Complexity & Distraction in LBP

NCT ID: NCT03633578

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-05-17

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Low Back Pain Gait Motor Activity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

walk test

Intervention Type 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

Interventions

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walk 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnaud Dupeyron, Pr

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nīmes

Locations

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Nimes University Hospital

Nîmes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 34001770 (View on PubMed)

Other Identifiers

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2017-A02839-44

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2017/AH-01

Identifier Type: -

Identifier Source: org_study_id

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