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

Chronic Non-specific Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02773160
• Other study ID #: AcuteLearningEffects
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2016
• Last updated: May 13, 2016
• Start date: April 2015
• Est. completion date: March 2017

Study information

• Verified date: May 2016
• Source: Hasselt University
• Contact: Thomas Matheve, drs.
• Email: Thomas.Matheve[@]UHasselt.be
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Non-specific Low Back Pain
• Low Back Pain

Intervention

Other:
• Sensor-based postural feedback
Motion tracking sensors will provide feedback to subjects during the learning phase of a motor control task
• Mirror feedback
Subjects will receive feedback from a mirror during the learning phase of a motor control task
• Control group
Subjects will receive no feedback during the learning phase of a motor control task

Locations

Country	Name	City	State
Belgium	Universiteit Hasselt	Diepenbeek
Belgium	Jessa Ziekenhuis	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Pain during the exercise trials (Numeric rating scale 0-10)	Outcome measure primarily used as possible covariate	Day 1, immediately post-intervention	No
Secondary	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	No
Secondary	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	No
Secondary	Borg-scale to measure fatigue during the exercise trials	Outcome measure primarily used as possible covariate	Day 1, immediately post-intervention	No