Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT06778694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-19
First Post:
2025-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effects of Motor Control and Isolated Strengthening Lumbar Exercises on Functional Outcomes in Patients with Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2025-01-12', 'studyFirstSubmitQcDate': '2025-01-12', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NPRS', 'timeFrame': 'Baseline and after 2 and 4 weeks of treatment', 'description': 'Comparison on effect of pain'}], 'secondaryOutcomes': [{'measure': 'Oswestry disability Questionnaire', 'timeFrame': 'Baseline and after 2 and 4 weeks of treatment', 'description': 'Comparison on functional outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Low-back Pain']}, 'referencesModule': {'references': [{'pmid': '26742533', 'type': 'BACKGROUND', 'citation': 'Saragiotto BT, Maher CG, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Macedo LG. Motor control exercise for chronic non-specific low-back pain. Cochrane Database Syst Rev. 2016 Jan 8;2016(1):CD012004. doi: 10.1002/14651858.CD012004.'}, {'pmid': '39285790', 'type': 'BACKGROUND', 'citation': 'Fanuscu A, Oz M, Ozel Asliyuce Y, Turhan E, Ulger O. Effects of Clinic-based and Telerehabilitation-based Motor Control Exercises in Individuals with Chronic Low-back Pain: A Randomized Controlled Trial With 3-Month Follow-up. Clin J Pain. 2024 Dec 1;40(12):700-708. doi: 10.1097/AJP.0000000000001245.'}, {'pmid': '29156985', 'type': 'BACKGROUND', 'citation': 'Steele J, Bruce-Low S, Smith D, Jessop D, Osborne N. Isolated Lumbar Extension Resistance Training Improves Strength, Pain, and Disability, but Not Spinal Height or Shrinkage ("Creep") in Participants with Chronic Low Back Pain. Cartilage. 2020 Apr;11(2):160-168. doi: 10.1177/1947603517695614. Epub 2017 Feb 1.'}, {'pmid': '29035297', 'type': 'BACKGROUND', 'citation': 'Steele J, Fisher J, Bruce-Low S, Smith D, Osborne N, Newell D. Variability in Strength, Pain, and Disability Changes in Response to an Isolated Lumbar Extension Resistance Training Intervention in Participants with Chronic Low Back Pain. Healthcare (Basel). 2017 Oct 16;5(4):75. doi: 10.3390/healthcare5040075.'}, {'pmid': '37762861', 'type': 'BACKGROUND', 'citation': 'Fortin M, Rye M, Roussac A, Montpetit C, Burdick J, Naghdi N, Rosenstein B, Bertrand C, Macedo LG, Elliott JM, Dover G, DeMont R, Weber MH, Pepin V. The Effects of Combined Motor Control and Isolated Extensor Strengthening versus General Exercise on Paraspinal Muscle Morphology, Composition, and Function in Patients with Chronic Low Back Pain: A Randomized Controlled Trial. J Clin Med. 2023 Sep 12;12(18):5920. doi: 10.3390/jcm12185920.'}]}, 'descriptionModule': {'briefSummary': 'Comparative effects of motor control and isolated strengthening lumbar exercises on functional outcomes in patients with chronic low back pain', 'detailedDescription': 'As there is an increasing population of low back pain because of the stress and workload that lead to poor posture. Poor posture leads to tightening of flexor muscles and weakness of lumbar extensors that knowns as lower cross syndrome and it will become the chronic low back pain if not treated on time. Most of the therapist only work on the pain management but not focus on the functional outcome of the patient so the isolated lumbar extensor strengthening exercises and motor control exercises should be evaluated to know the effectiveness in improving the functional outcome of patients.\n\nTo compare the effects of motor control and isolated strengthening lumbar exercises on functional outcome in patients with chronic low back pain. A randomized controlled trial with a sample of 35 patients with chronic low back pain will be taken from Physiotherapy OPDs of Madinah Teaching Hospital, Allied hospital, In motion physiotherapy clinic and The Physio Rehab clinic. Participants will be randomly divided into two groups using convenient sampling technique. Both groups will be experimental groups. Patients in Group A will do Motor control exercises. Patients in Group B will do isolated strengthening lumbar exercises. Hot pack will be applied for 15 minutes and Ultrasound therapy (1MHz) for 3-5 minutes as baseline treatment in both groups. Patients will be included based on inclusion and exclusion criteria. Assessment will be done by using NPRS and Oswestry disability Index Questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LBP for more than 3 months\n\nBoth male and females.\n\nAge between 20-50 years old.\n\nModerate to severe pain (VAS; 3-7)\n\nCurrently seeking care for LBP.\n\nExclusion Criteria:\n\n* Spinal surgery\n\nPregnancy\n\nProstatectomy\n\nEngaged in any sports activities\n\nAny evidence of nerve root compression'}, 'identificationModule': {'nctId': 'NCT06778694', 'briefTitle': 'Comparative Effects of Motor Control and Isolated Strengthening Lumbar Exercises on Functional Outcomes in Patients with Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Faisalabad'}, 'officialTitle': 'Comparative Effects of Motor Control and Isolated Strengthening Lumbar Exercises on Functional Outcomes in Patients with Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'ILEX MCE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Motor control exercises', 'interventionNames': ['Other: Motor control exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Isolated strengthening lumbar exercises', 'interventionNames': ['Other: Isolated strengthening lumbar exercises']}], 'interventions': [{'name': 'Motor control exercises', 'type': 'OTHER', 'description': 'Bridging Dead bug Plank Pelvic tilts Squatting and lunges', 'armGroupLabels': ['Group 1']}, {'name': 'Isolated strengthening lumbar exercises', 'type': 'OTHER', 'description': 'Child pose Mckenzie Lat pull down Russian twist', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hafiza Ayesha Aslam Muhammad Aslam', 'role': 'CONTACT', 'email': 'ayeshaaslam230800@gmail.com', 'phone': '03320628461'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Faisalabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hafiza Ayesha Aslam', 'investigatorFullName': 'Hafiza Ayesha Aslam', 'investigatorAffiliation': 'University of Faisalabad'}}}}