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CompletedNCT03633578CoDiLoBPUpdated Nov 21, 2025

Complexity & Distraction in LBP

An interventional study of walk test in Chronic Low Back Pain, Gait and Motor Activity, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2018, registered Aug 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Low Back Pain
  • Gait
  • Motor Activity

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03

In context

Motor Activity

2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.

This study's enrollment of 16 is below the median of 60 across 2,118 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • 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

Interventions

  • Behavioralwalk 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

06

What researchers measure

Primary outcomes

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

    \[0,5; 1,5\]

    Time frame: Day 0

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

    \[0,5; 1,5\]

    Time frame: Day 0

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

    \[0,5; 1,5\]

    Time frame: Day 0

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

    \[0,5; 1,5\]

    Time frame: Day 0

Secondary outcomes

  1. EVA after walking without distraction at preferential speed

    \[0; 100\]

    Time frame: Day 0

  2. EVA after walking with distraction at preferential speed

    \[0; 100\]

    Time frame: Day 0

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

    \[0; 100\]

    Time frame: Day 0

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

    \[0; 100\]

    Time frame: Day 0

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

    second

    Time frame: Day 0

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

    second

    Time frame: Day 0

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

    second

    Time frame: Day 0

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

    second

    Time frame: Day 0

  9. 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

    Time frame: Day 0

  10. 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.

    Time frame: Day 0

  11. 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.

    Time frame: Day 0

  12. 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.

    Time frame: Day 0

  13. Hospital and Anxiety Depression Scale

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

    Time frame: Day 0

07

Study locations

1 site
  • Nimes University Hospital
    Nîmes, 30029, France
08

References and documents

Publications

  • Homs AF, Dupeyron A, Torre K. Relationship between gait complexity and pain attention in chronic low back pain. Pain. 2022 Jan 1;163(1):e31-e39. doi: 10.1097/j.pain.0000000000002303. PubMed 34001770 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03633578
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Aug 16, 2018
Start date
Apr 1, 2018
Primary completion
May 17, 2018
Completion
May 17, 2018
Last update
Nov 21, 2025

Study contacts

Arnaud Dupeyron, Pr
principal investigator · Centre Hospitalier Universitaire de Nīmes

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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