NCT03255616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
1.6 years until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

3.8 years

First QC Date

August 14, 2017

Last Update Submit

January 17, 2023

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (8)

  • Segmental movement

    MR assessment, 20 minutes

  • Fear of movement

    Medical assessment, 5 minutes

  • Fear Avoidance Beliefs

    Medical assessment, 5 minutes

  • Level of disability

    Medical assessment, 3 minutes

  • Pain characteristics

    Medical assessment, 1 minutes

  • +3 more secondary outcomes

Study Arms (2)

Healthy subjects

EXPERIMENTAL

Spine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation

Other: mechanical stimulationOther: vibrotactile stimulation

Low back pain patients

EXPERIMENTAL

Spine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation

Other: mechanical stimulationOther: vibrotactile stimulation

Interventions

mechanical stimulationOTHER

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

Healthy subjectsLow back pain patients
vibrotactile stimulationOTHER

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

Healthy subjectsLow back pain patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 60
  • Written informed consent after being informed
  • Aged between 18 and 60
  • Low back pain for more than 1 week

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Meier, PhD

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 21, 2017

Study Start

April 1, 2019

Primary Completion

January 17, 2023

Study Completion

January 17, 2023

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

CH(1)