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Completed

NCT Number: NCT03255616

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balgrist University Hospital

Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mechanical stimulation

Other

mechanical non-painful low- and high pressure stimuli to thoracolumbar segments of healthy subjects and low back pain patients

vibrotactile stimulation

Other

non-painful vibrotactile stimulation within a frequency range between 20-150Hz to thoracolumbar segments of healthy subjects and low back pain patients

Primary outcomes

  1. 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)

  2. Spine kinematics

    Time frame: Spinal kinematics assessment, 120 minutes

    Sagittal and frontal plane lumbar and thoracic spinal curvature angles

  3. Spine biomechanics: muscle forces

    Time frame: Spinal kinematics assessment, 120 minutes

    segmental muscle forces (N/mm) during dynamic tasks

  4. Spine biomechanics: segmental loading

    Time frame: Spinal kinematics assessment, 120 minutes

    segmental loading (N) during dynamic tasks

  5. Proprioceptive repositioning errors

    Time frame: Proprioceptive assessment, 10 minutes

    Sagittal plane repositioning errors assessed through lumbar and thoracic spinal curvature angles

  6. Center of pressure displacements

    Time frame: Postural stability assessment, 20 minutes

    Center of pressure displacements during vibrotactile stimulation while standing on a force plate

Secondary outcomes

  1. Segmental movement

    Time frame: MR assessment, 20 minutes

    Displacement (intervertebral angles) of the stimulated and adjacent spinal segments during mechanical pressure using dynamic T2 scans

  2. Fear of movement

    Time frame: Medical assessment, 5 minutes

    score of the Tampa Scale of Kinesiphobia (TSK) questionnaire

  3. Fear Avoidance Beliefs

    Time frame: Medical assessment, 5 minutes

    scores of the Fear Aovidance Beliefs questionnaire (FABQ) in low back pain patients

  4. Level of disability

    Time frame: Medical assessment, 3 minutes

    scores of the Oswestry Disability Index (ODI) in low back pain patients

  5. Pain characteristics

    Time frame: Medical assessment, 1 minutes

    Pain quality assessment using the PainDETECT questionnaire in low back pain patients

  6. Perception of the back

    Time frame: Medical assessment, 2 minutes

    Assessment of self-perception of the back using the Fremantle Back Awareness Questionnaire

  7. State and Trait anxiety

    Time frame: Medical assessment, 2 minutes

    scores of state and trait anxiety (STAI) questionnaire

  8. Perceived harmfulness of back stressing movements

    Time frame: Medical assessment, 15 minutes

    Assessment of the perceived harmfulness of back stressing movements using the electronic version of the PHODA questionnaire

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Collaborators

  • Bern University of Applied Sciences
  • Psychiatric University Hospital, Zurich

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2017
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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