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Completed

NCT Number: NCT03633578

Complexity & Distraction in LBP

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.

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Key information

Conditions

Chronic Low Back Pain Behavior Gait Motor Activity

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nimes University Hospital

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

walk test

Behavioral

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 outcomes

  1. Estimation of the fractal exponent when walking without distraction at preferential speed

    Time frame: Day 0

    [0,5; 1,5]

  2. Estimation of the fractal exponent when walking with distraction at preferential speed

    Time frame: Day 0

    [0,5; 1,5]

  3. Estimation of the fractal exponent when walking without distraction at the speed of 130% of the preferential speed

    Time frame: Day 0

    [0,5; 1,5]

  4. Estimation of the fractal exponent when walking with distraction at the speed of 130% of the preferential speed

    Time frame: Day 0

    [0,5; 1,5]

Secondary outcomes

  1. EVA after walking without distraction at preferential speed

    Time frame: Day 0

    [0; 100]

  2. EVA after walking with distraction at preferential speed

    Time frame: Day 0

    [0; 100]

  3. EVA after walking without distraction at the speed of 130% of the preferential speed

    Time frame: Day 0

    [0; 100]

  4. EVA after walking with distraction at the speed of 130% of the preferential speed

    Time frame: Day 0

    [0; 100]

  5. Reaction time to auditory stimuli without distraction at preferential speed

    Time frame: Day 0

    second

  6. Reaction time to auditory stimuli with distraction at preferential speed

    Time frame: Day 0

    second

  7. Reaction time to auditory stimuli without distraction at the speed of 130% of the preferential speed

    Time frame: Day 0

    second

  8. Reaction time to auditory stimuli with distraction at the speed of 130% of the preferential speed

    Time frame: Day 0

    second

  9. Tampa Scale for kinesophobia

    Time frame: Day 0

    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

  10. Dallas Pain Questionnaire for Back Pain

    Time frame: Day 0

    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.

  11. Quebec Back Pain Disability Index

    Time frame: Day 0

    The item scores were summed for a total score between 0 and 100, with higher numbers representing greater levels of disability.

  12. Fear Avoidance Belief Questionnaire (FABQ)

    Time frame: Day 0

    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.

  13. Hospital and Anxiety Depression Scale

    Time frame: Day 0

    Score:

    0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: CoDiLoBP

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2018
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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