Clinical trial NCT02059317: Evaluation of Dynamic Stability in the Low Back Pain Patient
Official title: Evaluation of Dynamic Stability in the Low Back Pain Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Chronic Low Back Pain
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited during consultations in the department of Physical Medicine and Rehabilitation at the Nîmes University Hospital for lower back (lumbar) pain. The study population will include patients with chronic low back pain (lasting for more than 6 months and not postoperative).

Healthy volunteers will be recruited at the Faculty of Medicine and the University Hospital of Nîmes.

Brief summary: The main objective of this study is to compare on day 0 the maximum Lyapunov exponent (lmax, an indicator of local dynamic stability) of chronic low back pain patients versus that of healthy volunteers matched for age (± 5 years), sex and body mass index (BMI ± 15% of low back pain patients).

Detailed description: The secondary objectives of this study are:

To compare lmax in the different experimental conditions within each group (chronic lower back pain patients, healthy volunteers).

To compare changes in lmax for low back pain patients at D7 and 6 weeks.

Eligibility criteria: General inclusion criteria:

* The patient/subject must have given his/her informed and signed consent
* The patient/subject must be insured or beneficiary of a health insurance plan

Inclusion criteria for low back pain patients:

* The patient has chronic low back pain lasting for more than 6 months and which is not postoperative in nature

General exclusion criteria:

* The patient/subject is participating in another study
* The patient/subject is in an exclusion period determined by a previous study
* The patient/subject is under judicial protection, under tutorship or curatorship
* The patient/subject refuses to sign the consent
* It is impossible to correctly inform the patient/subject
* The patient/subject is pregnant, parturient, or breastfeeding

Exclusion criteria for low back pain patients:

* The patient has a history of spinal surgery
* The patient has a history of preexisting postural disorder related to lumbalgia
* The patient has undergone a localized infiltration treatment (e.g. cortisone shots) in the last month
* The subject has a balance disorder, blindness, inability to carry out the experimental protocol

Exclusion criteria for healthy volunteers:

* The subject has a history of acute low back pain \> 15 days or which has resulted in a work stoppage of more than 7 days in the 5 years preceding the study

Primary outcomes:
measure: the Lyapunov exponent (lmax, an indicator of local dynamic stability)
timeFrame: Day 0 (baseline)
measure: the Lyapunov exponent (lmax, an indicator of local dynamic stability)
timeFrame: Day 0 (baseline)
measure: the Lyapunov exponent (lmax, an indicator of local dynamic stability)
timeFrame: Day 0 (baseline)
Secondary outcomes:
measure: the Lyapunov exponent (lmax, an indicator of local dynamic stability)
timeFrame: day 7
measure: the Lyapunov exponent (lmax, an indicator of local dynamic stability)
timeFrame: week 6
measure: the Lyapunov exponent (lmax, an indicator of local dynamic stability)
timeFrame: day 7
measure: the Lyapunov exponent (lmax, an indicator of local dynamic stability)
timeFrame: week 6
measure: the Lyapunov exponent (lmax, an indicator of local dynamic stability)
timeFrame: day 7
measure: the Lyapunov exponent (lmax, an indicator of local dynamic stability)
timeFrame: week 6
Other outcomes:
measure: Sex
timeFrame: baseline (day 0)
measure: Age
timeFrame: baseline (day 0)
measure: weight (kg)
timeFrame: baseline (day 0)
measure: Height (cm)
timeFrame: baseline (day 0)
Locations:
city: Nîmes Cedex
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Arnaud Dupeyron, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: