NCT03633578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
Last Updated

November 21, 2025

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

August 14, 2018

Last Update Submit

November 18, 2025

Conditions

Chronic Low Back PainGaitMotor Activity

Outcome Measures

Primary Outcomes (4)

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

    \[0,5; 1,5\]

    Day 0

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

    \[0,5; 1,5\]

    Day 0

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

    \[0,5; 1,5\]

    Day 0

  • 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 Outcomes (13)

  • EVA after walking without distraction at preferential speed

    Day 0

  • EVA after walking with distraction at preferential speed

    Day 0

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

    Day 0

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

    Day 0

  • Reaction time to auditory stimuli without distraction at preferential speed

    Day 0

  • +8 more secondary outcomes

Study Arms (1)

Interventional group

EXPERIMENTAL

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

walk testBEHAVIORAL

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

Interventional group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The subject participates in another interventional 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nimes University Hospital

Nîmes, 30029, France

Location

Related Publications (1)

  • 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.

    PMID: 34001770RESULT

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Arnaud Dupeyron, Pr

    Centre Hospitalier Universitaire de Nīmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2018

First Posted

August 16, 2018

Study Start

April 1, 2018

Primary Completion

May 17, 2018

Study Completion

May 17, 2018

Last Updated

November 21, 2025

Record last verified: 2020-12

Locations

FR(1)