Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-30 @ 5:27 AM
Study NCT ID:
NCT01854892
Status:
COMPLETED
Last Update Posted:
2017-05-12
First Post:
2013-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053685', 'term': 'Laser Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-11', 'studyFirstSubmitDate': '2013-05-03', 'studyFirstSubmitQcDate': '2013-05-13', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in numerical pain rating score', 'timeFrame': '48 hours post 3 week intervention'}, {'measure': 'Change in disability score', 'timeFrame': '48 hours post 3 week intervention', 'description': 'Roland Morris disability questionnaire'}], 'secondaryOutcomes': [{'measure': 'Change in score on PROMIS Pain Behavior Survey', 'timeFrame': '48 hours post 3 week intervention', 'description': 'This survey was developed by the NIH to provide reliable and valid measures of pain behavior. We will exam the change in scores on this survey from visit 2 (initial testing session) to visit 8(48 hours post 3 week intervention)'}, {'measure': 'Change in scores on PROMIS pain interference survey', 'timeFrame': '48 hours post 3 week interventions', 'description': 'This survey was developed by the NIH to provide reliable and valid measures of pain interference. We will exam the change in scores on this survey from visit 2 (initial testing session) to visit 8(48 hours post 3 week intervention)'}, {'measure': 'Change in scores on PROMIS pain intensity survey', 'timeFrame': '48 hours post 3 week intervention', 'description': 'This survey was developed by the NIH to provide reliable and valid measures of pain intensity. We will exam the change in scores on this survey from visit 2 (initial testing session) to visit 8(48 hours post 3 week intervention)'}, {'measure': 'Change in scores on PROMIS physical function survey', 'timeFrame': '48 hours post 3 week intervention', 'description': 'This survey was developed by the NIH to provide reliable and valid measures of physical function. We will exam the change in scores on this survey from visit 2 (initial testing session) to visit 8(48 hours post 3 week intervention).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['low back pain', 'manipulation', 'laser therapy', 'osteopathic', 'chiropractic', 'mobilization', 'muscle energy', 'physical therapy', 'muscle', 'spine', 'adjustment', 'rehabilitation'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '33828171', 'type': 'DERIVED', 'citation': 'Stamenkovic A, Clark BC, Pidcoe PE, van der Veen SM, France CR, Russ DW, Kinser PA, Thomas JS. Distinguishing chronic low back pain in young adults with mild to moderate pain and disability using trunk compliance. Sci Rep. 2021 Apr 7;11(1):7592. doi: 10.1038/s41598-021-87138-6.'}, {'pmid': '32756930', 'type': 'DERIVED', 'citation': 'Thomas JS, Clark BC, Russ DW, France CR, Ploutz-Snyder R, Corcos DM; RELIEF Study Investigators. Effect of Spinal Manipulative and Mobilization Therapies in Young Adults With Mild to Moderate Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2012589. doi: 10.1001/jamanetworkopen.2020.12589.'}, {'pmid': '29792940', 'type': 'DERIVED', 'citation': 'Clark BC, Russ DW, Nakazawa M, France CR, Walkowski S, Law TD, Applegate M, Mahato N, Lietkam S, Odenthal J, Corcos D, Hain S, Sindelar B, Ploutz-Snyder RJ, Thomas JS. A randomized control trial to determine the effectiveness and physiological effects of spinal manipulation and spinal mobilization compared to each other and a sham condition in patients with chronic low back pain: Study protocol for The RELIEF Study. Contemp Clin Trials. 2018 Jul;70:41-52. doi: 10.1016/j.cct.2018.05.012. Epub 2018 May 21.'}]}, 'descriptionModule': {'briefSummary': 'Low back pain (LBP) is one of the most common reasons for seeking medical care and accounts for over 3.7 million physician visits/year in the U.S. alone. Ninety percent of adults will experience low back pain in their lifetime, 50% will experience recurrent LBP, and 10% will develop chronic pain and related disability.\n\nWhile there is growing evidence for the clinical effectiveness of alternative and complementary therapies to treat low back pain, little is known on the physiologic consequences and effects of these treatments. Further, additional data is needed to understand how these different treatment techniques effect clinical changes in pain and disability. The lack of empirical data hinders acceptance by the wider scientific and health-care communities, and it also limits the development of rational strategies for using alternative and complementary therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Report history consistent with chronic low back pain\n* Average pain intensity at least mild when assessed with a numerical pain scale\n* At least mild disability when assessed with a questionnaire\n* Meets criteria for clinical prediction rule\n\nExclusion Criteria:\n\n* A history of certain neurological, cardiorespiratory, and musculoskeletal disorders\n* Have active cancer or be blind\n* Report recent use of certain medications and treatments\n* Report being pregnant, lactating, or that she anticipates becoming pregnant in the next 3-months\n* Have too high body mass or unexplained weight loss\n* Have clinical depression\n* Have pending litigation related to the low back pain or are receiving any type of disability services\n* Current drug or alcohol use that would interfere with adherence to study requirements'}, 'identificationModule': {'nctId': 'NCT01854892', 'briefTitle': 'The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function', 'organization': {'class': 'OTHER', 'fullName': 'Ohio University'}, 'officialTitle': 'The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function', 'orgStudyIdInfo': {'id': 'AT006978'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manipulation', 'description': 'Spinal manipulation', 'interventionNames': ['Other: Manipulation']}, {'type': 'EXPERIMENTAL', 'label': 'Mobilization', 'description': 'Spinal mobilization', 'interventionNames': ['Other: Mobilization']}, {'type': 'EXPERIMENTAL', 'label': 'Laser Therapy', 'description': 'Cold laser therapy', 'interventionNames': ['Other: Laser Therapy']}], 'interventions': [{'name': 'Manipulation', 'type': 'OTHER', 'description': 'High velocity short amplitude thrust spinal manipulation applied to the lumbar spine.', 'armGroupLabels': ['Manipulation']}, {'name': 'Mobilization', 'type': 'OTHER', 'description': 'Static isometric contractions of the lumbar spine to induce spinal mobilization', 'armGroupLabels': ['Mobilization']}, {'name': 'Laser Therapy', 'type': 'OTHER', 'description': 'Cold laser applied to the paravertebral muscles in the lumbar region', 'armGroupLabels': ['Laser Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45701', 'city': 'Athens', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio University', 'geoPoint': {'lat': 39.32924, 'lon': -82.10126}}], 'overallOfficials': [{'name': 'James S Thomas, Ph.D., PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio University'}, {'name': 'Brian C Clark, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'James Thomas', 'investigatorAffiliation': 'Ohio University'}}}}