- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02239289
Use of Biofeedback Training to Correct Abnormal Neuromechanical Pattern in Chronic Low Back Pain Patients
July 10, 2015 updated by: Martin Descarreaux, Université du Québec à Trois-Rivières
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Trois-Rivières, Quebec, Canada, G9A 5H7
- Université du Québec à Trois-Rivières
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being between 18 and 60 years of age.
- Presence of non-specific chronic low back pain.
Exclusion Criteria:
- Prior surgery or major spine trauma.
- Lumbar scoliosis greater than 20°.
- Neuromuscular disease.
- Malignant tumor.
- Uncontrolled hypertension.
- Infection.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Biofeedback
Subjects will be provided with four sessions of supervised biofeedback training
|
Idem as described in the arm section (above)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 1
|
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.
|
Week 2
|
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.
|
Week 3
|
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.
|
Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Time Frame: Week 1
|
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.
|
Week 1
|
Disability Level
Time Frame: Week 4
|
Oswestry disability index ranges from 0 to 100.
A higher score indicates higher disability.
|
Week 4
|
Pain Intensity in the Past Week
Time Frame: Week 2
|
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
|
Week 2
|
Current Pain Intensity
Time Frame: Week 3
|
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
|
Week 3
|
Fear of Movement Level
Time Frame: Week 4
|
Tampa scale for kinesiophobia ranges from 0 to 68.
Higher score indicates higher fear of movement level.
|
Week 4
|
Current Pain Intensity
Time Frame: Week 2
|
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
|
Week 2
|
Current Pain Intensity
Time Frame: Week 4
|
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
|
Week 4
|
Pain Intensity in the Past Week
Time Frame: Week 3
|
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
|
Week 3
|
Pain Intensity in the Past Week
Time Frame: Week 4
|
101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).
|
Week 4
|
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Time Frame: Week 2
|
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.
|
Week 2
|
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Time Frame: Week 3
|
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.
|
Week 3
|
Lumbo-pelvic Range of Motion During Trunk Flexion-extension
Time Frame: Week 4
|
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.
|
Week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Martin Descarreaux, DC, PhD, Université du Québec à Trois-Rivières
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Hodges 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.
- Frank 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.
- Demoulin 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
September 4, 2014
First Submitted That Met QC Criteria
September 10, 2014
First Posted (Estimate)
September 12, 2014
Study Record Updates
Last Update Posted (Estimate)
July 23, 2015
Last Update Submitted That Met QC Criteria
July 10, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIR UQTR 2013-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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