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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03255616
• Other study ID #: Project_X
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: January 17, 2023

Study information

• Verified date: January 2023
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 17, 2023
• Est. primary completion date: January 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• mechanical stimulation
mechanical non-painful low- and high pressure stimuli to thoracolumbar segments of healthy subjects and low back pain patients
• vibrotactile stimulation
non-painful vibrotactile stimulation within a frequency range between 20-150Hz to thoracolumbar segments of healthy subjects and low back pain patients

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zürich

Sponsors (3)

Lead Sponsor	Collaborator
Balgrist University Hospital	Bern University of Applied Sciences, Psychiatric University Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Spine kinematics	Sagittal and frontal plane lumbar and thoracic spinal curvature angles	Spinal kinematics assessment, 120 minutes
Primary	Spine biomechanics: muscle forces	segmental muscle forces (N/mm) during dynamic tasks	Spinal kinematics assessment, 120 minutes
Primary	Spine biomechanics: segmental loading	segmental loading (N) during dynamic tasks	Spinal kinematics assessment, 120 minutes
Primary	Proprioceptive repositioning errors	Sagittal plane repositioning errors assessed through lumbar and thoracic spinal curvature angles	Proprioceptive assessment, 10 minutes
Primary	Center of pressure displacements	Center of pressure displacements during vibrotactile stimulation while standing on a force plate	Postural stability assessment, 20 minutes
Secondary	Segmental movement	Displacement (intervertebral angles) of the stimulated and adjacent spinal segments during mechanical pressure using dynamic T2 scans	MR assessment, 20 minutes
Secondary	Fear of movement	score of the Tampa Scale of Kinesiphobia (TSK) questionnaire	Medical assessment, 5 minutes
Secondary	Fear Avoidance Beliefs	scores of the Fear Aovidance Beliefs questionnaire (FABQ) in low back pain patients	Medical assessment, 5 minutes
Secondary	Level of disability	scores of the Oswestry Disability Index (ODI) in low back pain patients	Medical assessment, 3 minutes
Secondary	Pain characteristics	Pain quality assessment using the PainDETECT questionnaire in low back pain patients	Medical assessment, 1 minutes
Secondary	Perception of the back	Assessment of self-perception of the back using the Fremantle Back Awareness Questionnaire	Medical assessment, 2 minutes
Secondary	State and Trait anxiety	scores of state and trait anxiety (STAI) questionnaire	Medical assessment, 2 minutes
Secondary	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