Clinical trial NCT03255616: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: Psychiatric University Hospital, Zurich
name: Bern University of Applied Sciences
First posted: 2017-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Blood oxygenation level dependent (BOLD) responses
timeFrame: MR assessment, 30 minutes
measure: Spine kinematics
timeFrame: Spinal kinematics assessment, 120 minutes
measure: Spine biomechanics: muscle forces
timeFrame: Spinal kinematics assessment, 120 minutes
measure: Spine biomechanics: segmental loading
timeFrame: Spinal kinematics assessment, 120 minutes
measure: Proprioceptive repositioning errors
timeFrame: Proprioceptive assessment, 10 minutes
measure: Center of pressure displacements
timeFrame: Postural stability assessment, 20 minutes
Secondary outcomes:
measure: Segmental movement
timeFrame: MR assessment, 20 minutes
measure: Fear of movement
timeFrame: Medical assessment, 5 minutes
measure: Fear Avoidance Beliefs
timeFrame: Medical assessment, 5 minutes
measure: Level of disability
timeFrame: Medical assessment, 3 minutes
measure: Pain characteristics
timeFrame: Medical assessment, 1 minutes
measure: Perception of the back
timeFrame: Medical assessment, 2 minutes
measure: State and Trait anxiety
timeFrame: Medical assessment, 2 minutes
measure: Perceived harmfulness of back stressing movements
timeFrame: Medical assessment, 15 minutes
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Balgrist University Hospital
name: Michael Meier, PhD
role: PRINCIPAL_INVESTIGATOR
References: