- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06783439
Ultrasonographic Evaluation of the Sciatic Nerve in Patients With Piriformis Syndrome (Sciatica)
February 28, 2026 updated by: Busra Sezer Kıral, Istanbul University - Cerrahpasa
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The sciatic nerve is the largest nerve in the body and is formed by the ventral roots of the lumbosacral plexus (L4-S3), passes through the foramen ischiadicum majus under the piriformis muscle (PM) and enters the gluteal region.
It is controversial whether anatomical variations in the sciatic nerve and PM predispose to the development of Piriformis syndrome (PS).
The sciatic nerve passes under the PM as a single branch in almost 90% of cases.
However, there are some variations where it passes above and through the muscle or divides into tibial and peroneal branches, with one branch passing under the piriformis.
There are a number of studies in the literature evaluating the PM with US.
These studies have shown that the PM thickness and echogenicity increase on the pathological side.
In addition, it has been mentioned that the sciatic nerve has a coarse and blurry image in patients complaining of sciatic pain.
In one study, cross-sectional area measurement was performed instead of PM thickness measurement.
However, this was criticized in later studies, and it was stated that it was difficult to calculate muscle volume exactly with two-dimensional US due to the irregular shape of the PM, which is anatomically pear-shaped, and that thickness measurement would provide more accurate results instead of cross-sectional area.
In the first study in the literature focusing on the sciatic nerve in PS and the neuropathic pain it causes, it was found that the sciatic nerve was significantly enlarged (75%) on the symptomatic side and had decreased echogenicity in some patients when compared to healthy volunteers.
Study Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- İstanbul Üniversitesi - Cerrahpasa (IUC)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability 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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
numeric scale
Time Frame: five months
|
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)
Time Frame: five months
|
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)
Time Frame: five months
|
Piriformis muscle thickness will be measured with ultrasound on the symptomatic and asymptomatic sides in the same patient.
|
five months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Selim Sezikli, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2024
Primary Completion (Actual)
April 1, 2025
Study Completion (Actual)
April 1, 2025
Study Registration Dates
First Submitted
January 7, 2025
First Submitted That Met QC Criteria
January 14, 2025
First Posted (Actual)
January 20, 2025
Study Record Updates
Last Update Posted (Actual)
March 3, 2026
Last Update Submitted That Met QC Criteria
February 28, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Pelvic Pain
- Mononeuropathies
- Nerve Compression Syndromes
- Sciatic Neuropathy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Sciatica
- Piriformis Muscle Syndrome
- Physical Phenomena
- Radiation
- Radiation, Nonionizing
- Ultrasonic Waves
- Sound
- High-Energy Shock Waves
Other Study ID Numbers
- 2024-69
- Istanbul PMR (Other Identifier: Istanbul PMR Training and Research Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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