Clinical trial NCT02773160: Motor Learning for the Lumbar Spine Using Sensor-based Postural Feedback: a Randomized Controlled Trial
Official title: Motor Learning for the Lumbar Spine Using Sensor-based Postural Feedback: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Non-specific Low Back Pain
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2016-05-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in lumbopelvic kinematics from baseline to immediately post-intervention
timeFrame: Day 1, immediately post-intervention
Secondary outcomes:
measure: usefulness of feedback (Numeric rating scale 0-10)
timeFrame: Day 1, immediately post-intervention
measure: Pain during the exercise trials (Numeric rating scale 0-10)
timeFrame: Day 1, immediately post-intervention
measure: Fear of low back pain during the exercise trials (Numeric rating scale 0-10)
timeFrame: Day 1, immediately post-intervention
measure: Fear of damaging the lumbar spine during the exercise trials (numeric rating scale 0-10)
timeFrame: Day 1, immediately post-intervention
measure: Borg-scale to measure fatigue during the exercise trials
timeFrame: Day 1, immediately post-intervention
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Universiteit Hasselt
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
affiliation: Hasselt University
name: Annick Timmermans, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jessa Ziekenhuis, Hasselt, Belgium
name: Enzo Olivieri, dr.
role: STUDY_CHAIR
References:
citation: 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.