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Complexity & Distraction in LBP (CoDiLoBP)

Primary Purpose

Chronic Low Back Pain, Gait, Motor Activity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
walk test
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Nimes University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional group

Arm Description

Patients are asked to walk ont a treadmill in four conditions: with and without distraction (virtual environment) and at different speed (comfortable vs high).

Outcomes

Primary Outcome Measures

Estimation of the fractal exponent when walking without distraction at preferential speed
[0,5; 1,5]
Estimation of the fractal exponent when walking with distraction at preferential speed
[0,5; 1,5]
Estimation of the fractal exponent when walking without distraction at the speed of 130% of the preferential speed
[0,5; 1,5]
Estimation of the fractal exponent when walking with distraction at the speed of 130% of the preferential speed
[0,5; 1,5]

Secondary Outcome Measures

EVA after walking without distraction at preferential speed
[0; 100]
EVA after walking with distraction at preferential speed
[0; 100]
EVA after walking without distraction at the speed of 130% of the preferential speed
[0; 100]
EVA after walking with distraction at the speed of 130% of the preferential speed
[0; 100]
Reaction time to auditory stimuli without distraction at preferential speed
second
Reaction time to auditory stimuli with distraction at preferential speed
second
Reaction time to auditory stimuli without distraction at the speed of 130% of the preferential speed
second
Reaction time to auditory stimuli with distraction at the speed of 130% of the preferential speed
second
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
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.
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.
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.
Hospital and Anxiety Depression Scale
Score: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

Full Information

First Posted
August 14, 2018
Last Updated
December 9, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT03633578
Brief Title
Complexity & Distraction in LBP
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
May 17, 2018 (Actual)
Study Completion Date
May 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Gait, Motor Activity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Patients are asked to walk ont a treadmill in four conditions: with and without distraction (virtual environment) and at different speed (comfortable vs high).
Intervention Type
Behavioral
Intervention Name(s)
walk test
Intervention Description
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
Primary Outcome Measure Information:
Title
Estimation of the fractal exponent when walking without distraction at preferential speed
Description
[0,5; 1,5]
Time Frame
Day 0
Title
Estimation of the fractal exponent when walking with distraction at preferential speed
Description
[0,5; 1,5]
Time Frame
Day 0
Title
Estimation of the fractal exponent when walking without distraction at the speed of 130% of the preferential speed
Description
[0,5; 1,5]
Time Frame
Day 0
Title
Estimation of the fractal exponent when walking with distraction at the speed of 130% of the preferential speed
Description
[0,5; 1,5]
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
EVA after walking without distraction at preferential speed
Description
[0; 100]
Time Frame
Day 0
Title
EVA after walking with distraction at preferential speed
Description
[0; 100]
Time Frame
Day 0
Title
EVA after walking without distraction at the speed of 130% of the preferential speed
Description
[0; 100]
Time Frame
Day 0
Title
EVA after walking with distraction at the speed of 130% of the preferential speed
Description
[0; 100]
Time Frame
Day 0
Title
Reaction time to auditory stimuli without distraction at preferential speed
Description
second
Time Frame
Day 0
Title
Reaction time to auditory stimuli with distraction at preferential speed
Description
second
Time Frame
Day 0
Title
Reaction time to auditory stimuli without distraction at the speed of 130% of the preferential speed
Description
second
Time Frame
Day 0
Title
Reaction time to auditory stimuli with distraction at the speed of 130% of the preferential speed
Description
second
Time Frame
Day 0
Title
Tampa Scale for kinesophobia
Description
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
Time Frame
Day 0
Title
Dallas Pain Questionnaire for Back Pain
Description
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.
Time Frame
Day 0
Title
Quebec Back Pain Disability Index
Description
The item scores were summed for a total score between 0 and 100, with higher numbers representing greater levels of disability.
Time Frame
Day 0
Title
Fear Avoidance Belief Questionnaire (FABQ)
Description
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.
Time Frame
Day 0
Title
Hospital and Anxiety Depression Scale
Description
Score: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Dupeyron, Pr
Organizational Affiliation
Centre Hospitalier Universitaire de Nīmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nimes University Hospital
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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Complexity & Distraction in LBP

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