Low Back PainNCT03255616
Low Back Pain: Unveiling the Contribution of Motor Control Adaption Using Biomechanical Modeling and Neuroimaging
A study testing mechanical stimulation and vibrotactile stimulation in people with Low Back Pain, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
This project aims to reveal the potential sensorimotor reorganization of sensory input in low back pain patients and its association with different motor control strategies in LBP. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- mechanical stimulation and vibrotactile stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2019to 17 Jan 2023
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 60
- Written informed consent after being informed
- Aged between 18 and 60
- Low back pain for more than 1 week
Who cannot join
- Consumption of alcohol, drugs, analgesics within the last 24 h
- Pregnancy
- acute and/or low recurrent back pain within the last 3 months
- Prior spine surgery
- Other chronic pain condition
- history of psychiatric or neurological disorders
Show all 15Show fewer
- MR-contraindications
- Body mass index (BMI) > 30 kg/m2
- Consumption of alcohol, drugs, analgesics within the last 24 h
- Pregnancy
- Specific causes for the back pain (ruled out by the clinician)
- Prior spine surgery
- History of psychiatric or neurological disorders
- MR-contraindications
- Body mass index (BMI) > 30 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
This project aims to reveal the potential sensorimotor reorganization of sensory input in low back pain patients and its association with different motor control strategies in LBP.
Read the detailed description
Background: Low back pain (LBP) is a major health issue. Treatment of chronic LBP is still a major challenge due to a lack of pathophysiological understanding. Thus, understanding LBP pathophysiology is a research priority. Adaptions of motor control likely play a significant role in chronic or recurrent LBP because motor control is crucial for spine posture, stability and movement. Different motor adaption strategies exist across individuals with LBP and two phenotypes representing the opposite ends of a spectrum have been suggested; i.e. "tight" control and "loose" control over trunk movement. The former would be associated with reduced trunk motor variability, the later with increased trunk motor variability. This conceptual framework is very useful to explain maintenance and aggravating of LBP because motor control adaptations are expected to have long-term consequences, such as increased spinal tissue loading, associated with degeneration of intervertebral discs and other tissues. Several knowledge gaps need to be addressed to test the validity of this framework: 1) Do loose/tight control phenotypes indeed exist and/or do other motor control adaption strategies exist? 2) Is reduced/altered paraspinal proprioceptive input associated with LBP related to neuroplastic cortical changes, thereby affecting the organizational structure in sensorimotor cortices and top-down trunk motor control? 3) Do psychological factors influence the organizational structure in sensorimotor cortices and motor control strategies? To address these knowledge gaps, the objectives of the current project are: I) To establish motor control phenotypes in LBP. Proprioceptive weighting and biomechanical assessment of dynamic movement tasks, including subject-specific spine kinematic variability and its relationship to pain duration, negative pain-related cognitions, segmental loadings and paraspinal muscle forces, will be performed. II) To test whether cortical proprioceptive maps differ between healthy subjects and patients with LBP. Brain activation in response to thoracolumbar vibrotactile stimulation will be interrogated using functional magnetic resonance imaging data and univariate and multivariate analysis based on machine learning. III) To test whether proprioceptive maps demonstrate a relationship to spine kinematic patterns, pain duration and negative pain-related cognitions in LBP patients.
- Conditions
- Low Back Pain
- Being tested
- mechanical stimulation, vibrotactile stimulation
- 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.
mechanical stimulationOther
mechanical non-painful low- and high pressure stimuli to thoracolumbar segments of healthy subjects and low back pain patients
vibrotactile stimulationOther
non-painful vibrotactile stimulation within a frequency range between 20-150Hz to thoracolumbar segments of healthy subjects and low back pain patients
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | Spine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation Receives: Other: mechanical stimulation; Other: vibrotactile stimulation |
| Low back pain patients | Experimental | Spine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation Receives: Other: mechanical stimulation; Other: vibrotactile stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygenation level dependent (BOLD) responses
supraspinal BOLD responses induced by mechanical and vibrotactile stimulations of the back recorded by means of functional magnetic resonance imaging (fMRI)
Measured: MR assessment, 30 minutes
Spine kinematics
Sagittal and frontal plane lumbar and thoracic spinal curvature angles
Measured: Spinal kinematics assessment, 120 minutes
Spine biomechanics: muscle forces
segmental muscle forces (N/mm) during dynamic tasks
Measured: Spinal kinematics assessment, 120 minutes
Spine biomechanics: segmental loading
segmental loading (N) during dynamic tasks
Measured: Spinal kinematics assessment, 120 minutes
Proprioceptive repositioning errors
Sagittal plane repositioning errors assessed through lumbar and thoracic spinal curvature angles
Measured: Proprioceptive assessment, 10 minutes
Center of pressure displacements
Center of pressure displacements during vibrotactile stimulation while standing on a force plate
Measured: Postural stability assessment, 20 minutes
Secondary outcomes (8)
Segmental movement
Displacement (intervertebral angles) of the stimulated and adjacent spinal segments during mechanical pressure using dynamic T2 scans
Measured: MR assessment, 20 minutes
Fear of movement
score of the Tampa Scale of Kinesiphobia (TSK) questionnaire
Measured: Medical assessment, 5 minutes
Fear Avoidance Beliefs
scores of the Fear Aovidance Beliefs questionnaire (FABQ) in low back pain patients
Measured: Medical assessment, 5 minutes
Level of disability
scores of the Oswestry Disability Index (ODI) in low back pain patients
Measured: Medical assessment, 3 minutes
Pain characteristics
Pain quality assessment using the PainDETECT questionnaire in low back pain patients
Measured: Medical assessment, 1 minutes
Perception of the back
Assessment of self-perception of the back using the Fremantle Back Awareness Questionnaire
Measured: Medical assessment, 2 minutes
State and Trait anxiety
scores of state and trait anxiety (STAI) questionnaire
Measured: Medical assessment, 2 minutes
Perceived harmfulness of back stressing movements
Assessment of the perceived harmfulness of back stressing movements using the electronic version of the PHODA questionnaire
Measured: Medical assessment, 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start1 Apr 2019
- Primary completion17 Jan 2023
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich, Bern University of Applied Sciences
- Responsible party
- Principal investigator, Michael Meier, Balgrist University Hospital
- Investigators
- Michael Meier, PhD, Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255616
- Sponsor's protocol ID
- Project_X
- Status last verified
- Jan 2023
- First submitted
- 14 Aug 2017
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is planned to share the fMRI dataset in BIDS format on "openfmri.org"
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Back Pain: Unveiling the Contribution of Motor Control Adaption Using Biomechanical Modeling and Neuroimaging
- ClinicalTrials.gov ID
- NCT03255616
- Acronym / sponsor ID
- Project_X
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich, Bern University of Applied Sciences
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 21 Aug 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 reveal the potential sensorimotor reorganization of sensory input in low back pain patients and its association with different motor control strategies in LBP.
Detailed description
Background: Low back pain (LBP) is a major health issue. Treatment of chronic LBP is still a major challenge due to a lack of pathophysiological understanding. Thus, understanding LBP pathophysiology is a research priority. Adaptions of motor control likely play a significant role in chronic or recurrent LBP because motor control is crucial for spine posture, stability and movement. Different motor adaption strategies exist across individuals with LBP and two phenotypes representing the opposite ends of a spectrum have been suggested; i.e. "tight" control and "loose" control over trunk movement. The former would be associated with reduced trunk motor variability, the later with increased trunk motor variability. This conceptual framework is very useful to explain maintenance and aggravating of LBP because motor control adaptations are expected to have long-term consequences, such as increased spinal tissue loading, associated with degeneration of intervertebral discs and other tissues. Several knowledge gaps need to be addressed to test the validity of this framework: 1) Do loose/tight control phenotypes indeed exist and/or do other motor control adaption strategies exist? 2) Is reduced/altered paraspinal proprioceptive input associated with LBP related to neuroplastic cortical changes, thereby affecting the organizational structure in sensorimotor cortices and top-down trunk motor control? 3) Do psychological factors influence the organizational structure in sensorimotor cortices and motor control strategies? To address these knowledge gaps, the objectives of the current project are: I) To establish motor control phenotypes in LBP. Proprioceptive weighting and biomechanical assessment of dynamic movement tasks, including subject-specific spine kinematic variability and its relationship to pain duration, negative pain-related cognitions, segmental loadings and paraspinal muscle forces, will be performed. II) To test whether cortical proprioceptive maps differ between healthy subjects and patients with LBP. Brain activation in response to thoracolumbar vibrotactile stimulation will be interrogated using functional magnetic resonance imaging data and univariate and multivariate analysis based on machine learning. III) To test whether proprioceptive maps demonstrate a relationship to spine kinematic patterns, pain duration and negative pain-related cognitions in LBP patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Other: mechanical stimulation, Other: vibrotactile stimulationSpine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation |
| Low back pain patients | Experimental | Other: mechanical stimulation, Other: vibrotactile stimulationSpine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged between 18 and 60
- Written informed consent after being informed
- Aged between 18 and 60
- Low back pain for more than 1 week
Key exclusion criteria (15 listed)
- Consumption of alcohol, drugs, analgesics within the last 24 h
- Pregnancy
- acute and/or low recurrent back pain within the last 3 months
- Prior spine surgery
- Other chronic pain condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical stimulationmechanical non-painful low- and high pressure stimuli to thoracolumbar segments of healthy subjects and low back pain patients | Other | Healthy subjects, Low back pain patients |
| vibrotactile stimulationnon-painful vibrotactile stimulation within a frequency range between 20-150Hz to thoracolumbar segments of healthy subjects and low back pain patients | Other | Healthy subjects, Low back pain patients |
Primary outcome
Blood oxygenation level dependent (BOLD) responses
Time frame: MR assessment, 30 minutes
supraspinal BOLD responses induced by mechanical and vibrotactile stimulations of the back recorded by means of functional magnetic resonance imaging (fMRI)
Spine kinematics
Time frame: Spinal kinematics assessment, 120 minutes
Sagittal and frontal plane lumbar and thoracic spinal curvature angles
Spine biomechanics: muscle forces
Time frame: Spinal kinematics assessment, 120 minutes
segmental muscle forces (N/mm) during dynamic tasks
Spine biomechanics: segmental loading
Time frame: Spinal kinematics assessment, 120 minutes
segmental loading (N) during dynamic tasks
Proprioceptive repositioning errors
Time frame: Proprioceptive assessment, 10 minutes
Sagittal plane repositioning errors assessed through lumbar and thoracic spinal curvature angles
Center of pressure displacements
Time frame: Postural stability assessment, 20 minutes
Center of pressure displacements during vibrotactile stimulation while standing on a force plate
8 secondary outcomes
Segmental movement
Time frame: MR assessment, 20 minutes
Fear of movement
Time frame: Medical assessment, 5 minutes
Fear Avoidance Beliefs
Time frame: Medical assessment, 5 minutes
Level of disability
Time frame: Medical assessment, 3 minutes
Pain characteristics
Time frame: Medical assessment, 1 minutes
Perception of the back
Time frame: Medical assessment, 2 minutes
State and Trait anxiety
Time frame: Medical assessment, 2 minutes
Perceived harmfulness of back stressing movements
Time frame: Medical assessment, 15 minutes
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 18 Jan 2023.
- Individual participant dataSharing planned: Undecided. It is planned to share the fMRI dataset in BIDS format on "openfmri.org"
Related trials for Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Comparing Non-Medicine Strategies for Improving Low Back Pain
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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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.
Michael Meier, PhD principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical stimulation and vibrotactile stimulation in people with Low Back Pain, run by Balgrist University Hospital at 1 site in Switzerland.
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 4 inclusion and 15 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 18 Jan 2023. 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 Switzerland. 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?
Blood oxygenation level dependent (BOLD) responses (time frame: MR assessment, 30 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2023.