Diagnostic Accuracy of Clinical Tests and Diagnostic Criteria for Piriformis Syndrome

NCT07473349 | Not Yet Recruiting

• 1 other identifier: CTFPIR2025
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Piriformis Syndrome; Gluteal Pain

Keywords

Ultrasound-Guided Injection; Piriformis Syndrome; Gluteal Pain; Sciatica; Diagnostic Accuracy; Clinical Tests; Diagnostic Criteria

Outcome Measures

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.

  Same day; pain response assessed 1 hour after injection

Study Arms (1)

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.

Diagnostic Test: Ultrasound-Guided Piriformis Injection

Interventions

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.

Participants With Suspected Piriformis Syndrome

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 25794202 RESULT

• Hopayian 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.

  PMID: 28836092 RESULT

• Michel 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.

  PMID: 23684469 RESULT

MeSH Terms

Conditions

Piriformis Muscle Syndrome; Sciatica

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Central Study Contacts

Busra Nur Aslantas, MD

CONTACT

+905075985562; busra.kaya1@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Physical Medicine and Rehabilitation Department

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

TU (1)