NCT01540617

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

2 years

First QC Date

February 23, 2012

Last Update Submit

April 11, 2014

Conditions

Keywords

Low back painProprioceptionPostural controlSpineVariabilityMRIVibrationBrain

Outcome Measures

Primary Outcomes (3)

  • 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

  • Changes in resting state activity between individuals with recurrent non-specific low back pain and healthy controls)

    One time point

  • Proprioceptive postural control (center of pressure displacement in response to muscle vibration)

    One time point

Study Arms (2)

Persons with low back pain

Healthy persons

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Leuven and surrounding area

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katholieke Universiteit Leuven

Leuven, 3000, Belgium

Location

Related Publications (3)

  • 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: 20824281BACKGROUND
  • 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: 18594876BACKGROUND
  • 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: 18541428BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Simon Brumagne, Professor

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

February 23, 2012

First Posted

February 29, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations