Skip to content

Complexity & Distraction in LBP

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03633578
Acronym
CoDiLoBP
Enrollment
16
Registered
2018-08-16
Start date
2018-04-01
Completion date
2018-05-17
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain, Gait, Motor Activity

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.

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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

* 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)

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Reaction time to auditory stimuli without distraction at preferential speedDay 0second
Reaction time to auditory stimuli with distraction at preferential speedDay 0second
Reaction time to auditory stimuli without distraction at the speed of 130% of the preferential speedDay 0second
Reaction time to auditory stimuli with distraction at the speed of 130% of the preferential speedDay 0second
EVA after walking without distraction at preferential speedDay 0\[0; 100\]
Dallas Pain Questionnaire for Back PainDay 0This 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 IndexDay 0The 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)Day 0The 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 ScaleDay 0Score: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Tampa Scale for kinesophobiaDay 0The 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
EVA after walking with distraction at preferential speedDay 0\[0; 100\]
EVA after walking without distraction at the speed of 130% of the preferential speedDay 0\[0; 100\]
EVA after walking with distraction at the speed of 130% of the preferential speedDay 0\[0; 100\]

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026