## Protocol Section
### Identification Module
**NCT ID:** NCT06435169

**Brief Title:** Comparative Presence of Piriformis Syndrome in Patients With Lumbar Disc Bulging and Protrusion

**Official Title:** Comparative Presence of Piriformis Syndrome in Patients With Lumbar Disc Bulging and Protrusion

#### Organization Study ID Info
**ID:** Yuzuncu Yil University Türkiye
#### Organization
**Class:** OTHER
**Full Name:** Yuzuncu Yıl University
### Status Module
#### Completion Date
**Date:** 2024-05-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-01

**Type:** ACTUAL

#### Start Date
**Date:** 2024-03-04

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Yuzuncu Yıl University

#### Responsible Party

**Investigator Affiliation:** Yuzuncu Yıl University

**Investigator Full Name:** Volkan Şah

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Clinicians consider lumbar disc herniation more prominently in the differential diagnosis than piriformis syndrome, as it is the most common cause of sciatica, and this canalizes them to overlook that the sciatic nerve may be compressed by the piriformis muscle, below the L4-L5-S1 intervertebral disc levels.

As far as is known, there are no 'patient series' in the literature regarding the incidence of Piriformis syndrome in Lumbar Disc Herniation, only one case report has been found. This clinical study aims to reveal that Piriformis syndrome may also be present in patients with disc herniation on Magnetic Resonance Imaging (MRI), and that sometimes it may even be the main cause of sciatic nerve pain.

**Detailed Description:** In this study, the participants between the ages of 18-65, who were diagnosed with L4-L5 and/or L5-S1 Lumbar Disc Herniation (bulging and protrusion) by having a Lumbar MRI at the Faculty of Medicine Sports Medicine outpatient clinic, were reached through their contact numbers, and those who had not previously undergone waist/hip surgery and those who described unilateral sciatica complaints (hip-leg-foot pain and numbness) during the interview were invited to Yüzüncü Yıl University Faculty of Medicine Sports Medicine polyclinic and Lasegue's, Flexion Adduction Internal Rotation (FAIR) and Freiberg's tests were performed.

### Conditions Module

**Conditions:**

- Piriformis Syndrome

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 76

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Lasegue's test, FAIR (Flexion Adduction Internal Rotation) test and, Freiberg's test will be performed in a single check-up for patients diagnosed with L4-L5 and/or L5-S1 Lumbar Disc Herniation (bulging) by lumbar Magnetic Resonance Imaging (MRI). The presence of Piriformis syndrome was investigated in these patients with Freiberg and FAIR tests.

**Intervention Names:**

- Diagnostic Test: Lasegue's, Freiberg's and, FAIR (Flexion Adduction Internal Rotation) tests.

**Label:** 38 patients with lumbar disc bulging

#### Arm Group 2

**Description:** Lasegue's, FAIR (Flexion Adduction Internal Rotation) and, Freiberg's test will be performed in a single check-up for patients diagnosed with L4-L5 and/or L5-S1 Lumbar Disc Herniation (protrusion) by lumbar Magnetic Resonance Imaging (MRI). The presence of Piriformis syndrome was investigated in these patients with Freiberg and FAIR tests.

**Intervention Names:**

- Diagnostic Test: Lasegue's, Freiberg's and, FAIR (Flexion Adduction Internal Rotation) tests.

**Label:** 38 patients with lumbar disc protrusion

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 38 patients with lumbar disc bulging

- 38 patients with lumbar disc protrusion

**Description:** The Straight Leg Raise test or Lasegue test, is also crucial in detecting disc herniation and neural compression. Lasègue's sign is said to be positive if the angle to which the leg can be raised (upon straight leg raising) before eliciting pain is \<45°.The presence of Piriformis syndrome was investigated in these patients with Freiberg and FAIR tests. Freiberg's test elicits pain by passively internal rotation of the extended hip, when the patient is in supine. The purpose of this test is on the one hand stretching of the irritated Piriformis Muscle (PM), on the other hand provoking sciatic nerve compression. The FAIR test is a sensitive and specific test for detection if irritation of the sciatic nerve by the piriformis. FAIR stands for flexion, adduction and internal rotation. Also known as piriformis test.

**Name:** Lasegue's, Freiberg's and, FAIR (Flexion Adduction Internal Rotation) tests.

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** The Straight Leg Raise test or Lasegue test, is also crucial in detecting disc herniation and neural compression. Lasègue's sign is said to be positive if the angle to which the leg can be raised (upon straight leg raising) before eliciting pain is \<45°.

**Measure:** Lasegue's Test

**Time Frame:** Baseline

**Description:** Freiberg's test elicits pain by passively internal rotation of the extended hip, when the patient is in supine. The purpose of this test is on the one hand stretching of the irritated piriformis muscle, on the other hand provoking sciatic nerve compression.

**Measure:** Freiberg's Test

**Time Frame:** Baseline

**Description:** The FAIR test is a sensitive and specific test for detection if irritation of the sciatic nerve by the piriformis. FAIR stands for flexion, adduction and internal rotation. Also known as piriformis test.

**Measure:** FAIR (Flexion Adduction Internal Rotation) test

**Time Frame:** Baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Being between the ages of 18-65
* Having unilateral sciatica
* Having disk herniation in the form of bulging or protrusion in a previous Lumbar Magnetic Resonance Imaging (MRI)

Exclusion Criteria:

* Having bilateral sciatica
* Having disc herniation in the form of extrusion or sequestration in a previous Lumbar Magnetic Resonance Imaging (MRI)
* Previous back and/or hip surgery

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients of both genders between the ages of 18-65 with lumbar disc bulging or protrusion

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Van

**Country:** Turkey

**Facility:** Volkan Şah

**Zip:** 65080

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020426

- Term: Sciatic Neuropathy

- ID: D000020422

- Term: Mononeuropathies

- ID: D000010523

- Term: Peripheral Nervous System Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009408

- Term: Nerve Compression Syndromes

- ID: D000009437

- Term: Neuralgia

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000017699

- Term: Pelvic Pain

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M28404

- Name: Piriformis Muscle Syndrome

- Relevance: HIGH

- As Found: Piriformis Syndrome

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M22222

- Name: Sciatic Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: M22218

- Name: Mononeuropathies

- Relevance: LOW

- As Found: Unknown

- ID: M13432

- Name: Peripheral Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12352

- Name: Nerve Compression Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M5853

- Name: Charcot-Marie-Tooth Disease

- Relevance: LOW

- As Found: Unknown

- ID: M18092

- Name: Hereditary Sensory and Motor Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: M12381

- Name: Neuralgia

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M19918

- Name: Pelvic Pain

- Relevance: LOW

- As Found: Unknown

- ID: T4568

- Name: Piriformis Syndrome

- Relevance: HIGH

- As Found: Piriformis Syndrome

- ID: T1081

- Name: Charcot-Marie-Tooth Disease

- Relevance: LOW

- As Found: Unknown

- ID: T2761

- Name: Hereditary Motor and Sensory Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: T2766

- Name: Hereditary Neuropathy With Liability to Pressure Palsies

- Relevance: LOW

- As Found: Unknown

- ID: T5067

- Name: Roussy Levy Syndrome

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000055958

- Term: Piriformis Muscle Syndrome

- ID: D000013577

- Term: Syndrome

### Misc Info Module

- Version Holder: 2024-05-31
