Diagnostic Accuracy of Clinical Tests and Diagnostic Criteria for Piriformis Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 75 years
Presentation with gluteal pain
Pain on palpation in the piriformis region
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Ultrasound-Guided Piriformis Injection
Diagnostic testUltrasound-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.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Participants With Suspected Piriformis SyndromeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Same day; pain response assessed 1 hour after injectionSponsors and contacts
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Source ClinicalTrials.gov
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