Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-03 @ 5:04 PM
Study NCT ID:
NCT03097718
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2017-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Central Proprioceptive Processing and Postural Control in LBP
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-04', 'studyFirstSubmitDate': '2017-01-26', 'studyFirstSubmitQcDate': '2017-03-27', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain activation during the processing of proprioceptive signals originating in the ankle muscles and lumbar paraspinal muscles', 'timeFrame': 'One time point, immediately after inclusion in the study', 'description': "Brain activation during the processing of proprioceptive signals originating in the ankle muscles (soleus muscle) and lumbar paraspinal muscles (multifidus muscles) is studied by applying muscle vibration to these muscles during fMRI. The test subjects participate in one scanning session, during which three fMRI runs with ankle muscle vibration and three fMRI runs with lumbar paraspinal muscles vibration are made in alternating order. Each fMRI run consists of three conditions: 'muscle vibration at 60 Hz' that stimulates muscle proprioceptors and vibrotactile skin receptors, 'muscle vibration at 20 Hz' that stimulates vibrotactile skin receptors (serves as a control condition) and 'rest'. During each fMRI run, the two 'vibration' conditions are presented three times during 18s-long blocks. Each' vibration' block is followed by a 18s-long 'rest' block."}, {'measure': 'Proprioceptive use during postural control', 'timeFrame': 'One time point, immediately after inclusion in the study', 'description': 'Mean center-of-pressure displacement in response to soleus muscle and/or multifidus muscle vibration (60 Hz, 0.5 mm) during upright standing on two support surfaces.\n\nCondition A: stable support surface:\n\n* Upright standing, vision occluded (20s) - bilateral soleus and multifidus muscle vibration (15s) - upright standing (20s)\n* Upright standing, vision occluded (20s) - bilateral soleus muscle vibration (15s) - upright standing (20s)\n* Upright standing, vision occluded (20s) - bilateral multifidus muscle vibration (15s) - upright standing (20s)\n\nCondition B: unstable support surface (Airex balance pad elite):\n\n* Upright standing, vision occluded (20s) - bilateral soleus and multifidus muscle vibration (15s) - upright standing (20s)\n* Upright standing, vision occluded (20s) - bilateral soleus muscle vibration (15s) - upright standing (20s)\n* Upright standing, vision occluded (20s) - bilateral multifidus muscle vibration (15s) - upright standing (20s)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'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': '25467548', 'type': 'BACKGROUND', 'citation': 'Claeys K, Dankaerts W, Janssens L, Pijnenburg M, Goossens N, Brumagne S. Young individuals with a more ankle-steered proprioceptive control strategy may develop mild non-specific low back pain. J Electromyogr Kinesiol. 2015 Apr;25(2):329-38. doi: 10.1016/j.jelekin.2014.10.013. Epub 2014 Oct 31.'}, {'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': '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.'}]}, 'descriptionModule': {'briefSummary': 'This project aims to elucidate neural correlates of proprioceptive deficits in patients with recurrent non-specific low back pain, by studying whether brain activation patterns during the processing of proprioceptive signals from the ankle muscles and lower back muscles are altered compared to healthy control subjects.', 'detailedDescription': 'Low back pain is a highly prevalent health condition, with a reported lifetime prevalence of up to 84% worldwide. Currently, it induces more disability than any other health condition, such as depression, diabetes, chronic obstructive pulmonary disease or other musculoskeletal disorders. Approximately 85% of all low back pain complaints are non-specific, meaning that the pain cannot be attributed to a recognizable specific pathology such as an infection or vertebral fracture. While many patients with low back pain recover within a month, a large number of patients report a recurrence within one year. Current treatment interventions often remain unsuccessful, which highlights the current lack of knowledge on the underlying mechanisms of non-specific low back pain.\n\nPostural control deficits have been identified as a key factor in the development and recurrence of non-specific low back pain. To achieve optimal postural control, the central nervous system needs to process, integrate and weigh proprioceptive signals from different body regions (e.g. ankle muscles and lower back muscles) with vestibular and visual inputs. Several studies have shown that patients with non-specific low back pain have a decreased ability to optimally weigh proprioceptive signals during standing, which leads to reduced postural robustness compared to pain-free individuals. More specifically, patients with low back pain dominantly rely more on proprioceptive signals from the ankle muscles and are not able to up-weigh proprioceptive signals from the lower back muscles when needed. This might be due to an impaired central processing of proprioceptive signals. However, up to now no studies have investigated central proprioceptive processing in patients with recurrent non-specific low back pain.\n\nTherefore, this project aims to elucidate whether patients with recurrent non-specific low back pain showed altered brain activation patterns during the processing of proprioceptive signals from the ankle muscles and lower back muscles compared to healthy controls, by applying local muscle vibration during functional magnetic resonance imaging (fMRI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Leuven and surrounding area', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria for individuals with recurrent non-specific low back pain:\n\n* Age: 20 - 50 years old\n* At least six months of low back pain with or without referred pain to the buttock or thigh\n* At least three episodes of disabling low back pain\n* A score of at least 14% on the Oswestry Disability Index\n* Willing to sign the informed consent\n* Meets specific criteria related to MRI-research\n\nInclusion Criteria for healthy individuals\n\n* Age: 20 - 50 years old\n* No history of low back pain\n* A score of 0% on the Oswestry Disability Index\n* Willing to sign the informed consent\n* Meets specific criteria related to MRI-research\n\nExclusion Criteria for both groups:\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's disease, multiple sclerosis, Stroke with sequelae\n* Radicular symptoms\n* Using strong opioid medication or antidepressants\n* Neck pain\n* Ankle problems"}, 'identificationModule': {'nctId': 'NCT03097718', 'briefTitle': 'Central Proprioceptive Processing and Postural Control in LBP', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Central Proprioceptive Processing and Postural Control in Individuals With and Without Recurrent Non-specific Low Back Pain', 'orgStudyIdInfo': {'id': '2016_SBrumagne_PropriocProcess'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-specific low back pain', 'description': 'Individuals with recurrent non-specific low back pain'}, {'label': 'Healthy control subjects', 'description': 'Healthy individuals without low back pain'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Katholieke Universiteit Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agentschap voor Innovatie door Wetenschap en Technologie', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Simon Brumagne', 'investigatorAffiliation': 'KU Leuven'}}}}