NCT06783439

Brief Summary

Piriformis syndrome (PS) is defined as a neuropathy of entrapment resulting from compression and irritation of the sciatic nerve at the level of the piriformis muscle (PM) at the pelvic outlet, causing sciatica radiating to the leg. The neuropathic component of PS is the compression of the sciatic nerve in or around the PM, while the primary cause of the somatic component is myofascial pain of the PM. PS accounts for 6-8% of all hip and sciatic pain cases. It is more common in middle-aged patients, and the most common etiological cause is trauma. There are various methods for the diagnosis of Piriformis Syndrome. Clinically, tenderness on palpation of the PM is the most common symptom. The FAIR test (passive flexion abduction and internal rotation of the hip), the Freiberg test (forceful internal rotation of the thigh in the supine position), the Pace test (abduction of the leg against resistance while sitting) and the Beatty maneuver (active abduction of the thigh on the affected side in the lateral decubitus position) are maneuvers that help in diagnosis. It is known that there is a delay in proximal nerve conduction (H-reflex) on the pathological side compared to the healthy side in the FAIR maneuver on EMG in PS, and it is not a sufficient test for diagnosis alone. Some studies have reported increased piriformis thickness on the pathological side in MRI. None of these clinical and imaging methods are sufficient for diagnosis alone, and today ultrasonography (US) has become one of the most important imaging methods for musculoskeletal clinicians in the diagnosis of PS. Imaging with US and the diagnostic injection test applied to the piriformis muscle with US guidance are quite important for diagnosis. There are a number of studies in the literature evaluating PM with US. These studies have shown that the piriformis muscle thickness and echogenicity increase on the pathological side. However, there is a lack of studies in the literature focusing on the evaluation of the sciatic nerve with US in patients with PS. Our aim in this study is to compare the thickness of the PM and the sciatic nerve by measuring US on both the pathological and painless sides in patients with unilateral hip pain who were diagnosed with PS clinically, to record the variations present in the sciatic nerve, and to determine whether the myofascial pain or the neuropathic component is dominant in the disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 7, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

January 7, 2025

Last Update Submit

February 28, 2026

Conditions

Keywords

Piriformis Muscle SyndromeSciatica

Outcome Measures

Primary Outcomes (3)

  • numeric scale

    Tenderness in the piriformis muscle will be assessed by palpation using the numerical scale (NRS). The numerical scale is a pain score and is evaluated between 0 and 10.

    five months

  • Sciatic nerve thickness (measurement with US)

    Sciatic nerve thickness will be measured with ultrasound on the symptomatic and asymptomatic sides in the same patient.

    five months

  • Piriformis muscle thickness (measurement with US)

    Piriformis muscle thickness will be measured with ultrasound on the symptomatic and asymptomatic sides in the same patient.

    five months

Study Arms (2)

symptomatic hip

Patients aged between 18 and 70 years with unilateral hip and/or leg pain, positive FAIR (flexion, adduction, internal rotation) test, and tenderness to palpation in the PM will be included in our study.

Other: Ultrasound

asymptomatic hip

Patients aged between 18 and 70 years with unilateral hip and/or leg pain, positive FAIR (flexion, adduction, internal rotation) test, and tenderness to palpation in the PM will be included in our study.

Other: Ultrasound

Interventions

The ultrasound probe will be placed parallel to the body of the piriformis muscle on an imaginary line drawn from the sacrum to the greater trochanter of the femur. This area is also the sensitive area of the patients during the examination with pressure, and when the US probe is in this position, the subcutaneous fat tissue, gluteus maximus muscle, piriformis muscle, and the upper and lower borders of the sciatic nerve will be displayed in order from superficial to deep. First, the maximum thickness of the piriformis muscle body will be measured, then the thickness of the sciatic nerve will be measured, and the same measurements will be applied to the patient's asymptomatic hip, and the measurements will be recorded.

asymptomatic hipsymptomatic hip

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged between 18 and 70 years with unilateral hip and/or leg pain, positive FAIR (flexion, adduction, internal rotation) test, and tenderness to palpation in the PM will be included in our study.

You may qualify if:

  • Patients aged between 18 and 70 years with unilateral hip and/or leg pain
  • Positive FAIR (flexion, adduction, internal rotation) test
  • Tenderness to palpation in the Piriformis muscle

You may not qualify if:

  • Patients with a history of previous surgery involving the lumbar and/or hip region
  • A history of malignancy or infection in the pelvic region
  • Body mass index (BMI) Greater than 30 kg/m2
  • Psychiatric diseases
  • Vascular disease
  • Uncontrolled diabetes, hypertension or heart failure,
  • Disc pathologies that may cause radiculopathy
  • History of rheumatic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Üniversitesi - Cerrahpasa (IUC)

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SciaticaPiriformis Muscle Syndrome

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNerve Compression SyndromesPelvic Pain

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Selim Sezikli

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

January 7, 2025

First Posted

January 20, 2025

Study Start

December 1, 2024

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations