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Evaluation of Dynamic Stability in the Low Back Pain Patient

Evaluation of Dynamic Stability in the Low Back Pain Patient

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02059317
Acronym
SDL
Enrollment
70
Registered
2014-02-11
Start date
2015-01-31
Completion date
2016-09-28
Last updated
2025-11-19

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

Conditions

Chronic Low Back Pain, Low Back Pain

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.

Interventions

OTHERFlexion-extension in the sagittal plane

The movement required is a flexion - extension where the subject touches a target (adapted to his/her morphology) with both index fingers: the target is positioned in front of the subject, inline with his/her outstretched arms and at knee height. This movement simulates a lifting task without weight. The movement is repeated 30 times with a return to the initial position at a frequency of 0.32Hz.

OTHERRotation in a transverse plane

The movement required of the subject is a rotational movement where the subject alternately touches with his/her left and right hands two targets. The latter are positioned horizontally on either side of the subject at shoulder height and at arm's length. The movement is repeated 30 times at a frequency of 0.28 Hz.

OTHERComplex movement in three dimensions

The subject is required to successively touch 4 targets situated (i) at knee height to the left of the subject, (ii) at shoulder height to the right of the subject, (iii) at shoulder height to the left of the patient, and (iv) at knee height to the right of the patient. The movement is repeated 30 times at a frequency of 0.16 Hz.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
the Lyapunov exponent (lmax, an indicator of local dynamic stability)Day 0 (baseline)for flexion-extension movements The maximum Lyapunov exponent (lmax) is used to characterise local dynamic stability as in Rosenstein et al 1993 and Dingwell & Kang 2007.

Secondary

MeasureTime frameDescription
the Lyapunov exponent (lmax, an indicator of local dynamic stability)day 7for flexion-extension movements. The maximum Lyapunov exponent (lmax) is used to characterise local dynamic stability as in Rosenstein et al 1993 and Dingwell & Kang 2007.

Other

MeasureTime frameDescription
Sexbaseline (day 0)(male/female)
Agebaseline (day 0)(years)
weight (kg)baseline (day 0)
Height (cm)baseline (day 0)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026