Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-27 @ 10:04 AM
Study NCT ID:
NCT01567566
Status:
UNKNOWN
Last Update Posted:
2012-03-30
First Post:
2012-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy Study of Exercise Rehabilitation on Pain and Disability for Patients With Non-specific 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-28', 'studyFirstSubmitDate': '2012-03-27', 'studyFirstSubmitQcDate': '2012-03-28', 'lastUpdatePostDateStruct': {'date': '2012-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain intensity measured by a 10cm visual analogue scale', 'timeFrame': '6 weeks', 'description': 'Measures will be taken at baseline, at 3wk follow up, and at 6wk follow up to ivestigate the changes at mid point and following the exercise intervention'}], 'secondaryOutcomes': [{'measure': 'Change in biomechanical variables using an eight camera motion capture system', 'timeFrame': '6 weeks', 'description': 'Measures will be taken at baseline and at 6wk follow up to ivestigate the changes at mid point and following the exercise intervention'}, {'measure': 'Change in disability score as measured by the Oswestry Disability Questionnaire', 'timeFrame': '6 weeks', 'description': 'Measures will be taken at baseline, at 3wk follow up, and at 6wk follow up to ivestigate the changes at mid point and following the exercise intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['home based daily exercise program', 'local lumbopelvic stabilizer muscles', 'hip stabilizer muscles', 'real time ultrasound imaging'], 'conditions': ['Low Back Pain, Mechanical']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the efficacy of two different exercise programs for the reduction of pain and disability in a specific subgroup of NSLBP patients and aims to investigate the additive effect of hip stabilization exercises. The investigators hypothesize that the combined local (segmental) stabilizer and hip stabilizer program (T2) will be more effective in reducing pain and disability in NSLBP patients compared to the local (segmental) stabilizer program (T1).', 'detailedDescription': 'The secondary objective of this study is to measure the changes in lumbopelvic and hip mechanics for both treatment groups following completion of the exercise programs. We hypothesize that there will be differences observed between groups following the 6wk rehabilitation programs, and that only the group completing the combined local (segmental) stabilizer and hip stabilizer strengthening program (T2) will demonstrate significant differences in mechanics compared to baseline testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-65 years old\n* Unilateral or bilateral NSLBP symptoms for a minimum of 6 weeks\n* Current symptoms rated at least a 5/10 on a scaled from 0-10\n\nExclusion Criteria:\n\n* Symptoms 'red flags' for underlying pathological conditions such as bowel and/or bladder problems, radicular symptoms, night pain\n* Scoliosis\n* Neurological impairment, discogenic pathology, vestibular disorder\n* Pregnancy or within 1 year of giving birth\n* Previous or ongoing complications from lower extremity injury or surgery in the past year\n* Previous surgery to the lumbar spine or hip\n* Use of any radiological interventions or injections such as prolotherapy, corticosteroid, or nerve block in the past 3 months"}, 'identificationModule': {'nctId': 'NCT01567566', 'acronym': 'LBP-RCT', 'briefTitle': 'An Efficacy Study of Exercise Rehabilitation on Pain and Disability for Patients With Non-specific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Running Injury Clinic'}, 'officialTitle': 'The Effect of Hip Stabilizer Muscle Strengthening on Pain and Disability for Patients With Non-specific Low Back Pain: an Outcome-based Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RIC-WCB-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Local lumbopelvic stabilizers', 'interventionNames': ['Other: exercise rehabilitation program']}, {'type': 'EXPERIMENTAL', 'label': 'Local lumbopelvic plus hip stabilizers', 'interventionNames': ['Other: exercise rehabilitation program']}], 'interventions': [{'name': 'exercise rehabilitation program', 'type': 'OTHER', 'otherNames': ['Core stabilization exercises', 'Hip stabilization exercises'], 'description': '6 week home based exercise rehabilitation program with 6 weekly supervised sessions using real time ultrasound as biofeedback to augment training in both treatment arms', 'armGroupLabels': ['Local lumbopelvic plus hip stabilizers', 'Local lumbopelvic stabilizers']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 1N4', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jill Baxter, BSc', 'role': 'CONTACT', 'email': 'jbaxter@ucalgary.ca', 'phone': '403 220 7411'}, {'name': 'Karen D Kendall, PhD Cand.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Reed Ferber, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Running Injury Clinic', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'Jill Baxter, BSc', 'role': 'CONTACT', 'email': 'jbaxter@ucalgary.ca', 'phone': '403 220 7411'}], 'overallOfficials': [{'name': 'Karen D Kendall, MKin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Running Injury Clinic, Faculty of Kinesiology, University of Calgary'}, {'name': 'Reed Ferber, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Running Injury Clinic, Faculty of Kinesiology, University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Running Injury Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'WCB Alberta', 'class': 'UNKNOWN'}, {'name': 'Alberta Health services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Karen D. Kendall', 'investigatorAffiliation': 'Running Injury Clinic'}}}}