NCT03097718

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

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

Study Start

First participant enrolled

January 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

2.5 years

First QC Date

January 26, 2017

Last Update Submit

February 4, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    One time point, immediately after inclusion in the study

  • 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)

    One time point, immediately after inclusion in the study

Study Arms (2)

Non-specific low back pain

Individuals with recurrent non-specific low back pain

Healthy control subjects

Healthy individuals without low back pain

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 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
  • 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

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's disease, multiple sclerosis, Stroke with sequelae
  • Radicular symptoms
  • Using strong opioid medication or antidepressants
  • Neck pain
  • Ankle problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katholieke Universiteit Leuven

Leuven, 3000, Belgium

Location

Related Publications (4)

  • 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
  • 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.

    PMID: 25467548BACKGROUND
  • 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

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

January 26, 2017

First Posted

March 31, 2017

Study Start

January 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

February 5, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations