Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-27 @ 9:43 AM
Study NCT ID:
NCT00454792
Status:
COMPLETED
Last Update Posted:
2011-09-26
First Post:
2007-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation of Patients With Modic Changes in the Lumbar Spine
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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-23', 'studyFirstSubmitDate': '2007-03-30', 'studyFirstSubmitQcDate': '2007-03-30', 'lastUpdatePostDateStruct': {'date': '2011-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure is actual LBP, as measured with an "11 point box scale".', 'timeFrame': '10 weeks and 12 months'}], 'secondaryOutcomes': [{'measure': 'General Health, as measured with the EQ-5D (EuroQol)', 'timeFrame': '10 weeks and 12 months'}, {'measure': 'General improvement, as measured with two global instruments a 7-point transition question and an assessment score consisting of a "bothersomeness index"', 'timeFrame': '10 weeks and 12 months'}, {'measure': 'Physical functions measured with "Roland Morris Disability Questionnaire"', 'timeFrame': '10 weeks and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Low back pain', 'Modic changes'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '22376791', 'type': 'DERIVED', 'citation': 'Jensen RK, Leboeuf-Yde C, Wedderkopp N, Sorensen JS, Manniche C. Rest versus exercise as treatment for patients with low back pain and Modic changes. A randomized controlled clinical trial. BMC Med. 2012 Feb 29;10:22. doi: 10.1186/1741-7015-10-22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare patients with low back pain (LBP) and Modic Changes from The Backcenter Funen, Ringe:\n\n1. To compare the effect of two types of non-operative treatments:\n\n A. exercise and advice to be physically active\n\n B. restitution and advice not to overload the spine\n2. To investigate if the results of the treatment are influenced by gender, age, smoking, and physical load.', 'detailedDescription': 'The clinical experience is that many patients with Modic changes have relatively severe and persistent LBP, which typically appears to be resistant to treatment. Furthermore, a retrospective study at The Backcenter Funen, Ringe, shows that patients with MC fail to improve engaging physical activity. This is unfortunate, because the typical rehabilitation for patients with persistent LBP is back exercises and information about keeping physically active. This means that this relatively large subgroup of patients with Modic changes probably does not improve with the rehabilitation tools used today.\n\nA randomised controlled trial has therefore been designed to study the specific subgroup of patients with Modic changes. In this study we will compare the present "state-of-the art" rehabilitation approach to persistent LBP (namely to exercise and keep active) with a new concept (restitution). The justification for this is that restitution reduces mechanical stress on the vertebrae and therefore would allow heeling of the possible micro fractures in Modic changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPrimary inclusion criteria for receiving MRI\n\n* The patient must have LBP with a current duration of 3 - 12 month.\n* The patient must have an actual pain intensity ≥4 on numerical pain rating scale from 0-10.\n\nSecondary inclusion criteria for receiving MRI\n\n* The patient must speak and understand Danish.\n* The patient must be between 18-60 years of age.\n* The patient must be willing to participate in the project. Inclusions criterium for the project\n* There must be an MRI showing MC in the lumbar spine.\n\nExclusion Criteria:\n\n* The patient is unable to go through with the project because of other physical or mental disorder.\n* The patient is pregnant.\n* The patient is referred to operation.'}, 'identificationModule': {'nctId': 'NCT00454792', 'briefTitle': 'Rehabilitation of Patients With Modic Changes in the Lumbar Spine', 'organization': {'class': 'OTHER', 'fullName': 'The Back Research Center, Denmark'}, 'officialTitle': 'Rehabilitation of Patients With Modic Changes in the Lumbar Spine - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'VF-20060111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise and advise to stay active', 'description': 'The exercise group received exercises for the stabilising muscles in the low back and abdomen together with dynamic exercises, exercises for postural instability and light physical fitness training.', 'interventionNames': ['Other: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Rest and use of flexible lumbar belt', 'description': 'The rest group was instructed to avoid hard physical activity and to rest twice daily for one hour, by lying down', 'interventionNames': ['Other: Restitution']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Back exercise: At home every day. In groups once a week. Duration 10 weeks.', 'armGroupLabels': ['Exercise and advise to stay active']}, {'name': 'Restitution', 'type': 'OTHER', 'description': 'Restitution: At home 2 times one hour. Meetings every 2 weeks. Duration 10 weeks.', 'armGroupLabels': ['Rest and use of flexible lumbar belt']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5500', 'city': 'Middelfart', 'country': 'Denmark', 'facility': 'Spine Centre of Southern Denmark', 'geoPoint': {'lat': 55.50591, 'lon': 9.73054}}], 'overallOfficials': [{'name': 'Claus Manniche, Prof.Dr.Med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Spine Centre of Southern Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Back Research Center, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Velux Fonden', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc', 'investigatorFullName': 'Rikke Krüger Jensen', 'investigatorAffiliation': 'The Back Research Center, Denmark'}}}}