Low Back Pain: Unveiling the Contribution of Motor Control Adaption Using Biomechanical Modeling and Neuroimaging
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
mechanical stimulation
vibrotactile stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Low Back Pain
Eligibility Criteria
Inclusion criteria healthy subjects:
- Aged between 18 and 60
- Written informed consent after being informed
Inclusion criteria low back pain patients:
- Aged between 18 and 60
- Low back pain for more than 1 week
Exclusion criteria healthy subjects:
- 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
- MR-contraindications
- Body mass index (BMI) > 30 kg/m2
Exclusion criteria low back pain patients:
- 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
Sites / Locations
- Balgrist University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy subjects
Low back pain patients
Arm Description
Spine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation
Spine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation
Outcomes
Primary Outcome Measures
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)
Spine kinematics
Sagittal and frontal plane lumbar and thoracic spinal curvature angles
Spine biomechanics: muscle forces
segmental muscle forces (N/mm) during dynamic tasks
Spine biomechanics: segmental loading
segmental loading (N) during dynamic tasks
Proprioceptive repositioning errors
Sagittal plane repositioning errors assessed through lumbar and thoracic spinal curvature angles
Center of pressure displacements
Center of pressure displacements during vibrotactile stimulation while standing on a force plate
Secondary Outcome Measures
Segmental movement
Displacement (intervertebral angles) of the stimulated and adjacent spinal segments during mechanical pressure using dynamic T2 scans
Fear of movement
score of the Tampa Scale of Kinesiphobia (TSK) questionnaire
Fear Avoidance Beliefs
scores of the Fear Aovidance Beliefs questionnaire (FABQ) in low back pain patients
Level of disability
scores of the Oswestry Disability Index (ODI) in low back pain patients
Pain characteristics
Pain quality assessment using the PainDETECT questionnaire in low back pain patients
Perception of the back
Assessment of self-perception of the back using the Fremantle Back Awareness Questionnaire
State and Trait anxiety
scores of state and trait anxiety (STAI) questionnaire
Perceived harmfulness of back stressing movements
Assessment of the perceived harmfulness of back stressing movements using the electronic version of the PHODA questionnaire
Full Information
NCT ID
NCT03255616
First Posted
August 14, 2017
Last Updated
January 17, 2023
Sponsor
Balgrist University Hospital
Collaborators
Psychiatric University Hospital, Zurich, Bern University of Applied Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03255616
Brief Title
Low Back Pain: Unveiling the Contribution of Motor Control Adaption Using Biomechanical Modeling and Neuroimaging
Official Title
Low Back Pain: Unveiling the Contribution of Motor Control Adaption Using Biomechanical Modeling and Neuroimaging
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
January 17, 2023 (Actual)
Study Completion Date
January 17, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Balgrist University Hospital
Collaborators
Psychiatric University Hospital, Zurich, Bern University of Applied Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
Spine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation
Arm Title
Low back pain patients
Arm Type
Experimental
Arm Description
Spine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation
Intervention Type
Other
Intervention Name(s)
mechanical stimulation
Intervention Description
mechanical non-painful low- and high pressure stimuli to thoracolumbar segments of healthy subjects and low back pain patients
Intervention Type
Other
Intervention Name(s)
vibrotactile stimulation
Intervention Description
non-painful vibrotactile stimulation within a frequency range between 20-150Hz to thoracolumbar segments of healthy subjects and low back pain patients
Primary Outcome Measure Information:
Title
Blood oxygenation level dependent (BOLD) responses
Description
supraspinal BOLD responses induced by mechanical and vibrotactile stimulations of the back recorded by means of functional magnetic resonance imaging (fMRI)
Time Frame
MR assessment, 30 minutes
Title
Spine kinematics
Description
Sagittal and frontal plane lumbar and thoracic spinal curvature angles
Time Frame
Spinal kinematics assessment, 120 minutes
Title
Spine biomechanics: muscle forces
Description
segmental muscle forces (N/mm) during dynamic tasks
Time Frame
Spinal kinematics assessment, 120 minutes
Title
Spine biomechanics: segmental loading
Description
segmental loading (N) during dynamic tasks
Time Frame
Spinal kinematics assessment, 120 minutes
Title
Proprioceptive repositioning errors
Description
Sagittal plane repositioning errors assessed through lumbar and thoracic spinal curvature angles
Time Frame
Proprioceptive assessment, 10 minutes
Title
Center of pressure displacements
Description
Center of pressure displacements during vibrotactile stimulation while standing on a force plate
Time Frame
Postural stability assessment, 20 minutes
Secondary Outcome Measure Information:
Title
Segmental movement
Description
Displacement (intervertebral angles) of the stimulated and adjacent spinal segments during mechanical pressure using dynamic T2 scans
Time Frame
MR assessment, 20 minutes
Title
Fear of movement
Description
score of the Tampa Scale of Kinesiphobia (TSK) questionnaire
Time Frame
Medical assessment, 5 minutes
Title
Fear Avoidance Beliefs
Description
scores of the Fear Aovidance Beliefs questionnaire (FABQ) in low back pain patients
Time Frame
Medical assessment, 5 minutes
Title
Level of disability
Description
scores of the Oswestry Disability Index (ODI) in low back pain patients
Time Frame
Medical assessment, 3 minutes
Title
Pain characteristics
Description
Pain quality assessment using the PainDETECT questionnaire in low back pain patients
Time Frame
Medical assessment, 1 minutes
Title
Perception of the back
Description
Assessment of self-perception of the back using the Fremantle Back Awareness Questionnaire
Time Frame
Medical assessment, 2 minutes
Title
State and Trait anxiety
Description
scores of state and trait anxiety (STAI) questionnaire
Time Frame
Medical assessment, 2 minutes
Title
Perceived harmfulness of back stressing movements
Description
Assessment of the perceived harmfulness of back stressing movements using the electronic version of the PHODA questionnaire
Time Frame
Medical assessment, 15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria healthy subjects:
Aged between 18 and 60
Written informed consent after being informed
Inclusion criteria low back pain patients:
Aged between 18 and 60
Low back pain for more than 1 week
Exclusion criteria healthy subjects:
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
MR-contraindications
Body mass index (BMI) > 30 kg/m2
Exclusion criteria low back pain patients:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Meier, PhD
Organizational Affiliation
Balgrist University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Balgrist University Hospital
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is planned to share the fMRI dataset in BIDS format on "openfmri.org"
Learn more about this trial
Low Back Pain: Unveiling the Contribution of Motor Control Adaption Using Biomechanical Modeling and Neuroimaging
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