Chronic Low Back PainNCT02239289
Use of Biofeedback Training to Correct Abnormal Neuromechanical Pattern in Chronic Low Back Pain Patients
A study testing Biofeedback in people with Chronic Low Back Pain and Mechanical Low Back Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.
Trial summary
The purpose of the present study is to evaluate the benefit of biofeedback training on the capacity of chronic low back pain patients to decrease their lumbar paraspinal muscles activity during trunk full flexion and its relationship with changes in clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low Back Pain, Mechanical Low Back Pain
- What is being tested?
- Biofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being between 18 and 60 years of age.
- Presence of non-specific chronic low back pain.
Who cannot join
- Prior surgery or major spine trauma.
- Lumbar scoliosis greater than 20°.
- Neuromuscular disease.
- Malignant tumor.
- Uncontrolled hypertension.
- Infection.
Show all 12Show fewer
- Neurological deficit.
- Symptomatic lumbar disc herniation.
- Pregnancy.
- Recent lumbar cortisone injection.
- Active lower body injury and/or disabling pain limiting the capacity to complete the experimentation.
- Being under medications known to impair physical effort and pain perception.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G9A 5H7
About this study
Official title: Correction of Abnormal Flexion-relaxation Phenomenon in Chronic Low Back Pain: the Benefit Associated With Biofeedback Training
The purpose of the present study is to evaluate the benefit of biofeedback training on the capacity of chronic low back pain patients to decrease their lumbar paraspinal muscles activity during trunk full flexion and its relationship with changes in clinical outcomes. To do so, twenty patients with nonspecific mechanical low back pain will be recruited and all participants will take part in four sessions of supervised biofeedback training, consisting of 5 blocks with at least 12 trunk flexion-extension tasks. It is hypothesized that participants will have improved neuromechanical parameters with the biofeedback training and that this improvement will be positively associated to changes in clinical outcomes. This study will also allow for generation of preliminary data, in order to plan for a larger randomized control trial.
- Conditions
- Chronic Low Back Pain, Mechanical Low Back Pain
- Being tested
- Biofeedback
- Keywords
- Low back pain, Rehabilitation, Biofeedback, Electromyography, Kinematic
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackOther
Idem as described in the arm section (above)
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback | Experimental | Subjects will be provided with four sessions of supervised biofeedback training Receives: Other: Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flexion-relaxation Ratio
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
Measured: Week 1
Flexion-relaxation Ratio
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
Measured: Week 2
Flexion-relaxation Ratio
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
Measured: Week 3
Flexion-relaxation Ratio
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
Measured: Week 4
Secondary outcomes (12)
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.
Measured: Week 1
Disability Level
Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.
Measured: Week 4
Pain Intensity in the Past Week
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Measured: Week 2
Current Pain Intensity
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Measured: Week 3
Fear of Movement Level
Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level.
Measured: Week 4
Current Pain Intensity
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Measured: Week 2
Current Pain Intensity
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Measured: Week 4
Pain Intensity in the Past Week
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Measured: Week 3
Pain Intensity in the Past Week
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
Measured: Week 4
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.
Measured: Week 2
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.
Measured: Week 3
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Descarreaux, Université du Québec à Trois-Rivières
- Investigators
- Martin Descarreaux, DC, PhD, Principal investigator, Université du Québec à Trois-Rivières
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239289
- Sponsor's protocol ID
- FIR UQTR 2013-2014
- Status last verified
- Jul 2015
- First submitted
- 4 Sep 2014
- Last updated
- 23 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.
PubMed 23777436Frank DL, Khorshid L, Kiffer JF, Moravec CS, McKee MG. Biofeedback in medicine: who, when, why and how? Ment Health Fam Med. 2010 Jun;7(2):85-91.
PubMed 22477926Hodges PW. Pain and motor control: From the laboratory to rehabilitation. J Electromyogr Kinesiol. 2011 Apr;21(2):220-8. doi: 10.1016/j.jelekin.2011.01.002.
PubMed 21306915Demoulin C, Crielaard JM, Vanderthommen M. Spinal muscle evaluation in healthy individuals and low-back-pain patients: a literature review. Joint Bone Spine. 2007 Jan;74(1):9-13. doi: 10.1016/j.jbspin.2006.02.013. Epub 2006 Nov 13.
PubMed 17174584
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Abnormal Flexion-relaxation Phenomenon in Chronic Low Back Pain: the Benefit Associated With Biofeedback Training
- ClinicalTrials.gov ID
- NCT02239289
- Acronym / sponsor ID
- FIR UQTR 2013-2014
- Conditions
- Chronic Low Back Pain, Mechanical Low Back Pain
- Keywords
- Low back pain, Rehabilitation, Biofeedback, Electromyography, Kinematic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Posted 23 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study is to evaluate the benefit of biofeedback training on the capacity of chronic low back pain patients to decrease their lumbar paraspinal muscles activity during trunk full flexion and its relationship with changes in clinical outcomes. To do so, twenty patients with nonspecific mechanical low back pain will be recruited and all participants will take part in four sessions of supervised biofeedback training, consisting of 5 blocks with at least 12 trunk flexion-extension tasks. It is hypothesized that participants will have improved neuromechanical parameters with the biofeedback training and that this improvement will be positively associated to changes in clinical outcomes. This study will also allow for generation of preliminary data, in order to plan for a larger randomized control trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | Experimental | Other: BiofeedbackSubjects will be provided with four sessions of supervised biofeedback training |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being between 18 and 60 years of age.
- Presence of non-specific chronic low back pain.
Key exclusion criteria (12 listed)
- Prior surgery or major spine trauma.
- Lumbar scoliosis greater than 20°.
- Neuromuscular disease.
- Malignant tumor.
- Uncontrolled hypertension.
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 |
|---|---|---|
| BiofeedbackIdem as described in the arm section (above) | Other | Biofeedback |
Primary outcome
Flexion-relaxation Ratio
Time frame: Week 1
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
Flexion-relaxation Ratio
Time frame: Week 2
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
Flexion-relaxation Ratio
Time frame: Week 3
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
Flexion-relaxation Ratio
Time frame: Week 4
Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.
12 secondary outcomes
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Time frame: Week 1
Disability Level
Time frame: Week 4
Pain Intensity in the Past Week
Time frame: Week 2
Current Pain Intensity
Time frame: Week 3
Fear of Movement Level
Time frame: Week 4
Current Pain Intensity
Time frame: Week 2
Current Pain Intensity
Time frame: Week 4
Pain Intensity in the Past Week
Time frame: Week 3
Pain Intensity in the Past Week
Time frame: Week 4
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Time frame: Week 2
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Time frame: Week 3
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23777436Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.
- Background: PubMed 22477926Frank DL, Khorshid L, Kiffer JF, Moravec CS, McKee MG. Biofeedback in medicine: who, when, why and how? Ment Health Fam Med. 2010 Jun;7(2):85-91.
- Background: PubMed 21306915Hodges PW. Pain and motor control: From the laboratory to rehabilitation. J Electromyogr Kinesiol. 2011 Apr;21(2):220-8. doi: 10.1016/j.jelekin.2011.01.002.
- Background: PubMed 17174584Demoulin C, Crielaard JM, Vanderthommen M. Spinal muscle evaluation in healthy individuals and low-back-pain patients: a literature review. Joint Bone Spine. 2007 Jan;74(1):9-13. doi: 10.1016/j.jbspin.2006.02.013. Epub 2006 Nov 13.
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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.
Martin Descarreaux, DC, PhD principal investigator
Université du Québec à Trois-Rivières
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback in people with Chronic Low Back Pain and Mechanical Low Back Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flexion-relaxation Ratio (time frame: Week 1). The study lists 4 primary outcomes in all. 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 NCT02239289, which also lists 4 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 23 Jul 2015.