuracy of Diagnostic Criteria and Clinical Tests for Piriformis Syndrome

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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