The Neural Basis of Lumbosacral Proprioceptive Impairment in Recurrent Low Back Pain

This study has been completed.
Sponsor:
Collaborator:
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by (Responsible Party):
Simon Brumagne, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01540617
First received: February 23, 2012
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition
Low Back Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Neural Basis of Lumbosacral Proprioceptive Impairment in Recurrent Low Back Pain

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Changes in resting state activity between individuals with recurrent non-specific low back pain and healthy controls) [ Time Frame: One time point ] [ Designated as safety issue: No ]
  • Proprioceptive postural control (center of pressure displacement in response to muscle vibration) [ Time Frame: One time point ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: April 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Persons with low back pain
Healthy persons

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Leuven and surrounding area

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540617

Locations
Belgium
Katholieke Universiteit Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Agentschap voor Innovatie door Wetenschap en Technologie
Investigators
Principal Investigator: Simon Brumagne, Professor Katholieke Universiteit Leuven
  More Information

Publications:
Responsible Party: Simon Brumagne, Prof. dr., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01540617     History of Changes
Other Study ID Numbers: 2012_SBrumagne_MRIproprio
Study First Received: February 23, 2012
Last Updated: April 11, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by Katholieke Universiteit Leuven:
Low back pain
Proprioception
Postural control
Spine
Variability
MRI
Vibration
Brain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014