- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01540617
The Neural Basis of Lumbosacral Proprioceptive Impairment in Recurrent Low Back Pain
Low back pain (LBP) is a well known health problem in Western society that is significantly responsible for socio-economic problems like absenteeism and disability. The lifetime prevalence of LBP is 60-80% and approximately 85% of this LBP has a "non-specific" character whereby the underlying causes and risk factors cannot be demonstrated. While many people recover within a month, most individuals will have recurrence within a year with more severe symptoms. This might be due to insufficient knowledge of the underlying mechanisms. Impaired proprioception, the ability to discern body/limb positions and movements, may cause and maintain LBP shown by an altered postural control strategy. Specifically, patients with LBP rely more on proprioceptive signals from the ankles due to less reliable proprioceptive input of proximal segments. Moreover, they show a decreased variability in postural control and less postural robustness, while variability is a prerequisite for optimal functioning of biological systems. However, further clarification of the neural correlates is necessary. Deficits in proprioception, as found in a subgroup of patient with LBP, are associated with a decreased ability of the brain to process proprioceptive inputs.
The aim of this project is to clarify the central changes in individuals with recurrent non-specific low back pain and healthy controls. To evaluate these central changes MRI techniques (3DTFE, DTI and RS-fMRI) will be used. In addition, the association between central changes and postural control tasks will be evaluated.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Leuven, Belgium, 3000
- Katholieke Universiteit Leuven
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria persons with low back pain:
- Age: 20-50 year
- At least 6 months of low back pain with/without referred pain in buttock/thigh
- At least 3 episodes of disabling low back pain
- At least a score of 14% on the Oswestry Disability Index
- Willingness to sign the informed consent
- Met the MRI related requirements
Inclusion Criteria healthy persons:
- Age: 20-50 year
- No history of low back pain
- A score of 0% on the Oswestry Disability Index
- Willingness to sign the informed consent
- Met the MRI related requirements
Exclusion Criteria:
- History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant
- One of the following conditions: Parkinson, MS, Stroke with sequels....
- Radicular symptoms
- Not Dutch-speaking
- Strong opioids
- Neck pain
- Ankle problems
- Smoking
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Persons with low back pain
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Healthy persons
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Structural changes in white matter pathways (3DTFE and DTI) (in individuals with recurrent non-specific low back pain compared to healthy controls)
Time Frame: One time point
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One time point
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Changes in resting state activity between individuals with recurrent non-specific low back pain and healthy controls)
Time Frame: One time point
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One time point
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Proprioceptive postural control (center of pressure displacement in response to muscle vibration)
Time Frame: One time point
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One time point
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Simon Brumagne, Professor, KU Leuven
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012_SBrumagne_MRIproprio
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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