Complexity & Distraction in LBP

Chronic Low Back Pain Clinical Trial

— CoDiLoBP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03633578
• Other study ID #: LOCAL/2017/AH-01
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: May 17, 2018

Study information

• Verified date: December 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 17, 2018
• Est. primary completion date: May 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Gait
• Low Back Pain
• Motor Activity

Intervention

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

Locations

Country	Name	City	State
France	Nimes University Hospital	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of the fractal exponent when walking without distraction at preferential speed	[0,5; 1,5]	Day 0
Primary	Estimation of the fractal exponent when walking with distraction at preferential speed	[0,5; 1,5]	Day 0
Primary	Estimation of the fractal exponent when walking without distraction at the speed of 130% of the preferential speed	[0,5; 1,5]	Day 0
Primary	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	EVA after walking without distraction at preferential speed	[0; 100]	Day 0
Secondary	EVA after walking with distraction at preferential speed	[0; 100]	Day 0
Secondary	EVA after walking without distraction at the speed of 130% of the preferential speed	[0; 100]	Day 0
Secondary	EVA after walking with distraction at the speed of 130% of the preferential speed	[0; 100]	Day 0
Secondary	Reaction time to auditory stimuli without distraction at preferential speed	second	Day 0
Secondary	Reaction time to auditory stimuli with distraction at preferential speed	second	Day 0
Secondary	Reaction time to auditory stimuli without distraction at the speed of 130% of the preferential speed	second	Day 0
Secondary	Reaction time to auditory stimuli with distraction at the speed of 130% of the preferential speed	second	Day 0
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospital and Anxiety Depression Scale	Score: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)	Day 0