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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01540617
Other study ID # 2012_SBrumagne_MRIproprio
Secondary ID
Status Completed
Phase N/A
First received February 23, 2012
Last updated April 11, 2014
Start date April 2012
Est. completion date April 2014

Study information

Verified date April 2014
Source Katholieke Universiteit Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 50 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium Katholieke Universiteit Leuven Leuven

Sponsors (2)

Lead Sponsor Collaborator
Katholieke Universiteit Leuven Agentschap voor Innovatie door Wetenschap en Technologie

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Structural changes in white matter pathways (3DTFE and DTI) (in individuals with recurrent non-specific low back pain compared to healthy controls) One time point No
Primary Changes in resting state activity between individuals with recurrent non-specific low back pain and healthy controls) One time point No
Primary Proprioceptive postural control (center of pressure displacement in response to muscle vibration) One time point No
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