Complexity & Distraction in LBP

Study Overview
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Brief Summary
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Motor control, notably expressed through the complexity of the variability of the locomotor pattern, is disturbed at the central level by an apprehension of pain and movement, more than pain itself (or by biomechanical / structural damage of the spine) in chronic low back pain (cLBP) patients. The aim of this study is to control that variability is reduced during gait at comfortable level and to test that distraction can reduce pain avoidance and therefore increase variability in cLBP patients.

Official Title
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Relationship Between Complexity and Pain in a Walking Task With Distraction in the Chronic Low Back Pain Patient by Fractal Analysis: Pilot Study

Conditions
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Chronic Low Back Pain, Gait, Motor Activity

Intervention / Treatment
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* Behavioral: walk test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have his informed consent and signed the consent form. The patient must be affiliated or beneficiary of a health insurance plan The patient is at least 18 years old and under 75 years old Patients with common chronic low back pain for more than 6 months Exclusion Criteria: The subject participates in another interventional study The subject is in an exclusion period determined by a previous study The subject is under the protection of justice, guardianship or curatorship The subject refuses to sign the consent It is impossible to inform the subject Chronic symptomatic low back pain (tumoral pathology, infectious, or progressive inflammatory) Unable to walk for more than 10 minutes (during interrogation) Lower limb pain (EVA lower limb (s) ≥ Lumbar EVA)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>Patients are asked to walk ont a treadmill in four conditions: with and without distraction (virtual environment) and at different speed (comfortable vs high). | Behavioral: walk test<br>* The patient will have to walk on a treadmill in four different conditions: without distraction at preferential speed with distraction at preferential speed without distraction at the speed of 130% of the preferential speed with distraction at the speed of 130% of the preferential speed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of the fractal exponent when walking without distraction at preferential speed | [0,5; 1,5] | Day 0 | 
| Estimation of the fractal exponent when walking with distraction at preferential speed | [0,5; 1,5] | Day 0 | 
| Estimation of the fractal exponent when walking without distraction at the speed of 130% of the preferential speed | [0,5; 1,5] | Day 0 | 
| Estimation of the fractal exponent when walking with distraction at the speed of 130% of the preferential speed | [0,5; 1,5] | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EVA after walking without distraction at preferential speed | [0; 100] | Day 0 | 
| EVA after walking with distraction at preferential speed | [0; 100] | Day 0 | 
| EVA after walking without distraction at the speed of 130% of the preferential speed | [0; 100] | Day 0 | 
| EVA after walking with distraction at the speed of 130% of the preferential speed | [0; 100] | Day 0 | 
| Reaction time to auditory stimuli without distraction at preferential speed | second | Day 0 | 
| Reaction time to auditory stimuli with distraction at preferential speed | second | Day 0 | 
| Reaction time to auditory stimuli without distraction at the speed of 130% of the preferential speed | second | Day 0 | 
| Reaction time to auditory stimuli with distraction at the speed of 130% of the preferential speed | second | Day 0 | 
| Tampa Scale for kinesophobia | The total score ranges between 17 and 68. A high value on the Tampa Scale for the Tampa Scale for kinesophobia indicates a high degree of kinesiophobia | Day 0 | 
| Dallas Pain Questionnaire for Back Pain | This questionnaire has been designed to give health care provider information as to how pain affects daily activities. It assesses the impact of low back pain (LBP) on four components (daily activities, work and leisure activities, anxiety/depression, and social interest) (expressed as a value between 0 and 100) of daily life.The higher the score, the more the low back pain has an impact on the quality of life. | Day 0 | 
| Quebec Back Pain Disability Index | The item scores were summed for a total score between 0 and 100, with higher numbers representing greater levels of disability. | Day 0 | 
| Fear Avoidance Belief Questionnaire (FABQ) | The Fear Avoidance Belief Questionnaire is a two-part questionnaire assessing fear, avoidance, and beliefs about professional activity and physical activity. The FABQ physical activity score of 14 responds better to a cognitive/behavioral approach and de-emphasize the traditional pain specific treatment goals. The Fear Avoidance Belief Questionnaire Work score that is >18 has a decrease likelihood of success from a joint manipulation/mobilization treatment approach. The Fear Avoidance Belief Questionnaire Work score of 34 or greater increases the risk for prolonged disability and will most likely require a multi-disciplinary approach to treatment. | Day 0 | 
| Hospital and Anxiety Depression Scale | Score: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) | Day 0 |