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

Not Applicable

• Conditions: Chronic Non-specific Low Back Pain
• Interventions: Other: Sensor-based postural feedback; Other: Mirror feedback; Other: Control group

• Registration Number: NCT02773160
• Lead Sponsor: Hasselt University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-01-11
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-13
• Last Update Submitted: 2016-05-13
• Study First Posted: 2016-05-16
• Last Update Posted: 2016-05-16
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sensor-based postural feedback	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
Mirror Feedback	Mirror feedback	Subjects will receive feedback from a mirror while practicing the motor control task
control group	Control group	Subjects will receive no feedback while practicing the motor control task

Primary Outcome Measures

Name	Time	Method
Change in lumbopelvic kinematics from baseline to immediately post-intervention	Day 1, 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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Universiteit Hasselt; 🇧🇪 Diepenbeek, Belgium

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium