Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT02222935
Status:
UNKNOWN
Last Update Posted:
2014-08-22
First Post:
2014-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Balance Training in Chronic Low Back Pain Patients
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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-21', 'studyFirstSubmitDate': '2014-08-20', 'studyFirstSubmitQcDate': '2014-08-21', 'lastUpdatePostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Starr Edward Balance Test', 'timeFrame': 'Baseline, 2 weeks'}], 'secondaryOutcomes': [{'measure': 'Berg Balance Scale', 'timeFrame': 'Baseline, 2 weeks'}, {'measure': 'Visual Analogue score', 'timeFrame': 'Baseline, 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Balance training', 'low back pain', 'balance test', 'routine back exercise'], 'conditions': ['Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Balance problems are addressed in low back pain patients. Dearth of literature available to prove core strengthening or any form of back exercises improving functional outcomes or balance in chronic back pain patients. No studies focus on balance training in improving balance of low back pain patients. The authors are conducting a randomised trial comparing balance exercises and routine back exercise program in improving pain, functional outcomes and balance of the patients', 'detailedDescription': 'Background: Balance deficits are common in low back pain. Current literature fail to prove the effectiveness of routine back exercises in improving balance of back pain patients. No study has concentrated on balance training in back pain patients.\n\nObjective: Compare balance exercises and routine back exercises in improving balance and other functional outcomes.\n\nProcedure: Back pain patients attending physiotherapy department of tertiary care teaching hospitals will be recruited voluntarily. Randomised to either balance and routine program based on simple lottery method. Balance training comprises of 5 exercises - single leg squats, dead lift, single leg raises, lateral step-ups and forward reach outs. Routine back exercises includes 5 sets - pelvic bridges, dynamic dead bug, prone planks, situps, lateral planks. 10Repetition Maximum, 2 Sets/ day, five days a week, 2 weeks. Baseline balance (star Edward, berg balance) and functional test (sit to stand) and pain (Visual analogue score) and post 2 weeks outcome scores will be analysed through paired and unpaired for between and within groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non specific low back pain diagnosed by orthopedical surgeon or physiatrist\n* Both genders\n* Age 25 - 45 years (to avoid age related balance deficit)\n* Should have balance deficit percentage (\\> 20%) through balance assessment scale\n\nExclusion Criteria:\n\n* H/O Benign Paroxysmal Positional Vertigo\n* Neuromuscular disorders(Stroke, Polio, Potts spine, spinal stenosis) affecting balance\n* any form of ear infection\n* Recent ear, nose, throat surgery\n* Recent surgery in abdomen, thorax, head (\\< 2 years)\n* Recent lower limb surgeries, injuries (\\< 6 months)\n* Any form of walking aids (cane, walker)'}, 'identificationModule': {'nctId': 'NCT02222935', 'acronym': 'CLB', 'briefTitle': 'Effectiveness of Balance Training in Chronic Low Back Pain Patients', 'organization': {'class': 'OTHER', 'fullName': 'PSG Hospitals'}, 'officialTitle': 'Effectiveness of Balance Training Over Routine Back Exercise in Improving Functional Outcomes of Chronic Low Back Pain Patients', 'orgStudyIdInfo': {'id': 'PSG02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Balance exercise training', 'description': 'Balance exercise training - thrice week, 2 weeks, 10 repetition Maximum/ set, 2 sets', 'interventionNames': ['Behavioral: Balance Exercise Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine Back exercise Program', 'description': 'Routine Back exercise Program - 10 Repetition Maximum / set, 2 sets, three times weekly, 2 weeks', 'interventionNames': ['Behavioral: Routine Back exercise program']}], 'interventions': [{'name': 'Balance Exercise Training', 'type': 'BEHAVIORAL', 'description': 'Balance exercise - 5 type (single leg squat, dead lift, step ups, forward reaches), 10 Repetition Maximum, 2 sets, five times a week and 2 weeks', 'armGroupLabels': ['Balance exercise training']}, {'name': 'Routine Back exercise program', 'type': 'BEHAVIORAL', 'description': 'Back strengthening 5 exercises - pelvic bridges, prone plank, side plank, dead bug and prone lift ups, 10 Repetition Maximum, 2 sets, five times a week, 2 weeks', 'armGroupLabels': ['Routine Back exercise Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '641004', 'city': 'Coimbatore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'PSG Hospitals, Department of Physical Medicine Rehabilitation', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}], 'overallOfficials': [{'name': 'Pavita Devi, BPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Senior Physiotherapist'}, {'name': 'Baskaran Chandrasekaran, MPT', 'role': 'STUDY_CHAIR', 'affiliation': 'Senior Physiotherapist'}, {'name': 'Sumathi Muraleetharan, BPT', 'role': 'STUDY_CHAIR', 'affiliation': 'Senior Physiotherpist'}, {'name': 'Ramamoorthy V Dr, MD PMR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of The Department, PMR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskaran Chandrasekaran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Physiotherapist', 'investigatorFullName': 'Baskaran Chandrasekaran', 'investigatorAffiliation': 'PSG Hospitals'}}}}