Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-29 @ 7:26 PM
Study NCT ID:
NCT07099768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-01
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between the Flexibility of Hip Muscles, Pain and Disability in Chronic Nonspecific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2025-07-25', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flexibility of Hip Muscles', 'timeFrame': 'up to 1 day', 'description': 'Flexibility of the muscles of hip will be conducted on both the right and lift side and will be measure by universal Goniometer'}, {'measure': 'Pain Intensity', 'timeFrame': 'up to 1 day', 'description': "Visual analog scale is globally used as a measure of pain intensity. Visual analogue scale is the most frequent outcome tools in musculoskeletal pain assessment. An overall score between 0 and 10 points is given, with 'no pain' defined as 0 points and 'the most severe pain possible' defined as 10 points."}, {'measure': 'Disability', 'timeFrame': 'up to 1 day', 'description': 'Oswestry disability index is an internally consistent, unidimensional scale with overall excellent construct validity and ability to discriminate the severity of functional disability. The analysis suggests that the Oswestry disability index may better distinguish between the relative degrees of function at above-average disability levels. The Oswestry disability index is used to assess the extent of disability caused by low back pain, The Oswestry disability index consists of 10 questions on pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual activity, social life, and travel. Performance in each item is described in 6 stages, from 0 to 5 points, A higher score on the Oswestry disability index indicates more severe disability'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Correlation', 'Flexibility of Hip Muscles', 'Pain', 'Disability', 'Nonspecific Low Back Pain'], 'conditions': ['Non Specific Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to investigate the correlation between the flexibility of hip muscles; hip flexors (iliopsoas, rectus femoris), hip extensors (hamstring), hip internal rotators, hip external rotators, hip adductors and hip abductors with pain intensity and disability level among patients with chronic nonspecific low back pain', 'detailedDescription': "Low back pain is considered the primary cause of disability worldwide. Low back pain is pain located at the area from the last ribs to the gluteal region with or without radiation to the lower limbs. Low back pain is associated with substantial economic burden, resulting from healthcare expenses, reduced productivity, insurance costs and sick leaves.\n\nIt was reported that limitation of hip range of motion of low-back pain patients was significantly different from that of healthy person. Due to the anatomic proximity and muscle connections, a number of studies have investigated the relationship between hip mobility and episodes of low back pain. From biomechanical point of view limited hip range of motion is compensated by hypermobility of the lumbar region thus generating overload with repetitive compensatory movements in the back.\n\nPatients with non-specific low back pain demonstrate alteration in hip muscles flexibility. This relationship is important because the hip muscles act as an important link between the lower limbs and the trunk exerting forces from the lower limbs to the spine as well as from the spine. Any flexibility limitations of hip muscles not only decreases the range of motion but can also cause excessive mechanical stresses to lumbar spine during particular movement, thus affecting gait and other functional movements.\n\nUp to the author's knowledge, there is few studies that investigates the correlation between the flexibility of all hip muscles and pain intensity and disability level in nonspecific low back pain patients. Therefore, this study aims to assess the correlation between the flexibility of hip muscles; hip flexors (iliopsoas, rectus femoris), hip extensors (hamstring), hip internal rotators, hip external rotators, hip adductors and hip abductors with pain intensity and disability among patients with chronic nonspecific low back pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50 patients with chronic non specific low back pain from both gender will participate in this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic nonspecific low back pain for at least 3 months.\n* Age of the patient will range from 20 and 45 years.\n* Pain intensity of three or higher based on the visual analogue scale (VAS, 0-10 scale).\n* .Body Mass Index from 18-25 kg/m2.\n\nExclusion Criteria:\n\n* spinal surgery, spinal or pelvic fracture.\n* ankylosing spondylitis or rheumatoid arthritis.\n* spondylolisthesis or spondylolysis, neurological disorders.\n* spinal inflammation or tumor. osteoporosis.\n* Continuous use of pain medications.\n* respiratory disease or heart disease.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT07099768', 'acronym': 'NSLBP', 'briefTitle': 'Correlation Between the Flexibility of Hip Muscles, Pain and Disability in Chronic Nonspecific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Correlation Between the Flexibility of Hip Muscles, Pain and Disability in Chronic Nonspecific Low Back Pain', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005813'}}, 'armsInterventionsModule': {'armGroups': [{'label': '50 subjects aged between 20 and 45 years of both sexes with diagnosis of nonspecific low back pain'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shimaa Mohamed, Master', 'role': 'CONTACT', 'email': 'salmatony55@gmail.com', 'phone': '0 11 46738650'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator: Shimaa Rabie Tony Mohamed', 'investigatorFullName': 'Shimaa Rabie Tony Mohamed', 'investigatorAffiliation': 'Cairo University'}}}}