Low Back PainNCT01540617
The Neural Basis of Lumbosacral Proprioceptive Impairment in Recurrent Low Back Pain
An observational study of Low Back Pain, run by KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2012to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Leuven and surrounding area
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Proprioception, Postural control, Spine, Variability, MRI, Vibration, Brain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Persons with low back pain | Not described | |
| Healthy persons | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural changes in white matter pathways (3DTFE and DTI) (in individuals with recurrent non-specific low back pain compared to healthy controls)
Measured: One time point
Changes in resting state activity between individuals with recurrent non-specific low back pain and healthy controls)
Measured: One time point
Proprioceptive postural control (center of pressure displacement in response to muscle vibration)
Measured: One time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Responsible party
- Principal investigator, Simon Brumagne, KU Leuven
- Investigators
- Simon Brumagne, Professor, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540617
- Sponsor's protocol ID
- 2012_SBrumagne_MRIproprio
- Status last verified
- Apr 2014
- First submitted
- 23 Feb 2012
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 20824281Brumagne 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 18594876Brumagne 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural Basis of Lumbosacral Proprioceptive Impairment in Recurrent Low Back Pain
- ClinicalTrials.gov ID
- NCT01540617
- Acronym / sponsor ID
- 2012_SBrumagne_MRIproprio
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Proprioception, Postural control, Spine, Variability, MRI, Vibration, Brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 29 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persons with low back pain | – | – |
| Healthy persons | – | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Leuven and surrounding area
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Changes in resting state activity between individuals with recurrent non-specific low back pain and healthy controls)
Time frame: One time point
Proprioceptive postural control (center of pressure displacement in response to muscle vibration)
Time frame: One time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
- Background: PubMed 20824281Claeys 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.
- Background: PubMed 18594876Brumagne 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.
- Background: PubMed 18541428Brumagne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Brumagne, Professor principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01540617, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.