Low Back Pain: Unveiling the Contribution of Motor Control Adaption Using Biomechanical Modeling and Neuroimaging

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: mechanical stimulation; Other: vibrotactile stimulation

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8008
    • Balgrist University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy subjects; Spine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation	Other: mechanical stimulation; mechanical non-painful low- and high pressure stimuli to thoracolumbar segments of healthy subjects and low back pain patients; Other: vibrotactile stimulation; non-painful vibrotactile stimulation within a frequency range between 20-150Hz to thoracolumbar segments of healthy subjects and low back pain patients
Experimental: Low back pain patients; Spine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation	Other: mechanical stimulation; mechanical non-painful low- and high pressure stimuli to thoracolumbar segments of healthy subjects and low back pain patients; Other: vibrotactile stimulation; non-painful vibrotactile stimulation within a frequency range between 20-150Hz to thoracolumbar segments of healthy subjects and low back pain patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	MR assessment, 30 minutes
Spine kinematics	Sagittal and frontal plane lumbar and thoracic spinal curvature angles	Spinal kinematics assessment, 120 minutes
Spine biomechanics: muscle forces	segmental muscle forces (N/mm) during dynamic tasks	Spinal kinematics assessment, 120 minutes
Spine biomechanics: segmental loading	segmental loading (N) during dynamic tasks	Spinal kinematics assessment, 120 minutes
Proprioceptive repositioning errors	Sagittal plane repositioning errors assessed through lumbar and thoracic spinal curvature angles	Proprioceptive assessment, 10 minutes
Center of pressure displacements	Center of pressure displacements during vibrotactile stimulation while standing on a force plate	Postural stability assessment, 20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Segmental movement	Displacement (intervertebral angles) of the stimulated and adjacent spinal segments during mechanical pressure using dynamic T2 scans	MR assessment, 20 minutes
Fear of movement	score of the Tampa Scale of Kinesiphobia (TSK) questionnaire	Medical assessment, 5 minutes
Fear Avoidance Beliefs	scores of the Fear Aovidance Beliefs questionnaire (FABQ) in low back pain patients	Medical assessment, 5 minutes
Level of disability	scores of the Oswestry Disability Index (ODI) in low back pain patients	Medical assessment, 3 minutes
Pain characteristics	Pain quality assessment using the PainDETECT questionnaire in low back pain patients	Medical assessment, 1 minutes
Perception of the back	Assessment of self-perception of the back using the Fremantle Back Awareness Questionnaire	Medical assessment, 2 minutes
State and Trait anxiety	scores of state and trait anxiety (STAI) questionnaire	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	Medical assessment, 15 minutes

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Collaborators: Psychiatric University Hospital, Zurich; Bern University of Applied Sciences
• Investigators: Principal Investigator: Michael Meier, PhD, Balgrist University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): January 17, 2023
• Study Completion (Actual): January 17, 2023

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Project_X

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: It is planned to share the fMRI dataset in BIDS format on "openfmri.org"

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No