Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-01 @ 10:47 AM
Study NCT ID:
NCT04867356
Status:
COMPLETED
Last Update Posted:
2021-07-07
First Post:
2021-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects Of Latissimus Dorsi Stretching On Functional Disability Related To Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-04', 'studyFirstSubmitDate': '2021-04-27', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry disability index', 'timeFrame': '2 weeks', 'description': "The Oswestry Disability Index (aka the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test has been around since 1980 and is considered the 'gold standard' of low back pain functional outcome tools. SCORE DISABILITY LEVEL 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled The Oswestry Disability Index (aka the Oswestry Low Back Pain Disability Questionnaire) is an ex- tremely important tool that researchers and disability evaluators use"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to determine effects of latissimus dorsi stretching on functional disability related to chronic low back pain', 'detailedDescription': 'A single-blinded,randomized clinical trial will be conducted in /multiple rehabilitation centers of Rawalpindi and Islamabad, after taking approval from ERB/IRB respective centers. The study duration will be 3 months. the study participants will be having mechanical low back pain.\n\nThe intervention will be included latissmus dorsi stretching along with spinal stabilization exercises in one group and in comparative group spinal stabilization exercises alone. Oswestry Disability Index (ODI) will be used to measure the disability related to the chronic low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male and female\n* 20 to 60 years\n* chronic mechanical low back pain\n\nExclusion Criteria:\n\n* patients who had any type of injury or fracture which limits rehabilitation\n* patients with the symptoms of radiating pain\n* who had disc pathology and spinal cord injury\n* patients with medical conditions'}, 'identificationModule': {'nctId': 'NCT04867356', 'briefTitle': 'Effects Of Latissimus Dorsi Stretching On Functional Disability Related To Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Health Education Research Foundation (HERF)'}, 'officialTitle': 'Effects Of Latissimus Dorsi Stretching On Functional Disability Related To Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'HERF/REC/2021-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Spinal Stabilization Exercises (SSE)', 'interventionNames': ['Other: Spinal Stabilization Exercises (SSE)']}, {'type': 'EXPERIMENTAL', 'label': 'Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)', 'interventionNames': ['Other: Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)']}], 'interventions': [{'name': 'Spinal Stabilization Exercises (SSE)', 'type': 'OTHER', 'description': 'Spinal stabilization exercises (SSE) including bridging, planks and tummy tuck-in will be performed. Each participant received a total 7 session thrice a week sessions in two weeks, . Each session had lasted for 30-40 minutes. Spinal stabilization exercises were repeated 5-15 times depending on the endurance of patients.\n\nHome exercise plan will also be given e.g. postural care, precautions in lifting and carrying weights etc.', 'armGroupLabels': ['Spinal Stabilization Exercises (SSE)']}, {'name': 'Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)', 'type': 'OTHER', 'description': 'In experimental group in addition SSE group interventions, participants will receive the latissimus dorsi stretching (LDS). Each participant received a total 7 session thrice a week sessions in two weeks. Each session had lasted for 30-40 minutes. each stretch of latissimus dorsi was of 20-30 seconds with 10-20 repetitions in each session.', 'armGroupLabels': ['Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'MÄnsehra', 'country': 'Pakistan', 'facility': 'NOSIS clinics Mansehra Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Health Education Research Foundation (HERF)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}