Use of Biofeedback Training to Correct Abnormal Neuromechanical Pattern in Chronic Low Back Pain Patients

Study Overview
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Brief Summary
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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.

Official Title
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Correction of Abnormal Flexion-relaxation Phenomenon in Chronic Low Back Pain: the Benefit Associated With Biofeedback Training

Conditions
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Chronic Low Back Pain, Mechanical Low Back Pain

Intervention / Treatment
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* Other: Biofeedback


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biofeedback<br>Subjects will be provided with four sessions of supervised biofeedback training | Other: Biofeedback<br>* Idem as described in the arm section (above)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 1 | 
| Disability Level | Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability. | Week 4 | 
| Pain Intensity in the Past Week | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Week 2 | 
| Current Pain Intensity | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Week 3 | 
| Fear of Movement Level | Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level. | Week 4 | 
| Current Pain Intensity | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Week 2 | 
| Current Pain Intensity | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Week 4 | 
| Pain Intensity in the Past Week | 101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain). | Week 3 | 
| Pain Intensity in the Past Week | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biofeedback, Low back pain, Rehabilitation, Electromyography, Kinematic