Low Back PainNCT03097718
Central Proprioceptive Processing and Postural Control in LBP
An observational study of Low Back Pain, run by KU Leuven at 1 site in Belgium.
Trial 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 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
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2016to Jul 2018
- 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 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
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's disease, multiple sclerosis, Stroke with sequelae
- Radicular symptoms
- Using strong opioid medication or antidepressants
- Neck pain
- Ankle problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central Proprioceptive Processing and Postural Control in Individuals With and Without Recurrent Non-specific Low Back Pain
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).
- Conditions
- Low Back Pain
- 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 |
|---|---|---|
| Non-specific low back pain | Individuals with recurrent non-specific low back pain | |
| Healthy control subjects | Healthy individuals without low back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: One time point, immediately after inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study startJan 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097718
- Sponsor's protocol ID
- 2016_SBrumagne_PropriocProcess
- Status last verified
- Feb 2019
- First submitted
- 26 Jan 2017
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 18541428Claeys 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 25467548Claeys 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 18594876
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Proprioceptive Processing and Postural Control in Individuals With and Without Recurrent Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT03097718
- Acronym / sponsor ID
- 2016_SBrumagne_PropriocProcess
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Study start
- Jan 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 31 Mar 2017 (actual)
- 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.
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.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-specific low back pain | – | –Individuals with recurrent non-specific low back pain |
| Healthy control subjects | – | –Healthy individuals without low back pain |
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 (5 listed)
- 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
Key exclusion criteria (6 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's disease, multiple sclerosis, Stroke with sequelae
- Radicular symptoms
- Using strong opioid medication or antidepressants
- Neck pain
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
Brain activation during the processing of proprioceptive signals originating in the ankle muscles and lumbar paraspinal muscles
Time frame: One time point, immediately after inclusion in the study
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.
Proprioceptive use during postural control
Time frame: One time point, immediately after inclusion in the study
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)
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 5 Feb 2019.
- 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.
- Background: PubMed 25467548Claeys 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.
- 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 5 inclusion and 6 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 5 Feb 2019. 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?
Brain activation during the processing of proprioceptive signals originating in the ankle muscles and lumbar paraspinal muscles (time frame: One time point, immediately after inclusion in the study). The study lists 2 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 NCT03097718, which also lists 4 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 5 Feb 2019.