Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:03 AM
Study NCT ID:
NCT07480759
Status:
COMPLETED
Last Update Posted:
2026-03-20
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Load Blood Flow Restriction Training Versus Traditional Heavy Load Resistance Training in Male Athletes With Sub-acute Non-specific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2026-03-15', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Pain Rating Scale (NPRS) for Pain Intensity in Sub-Acute Non-Specific Low Back Pain', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Pain intensity in participants with sub-acute non-specific low back pain will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point self-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will be asked to rate their average low back pain during the past 24 hours by selecting a number from 0 to 10.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sub-acute Non-specific Low Back Pain']}, 'descriptionModule': {'briefSummary': 'his randomized clinical trial aims to compare the effects of low-load blood flow restriction (LL-BFR) training and traditional heavy-load resistance training (HL-RT) on male athletes with sub-acute non-specific low back pain. Participants will be randomly assigned to either the LL-BFR or HL-RT group for a specified intervention period. Both groups will perform supervised exercise sessions targeting core and lumbar stabilizing muscles. Outcomes including pain intensity, functional disability, and muscle strength will be assessed at baseline and post-intervention. The study seeks to determine whether LL-BFR can provide comparable or superior benefits to HL-RT while reducing mechanical stress on the lumbar spine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Male athletes (Liu et al., 2025)\n\n * Age 18-24 years (Liu et al., 2025)\n * Athletes like wrestlers, weightlifters and sprinters\n * Report pain and discomfort localized below the costal margin and above the inferior gluteal folds. (Adhikari et al., 2021)\n * Subacute low back pain - Pain lasting between 4 to 12 weeks. (Chou \\& Atlas, 2023)\n * Participants with moderate level of pain on Visual analogue scale.(Nambi et al., 2022)\n * Negative straight-leg-raising (SLR) test, which is useful for diagnosing lumbar disc herniation. (Jardim et al., 2022)\n * No dominant leg pain from radicular or cauda equina disorders. (Liu et al., 2025)\n * No history of previous lumbar or thoracolumbar spine surgery. (Jardim et al., 2022)\n\nExclusion Criteria:\n\n* Any prior lumbar or thoracolumbar spine surgery (Liu et al., 2025)\n* A history of cancer, spinal infection, rheumatologic diseases, spine fracture, red flag signs (such as significant and unexplained weight loss exceeding 10% of total body weight within the past six months, and presence of fever), psychological disorders, and previous spine surgery, radiculopathy, anatomical or congenital abnormalities. (Hernandez-Lucas et al., 2023)\n* History of peripheral arterial disease or deep vein thrombosis. (Jardim et al., 2022)'}, 'identificationModule': {'nctId': 'NCT07480759', 'briefTitle': 'Low Load Blood Flow Restriction Training Versus Traditional Heavy Load Resistance Training in Male Athletes With Sub-acute Non-specific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Lahore'}, 'officialTitle': 'Low Load Blood Flow Restriction Training Versus Traditional Heavy Load Resistance Training in Male Athletes With Sub-acute Non-specific Low Back Pain', 'orgStudyIdInfo': {'id': 'Mahnoor Ijaz'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Load Blood Flow Restriction Training (LL-BFR)', 'interventionNames': ['Other: Low Load Blood Flow Restriction Training (LL-BFR)', 'Other: Traditional Heavy Load Resistance Training (HL-RT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Heavy Load Resistance Training (HL-RT)', 'interventionNames': ['Other: Low Load Blood Flow Restriction Training (LL-BFR)', 'Other: Traditional Heavy Load Resistance Training (HL-RT)']}], 'interventions': [{'name': 'Low Load Blood Flow Restriction Training (LL-BFR)', 'type': 'OTHER', 'description': 'Participants will perform low-load resistance exercises with elastic occlusion cuffs on the proximal thighs, combined with four core exercises (Glute Bridge, Wall Sit, Step-Ups, Bird-Dog). Sessions last 50 minutes, three times per week for 4 weeks. Exercise intensity starts at 20% of 1RM and progresses to 35%, with sets and repetitions designed to improve core strength, reduce pain, and enhance spinal stabilization.', 'armGroupLabels': ['Low Load Blood Flow Restriction Training (LL-BFR)', 'Traditional Heavy Load Resistance Training (HL-RT)']}, {'name': 'Traditional Heavy Load Resistance Training (HL-RT)', 'type': 'OTHER', 'description': 'Participants will perform high-load resistance exercises without occlusion cuffs, using the same four core exercises. Sessions last 55 minutes, three times per week for 4 weeks. Intensity starts at 50% of 1RM and progresses to 75-80%, with sets and repetitions aimed at improving muscle strength, core stability, and reducing pain and functional disability.', 'armGroupLabels': ['Low Load Blood Flow Restriction Training (LL-BFR)', 'Traditional Heavy Load Resistance Training (HL-RT)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'country': 'Pakistan', 'facility': 'UIPT, UOL, Lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mahnoor Ijaz', 'investigatorAffiliation': 'University of Lahore'}}}}