Complexity & Distraction in LBP (CoDiLoBP)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain; Gait; Motor Activity
• Intervention / Treatment: Behavioral: walk test

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • Nîmes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Arnaud Dupeyron, Pr, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): May 17, 2018
• Study Completion (Actual): May 17, 2018

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: LOCAL/2017/AH-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No