Motor Learning for the Lumbar Spine Using Sensor-based Postural Feedback: a Randomized Controlled Trial

A large subgroup of patients with chronic non-specific low back pain have motor control impairments. During motor control exercises, different forms of external feedback can be used to support training. This randomized controlled trial will investigate the effectiveness of different forms of external feedback during the learning phase of a motor control task for the lumbar spine in healthy subjects and patients with chronic non-specific low back pain (CNSLBP). Both healthy subjects and patients with CNSLBP will be randomized into three groups: one group will receive feedback from motion sensors, one group from a mirror and one group will receive no feedback (control group). A single session intervention with measurements at baseline and immediately post-intervention will be used.

Study Overview

• Status: Unknown
• Conditions: Chronic Non-specific Low Back Pain
• Intervention / Treatment: Other: Sensor-based postural feedback; Other: Mirror feedback; Other: Control group

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Diepenbeek, Belgium, 3590
    • Recruiting
    • Universiteit Hasselt
    • Contact: Thomas Matheve, drs.
    • Principal Investigator: Martine Timmermans, prof. dr.
  • Hasselt, Belgium, 3500
    • Recruiting
    • Jessa Ziekenhuis
    • Contact: Thomas Matheve, drs.
    • Sub-Investigator: Enzo Olivieri, dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic non-specific low back pain
• Age 18-65
• Able to understand Dutch

Exclusion Criteria:

• Subjects that received lumbar stabilization exercises in the past year
• Spinal surgery in the past
• Pregnancy
• Serious underlying pathologies (e.g. multiple sclerosis, tumors,…)
• Signs or symptoms of nerve root involvement
• Any physical condition at the moment of testing that can interfere with activities of daily living (e.g. serious knee pain)
• Known skin-allergy for tape
• BMI > 30kg/m²

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sensor-based postural feedback; Subjects will receive visual feedback on a computer screen while practicing the motor control task. The feedback is based on information from from motion sensors that mointor the movements of the lumbar spine	Other: Sensor-based postural feedback; Motion tracking sensors will provide feedback to subjects during the learning phase of a motor control task
Experimental: Mirror Feedback; Subjects will receive feedback from a mirror while practicing the motor control task	Other: Mirror feedback; Subjects will receive feedback from a mirror during the learning phase of a motor control task
Active Comparator: control group; Subjects will receive no feedback while practicing the motor control task	Other: Control group; Subjects will receive no feedback during the learning phase of a motor control task

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lumbopelvic kinematics from baseline to immediately post-intervention	Kinematics will be assessed using motion sensors that are mounted on the skin at the spinous processes of L1 and S1, and at the femur.	Day 1, immediately post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
usefulness of feedback (Numeric rating scale 0-10)	How useful was the feedback that was provided to the subjects during the exercise trials?	Day 1, immediately post-intervention
Pain during the exercise trials (Numeric rating scale 0-10)	Outcome measure primarily used as possible covariate	Day 1, immediately post-intervention
Fear of low back pain during the exercise trials (Numeric rating scale 0-10)	Outcome measure primarily used as possible covariate	Day 1, immediately post-intervention
Fear of damaging the lumbar spine during the exercise trials (numeric rating scale 0-10)	Outcome measure primarily used as possible covariate	Day 1, immediately post-intervention
Borg-scale to measure fatigue during the exercise trials	Outcome measure primarily used as possible covariate	Day 1, immediately post-intervention

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital
• Investigators: Principal Investigator: Annick Timmermans, prof. dr., Hasselt University; Study Chair: Enzo Olivieri, dr., Jessa Ziekenhuis, Hasselt, Belgium

Publications and helpful links

General Publications

• Matheve T, Brumagne S, Demoulin C, Timmermans A. Sensor-based postural feedback is more effective than conventional feedback to improve lumbopelvic movement control in patients with chronic low back pain: a randomised controlled trial. J Neuroeng Rehabil. 2018 Sep 26;15(1):85. doi: 10.1186/s12984-018-0423-6.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: May 13, 2016
• First Posted (Estimate): May 16, 2016

Study Record Updates

• Last Update Posted (Estimate): May 16, 2016
• Last Update Submitted That Met QC Criteria: May 13, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED