Chronic Non-specific Low Back PainNCT02773160
Motor Learning for the Lumbar Spine Using Sensor-based Postural Feedback: a Randomized Controlled Trial
A study testing Sensor-based postural feedback and Mirror feedback in people with Chronic Non-specific Low Back Pain, run by Hasselt University at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Non-specific Low Back Pain
- What is being tested?
- Sensor-based postural feedback and Mirror feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesBelgium
- Study dates
- Apr 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic non-specific low back pain
- Age 18-65
- Able to understand Dutch
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Thomas Matheve, drs. contact
Annick Timmermans, prof. dr. contact
Belgium2 sites, 2 recruiting
- Recruiting
Universiteit Hasselt
Diepenbeek, 3590
thomas Matheve, drs.
Martine Timmermans, prof. dr.
- Recruiting
Jessa Ziekenhuis
Hasselt, 3500
Thomas Matheve, drs.
Enzo Olivieri, dr.
About this study
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.
- Conditions
- Chronic Non-specific Low Back Pain
- Being tested
- Sensor-based postural feedback, Mirror feedback, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor-based postural feedbackOther
Motion tracking sensors will provide feedback to subjects during the learning phase of a motor control task
Mirror feedbackOther
Subjects will receive feedback from a mirror during the learning phase of a motor control task
Control groupOther
Subjects will receive no feedback during the learning phase of a motor control task
| Study group | Role | What they receive |
|---|---|---|
| Sensor-based postural feedback | Experimental | 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 Receives: Other: Sensor-based postural feedback |
| Mirror Feedback | Experimental | Subjects will receive feedback from a mirror while practicing the motor control task Receives: Other: Mirror feedback |
| control group | Active comparator | Subjects will receive no feedback while practicing the motor control task Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, immediately post-intervention
Secondary outcomes (5)
usefulness of feedback (Numeric rating scale 0-10)
How useful was the feedback that was provided to the subjects during the exercise trials?
Measured: Day 1, immediately post-intervention
Pain during the exercise trials (Numeric rating scale 0-10)
Outcome measure primarily used as possible covariate
Measured: 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
Measured: 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
Measured: Day 1, immediately post-intervention
Borg-scale to measure fatigue during the exercise trials
Outcome measure primarily used as possible covariate
Measured: Day 1, immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startApr 2015
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Non-specific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Annick Timmermans, Hasselt University
- Investigators
- Annick Timmermans, prof. dr., Principal investigator, Hasselt UniversityEnzo Olivieri, dr., Study chair, Jessa Ziekenhuis, Hasselt, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773160
- Sponsor's protocol ID
- AcuteLearningEffects
- Status last verified
- May 2016
- First submitted
- 11 Jan 2016
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Matheve T, Timmermans A, Danneels L, De Baets L. Task-Specific Perceived Harmfulness Predicts Protective Movement Behaviour in Chronic Low Back Pain. J Clin Med. 2024 Aug 25;13(17):5025. doi: 10.3390/jcm13175025.
PubMed 39274238Matheve 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.
PubMed 30253807
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Learning for the Lumbar Spine Using Sensor-based Postural Feedback: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02773160
- Acronym / sponsor ID
- AcuteLearningEffects
- Conditions
- Chronic Non-specific Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- Apr 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sensor-based postural feedback | Experimental | Other: Sensor-based postural feedbackSubjects 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 | Experimental | Other: Mirror feedbackSubjects will receive feedback from a mirror while practicing the motor control task |
| control group | Active comparator | Other: Control groupSubjects will receive no feedback while practicing the motor control task |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic non-specific low back pain
- Age 18-65
- Able to understand Dutch
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensor-based postural feedbackMotion tracking sensors will provide feedback to subjects during the learning phase of a motor control task | Other | Sensor-based postural feedback |
| Mirror feedbackSubjects will receive feedback from a mirror during the learning phase of a motor control task | Other | Mirror Feedback |
| Control groupSubjects will receive no feedback during the learning phase of a motor control task | Other | control group |
Primary outcome
Change in lumbopelvic kinematics from baseline to immediately post-intervention
Time frame: 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.
5 secondary outcomes
usefulness of feedback (Numeric rating scale 0-10)
Time frame: Day 1, immediately post-intervention
Pain during the exercise trials (Numeric rating scale 0-10)
Time frame: Day 1, immediately post-intervention
Fear of low back pain during the exercise trials (Numeric rating scale 0-10)
Time frame: Day 1, immediately post-intervention
Fear of damaging the lumbar spine during the exercise trials (numeric rating scale 0-10)
Time frame: Day 1, immediately post-intervention
Borg-scale to measure fatigue during the exercise trials
Time frame: Day 1, immediately post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Derived from this study: PubMed 39274238Matheve T, Timmermans A, Danneels L, De Baets L. Task-Specific Perceived Harmfulness Predicts Protective Movement Behaviour in Chronic Low Back Pain. J Clin Med. 2024 Aug 25;13(17):5025. doi: 10.3390/jcm13175025.
- Derived from this study: PubMed 30253807Matheve 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Matheve, drs. contact
Annick Timmermans, prof. dr. contact
Annick Timmermans, prof. dr. principal investigator
Hasselt University
Enzo Olivieri, dr. study chair
Jessa Ziekenhuis, Hasselt, Belgium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor-based postural feedback and Mirror feedback in people with Chronic Non-specific Low Back Pain, run by Hasselt University at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Matheve, drs. (Thomas.Matheve@UHasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lumbopelvic kinematics from baseline to immediately post-intervention (time frame: Day 1, immediately post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02773160, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.