Clinical trial NCT03633578: Complexity & Distraction in LBP
Official title: Relationship Between Complexity and Pain in a Walking Task With Distraction in the Chronic Low Back Pain Patient by Fractal Analysis: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Gait
Motor Activity
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Estimation of the fractal exponent when walking without distraction at preferential speed
timeFrame: Day 0
measure: Estimation of the fractal exponent when walking with distraction at preferential speed
timeFrame: Day 0
measure: Estimation of the fractal exponent when walking without distraction at the speed of 130% of the preferential speed
timeFrame: Day 0
measure: Estimation of the fractal exponent when walking with distraction at the speed of 130% of the preferential speed
timeFrame: Day 0
Secondary outcomes:
measure: EVA after walking without distraction at preferential speed
timeFrame: Day 0
measure: EVA after walking with distraction at preferential speed
timeFrame: Day 0
measure: EVA after walking without distraction at the speed of 130% of the preferential speed
timeFrame: Day 0
measure: EVA after walking with distraction at the speed of 130% of the preferential speed
timeFrame: Day 0
measure: Reaction time to auditory stimuli without distraction at preferential speed
timeFrame: Day 0
measure: Reaction time to auditory stimuli with distraction at preferential speed
timeFrame: Day 0
measure: Reaction time to auditory stimuli without distraction at the speed of 130% of the preferential speed
timeFrame: Day 0
measure: Reaction time to auditory stimuli with distraction at the speed of 130% of the preferential speed
timeFrame: Day 0
measure: Tampa Scale for kinesophobia
timeFrame: Day 0
measure: Dallas Pain Questionnaire for Back Pain
timeFrame: Day 0
measure: Quebec Back Pain Disability Index
timeFrame: Day 0
measure: Fear Avoidance Belief Questionnaire (FABQ)
timeFrame: Day 0
measure: Hospital and Anxiety Depression Scale
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Nimes University Hospital
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Arnaud Dupeyron, Pr
role: PRINCIPAL_INVESTIGATOR
References: