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CompletedNCT03097718Updated Feb 5, 2019

Central Proprioceptive Processing and Postural Control in LBP

An observational study in Low Back Pain, sponsored by KU Leuven. Completed at 1 site in Belgium. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-05.

Sponsored by KU Leuven · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
40
Ages
20 Years to 50 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

Postural 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.

Therefore, 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).

02

Conditions studied

  • Low Back Pain
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 40 is below the median of 100 across 357 observational studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Leuven and surrounding area

Inclusion Criteria for individuals with recurrent non-specific low back pain:

  • Age: 20 - 50 years old
  • At least six months of low back pain with or without referred pain to the buttock or thigh
  • At least three episodes of disabling low back pain
  • A score of at least 14% on the Oswestry Disability Index
  • Willing to sign the informed consent
  • Meets specific criteria related to MRI-research

Inclusion criteria

Inclusion Criteria for healthy individuals

  • Age: 20 - 50 years old
  • No history of low back pain
  • A score of 0% on the Oswestry Disability Index
  • Willing to sign the informed consent
  • Meets specific criteria related to MRI-research

Exclusion criteria

Exclusion Criteria for both groups:

  • History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant
  • One of the following conditions: Parkinson's disease, multiple sclerosis, Stroke with sequelae
  • Radicular symptoms
  • Using strong opioid medication or antidepressants
  • Neck pain
  • Ankle problems
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • Non-specific low back pain

    Individuals with recurrent non-specific low back pain

  • Healthy control subjects

    Healthy individuals without low back pain

06

What researchers measure

Primary outcomes

  1. Brain activation during the processing of proprioceptive signals originating in the ankle muscles and lumbar paraspinal muscles

    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.

    Time frame: One time point, immediately after inclusion in the study

  2. Proprioceptive use during postural control

    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. Condition A: stable support surface: * Upright standing, vision occluded (20s) - bilateral soleus and multifidus muscle vibration (15s) - upright standing (20s) * Upright standing, vision occluded (20s) - bilateral soleus muscle vibration (15s) - upright standing (20s) * Upright standing, vision occluded (20s) - bilateral multifidus muscle vibration (15s) - upright standing (20s) Condition B: unstable support surface (Airex balance pad elite): * Upright standing, vision occluded (20s) - bilateral soleus and multifidus muscle vibration (15s) - upright standing (20s) * Upright standing, vision occluded (20s) - bilateral soleus muscle vibration (15s) - upright standing (20s) * Upright standing, vision occluded (20s) - bilateral multifidus muscle vibration (15s) - upright standing (20s)

    Time frame: One time point, immediately after inclusion in the study

07

Study locations

1 site
  • Katholieke Universiteit Leuven
    Leuven, 3000, Belgium
08

References and documents

Publications

  • 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. PubMed 18541428 ↗
  • 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. PubMed 25467548 ↗
  • 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. PubMed 20824281 ↗
  • 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. PubMed 18594876 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03097718
Lead sponsor
KU Leuven
Collaborators
Agentschap voor Innovatie door Wetenschap en Technologie
Responsible party
Simon Brumagne (Professor, KU Leuven) — Principal investigator
First posted
Mar 31, 2017
Start date
Jan 2016
Primary completion
Jul 2018
Completion
Jul 2018
Last update
Feb 5, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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