Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-13 @ 11:16 PM
Study NCT ID:
NCT06435169
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2024-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Presence of Piriformis Syndrome in Patients With Lumbar Disc Bulging and Protrusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055958', 'term': 'Piriformis Muscle Syndrome'}], 'ancestors': [{'id': 'D020426', 'term': 'Sciatic Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2024-05-23', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Lasegue's Test", 'timeFrame': 'Baseline', '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': "Freiberg's Test", 'timeFrame': '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': 'FAIR (Flexion Adduction Internal Rotation) test', 'timeFrame': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Piriformis Syndrome']}, 'descriptionModule': {'briefSummary': "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.\n\nAs 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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of both genders between the ages of 18-65 with lumbar disc bulging or protrusion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 18-65\n* Having unilateral sciatica\n* Having disk herniation in the form of bulging or protrusion in a previous Lumbar Magnetic Resonance Imaging (MRI)\n\nExclusion Criteria:\n\n* Having bilateral sciatica\n* Having disc herniation in the form of extrusion or sequestration in a previous Lumbar Magnetic Resonance Imaging (MRI)\n* Previous back and/or hip surgery'}, 'identificationModule': {'nctId': 'NCT06435169', 'briefTitle': 'Comparative Presence of Piriformis Syndrome in Patients With Lumbar Disc Bulging and Protrusion', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'Comparative Presence of Piriformis Syndrome in Patients With Lumbar Disc Bulging and Protrusion', 'orgStudyIdInfo': {'id': 'Yuzuncu Yil University Türkiye'}}, 'armsInterventionsModule': {'armGroups': [{'label': '38 patients with lumbar disc bulging', '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.", 'interventionNames': ["Diagnostic Test: Lasegue's, Freiberg's and, FAIR (Flexion Adduction Internal Rotation) tests."]}, {'label': '38 patients with lumbar disc protrusion', '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.", 'interventionNames': ["Diagnostic Test: Lasegue's, Freiberg's and, FAIR (Flexion Adduction Internal Rotation) tests."]}], 'interventions': [{'name': "Lasegue's, Freiberg's and, FAIR (Flexion Adduction Internal Rotation) tests.", 'type': 'DIAGNOSTIC_TEST', '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.", 'armGroupLabels': ['38 patients with lumbar disc bulging', '38 patients with lumbar disc protrusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65080', 'city': 'Van', 'country': 'Turkey (Türkiye)', 'facility': 'Volkan Şah', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Volkan Şah', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}