Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT01505595
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2012-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proprioceptive Training and 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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2012-01-04', 'studyFirstSubmitQcDate': '2012-01-05', 'lastUpdatePostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proprioceptive postural control', 'timeFrame': '12 weeks', 'description': 'Center of pressure displacement (force plate) in standing in response to local muscle vibration on ankle and back muscles to specifically detect the role of proprioception in postural control.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Proprioceptive Training', 'Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '20824281', 'type': 'BACKGROUND', 'citation': 'Claeys K, Brumagne S, Dankaerts W, Kiers H, Janssens L. Decreased variability in postural control strategies in young people with non-specific low back pain is associated with altered proprioceptive reweighting. Eur J Appl Physiol. 2011 Jan;111(1):115-23. doi: 10.1007/s00421-010-1637-x. Epub 2010 Sep 8.'}, {'pmid': '21533851', 'type': 'BACKGROUND', 'citation': 'Johanson E, Brumagne S, Janssens L, Pijnenburg M, Claeys K, Paasuke M. The effect of acute back muscle fatigue on postural control strategy in people with and without recurrent low back pain. Eur Spine J. 2011 Dec;20(12):2152-9. doi: 10.1007/s00586-011-1825-3. Epub 2011 May 1.'}, {'pmid': '20393397', 'type': 'BACKGROUND', 'citation': 'Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3.'}, {'pmid': '18594876', 'type': 'BACKGROUND', 'citation': 'Brumagne S, Janssens L, Knapen S, Claeys K, Suuden-Johanson E. Persons with recurrent low back pain exhibit a rigid postural control strategy. Eur Spine J. 2008 Sep;17(9):1177-84. doi: 10.1007/s00586-008-0709-7. Epub 2008 Jul 2.'}, {'pmid': '18541428', 'type': 'BACKGROUND', 'citation': 'Brumagne S, Janssens L, Janssens E, Goddyn L. Altered postural control in anticipation of postural instability in persons with recurrent low back pain. Gait Posture. 2008 Nov;28(4):657-62. doi: 10.1016/j.gaitpost.2008.04.015. Epub 2008 Jun 9.'}, {'pmid': '26795132', 'type': 'DERIVED', 'citation': 'Janssens L, Brumagne S, Claeys K, Pijnenburg M, Goossens N, Rummens S, Depreitere B. Proprioceptive use and sit-to-stand-to-sit after lumbar microdiscectomy: The effect of surgical approach and early physiotherapy. Clin Biomech (Bristol). 2016 Feb;32:40-8. doi: 10.1016/j.clinbiomech.2015.12.011. Epub 2016 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'Proprioceptive weighting changes may explain differences in postural control performance. Deficits in proprioception are found in a subgroup of patients with low back pain.\n\nThe aim of the study is to clarify whether proprioceptive training has a positive effect on proprioceptive postural control in individuals with recurrent low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria individuals with low back pain:\n\n* Age: 18-45 years old\n* At least 1 year of low back pain with/without referred pain in buttock/thigh\n* At least 3 episodes of disabling low back pain\n* At least a score of 20% on the Oswestry Disability Index\n* Willingness to sign the informed consent\n\nExclusion Criteria:\n\n* History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant\n* One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy\n* Radicular symptoms\n* Not Dutch-speaking\n* Strong opioids\n* Neck pain\n* Smoking history'}, 'identificationModule': {'nctId': 'NCT01505595', 'briefTitle': 'Proprioceptive Training and Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'orgStudyIdInfo': {'id': '2012_SBrumagne_PT-LBP'}, 'secondaryIdInfos': [{'id': '1.5.104.03, G.0674.09', 'type': 'OTHER_GRANT', 'domain': 'Research Foundation Flanders (FWO)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proprioceptive training', 'interventionNames': ['Other: Proprioceptive training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham proprioceptive training', 'interventionNames': ['Other: Sham proprioceptive training']}], 'interventions': [{'name': 'Proprioceptive training', 'type': 'OTHER', 'description': '12 weeks', 'armGroupLabels': ['Proprioceptive training']}, {'name': 'Sham proprioceptive training', 'type': 'OTHER', 'description': 'Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 10% Pi,max', 'armGroupLabels': ['Sham proprioceptive training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Katholieke Universiteit Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Simon Brumagne, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}, {'name': 'Thierry Troosters, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}, {'name': 'Roeland Lysens, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}, {'name': 'Peter Van Wambeke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr. Simon Brumagne', 'investigatorFullName': 'Simon Brumagne', 'investigatorAffiliation': 'KU Leuven'}}}}