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Completed

NCT Number: NCT02059317

Evaluation of Dynamic Stability in the Low Back Pain Patient

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).

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Key information

Conditions

Low Back Pain Back Pain Chronic Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flexion-extension in the sagittal plane

Other

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.

Rotation in a transverse plane

Other

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.

Complex movement in three dimensions

Other

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.

Primary outcomes

  1. the Lyapunov exponent (lmax, an indicator of local dynamic stability)

    Time frame: 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.

  2. the Lyapunov exponent (lmax, an indicator of local dynamic stability)

    Time frame: Day 0 (baseline)

    for rotational movements.

    The maximum Lyapunov exponent (lmax) is used to characterise local dynamic stability as in Rosenstein et al 1993 and Dingwell & Kang 2007.

  3. the Lyapunov exponent (lmax, an indicator of local dynamic stability)

    Time frame: Day 0 (baseline)

    for complex movements.

    The maximum Lyapunov exponent (lmax) is used to characterise local dynamic stability as in Rosenstein et al 1993 and Dingwell & Kang 2007.

Secondary outcomes

  1. the Lyapunov exponent (lmax, an indicator of local dynamic stability)

    Time frame: day 7

    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.

  2. the Lyapunov exponent (lmax, an indicator of local dynamic stability)

    Time frame: week 6

    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.

  3. the Lyapunov exponent (lmax, an indicator of local dynamic stability)

    Time frame: day 7

    for rotational movements.

    The maximum Lyapunov exponent (lmax) is used to characterise local dynamic stability as in Rosenstein et al 1993 and Dingwell & Kang 2007.

  4. the Lyapunov exponent (lmax, an indicator of local dynamic stability)

    Time frame: week 6

    for rotational movements.

    The maximum Lyapunov exponent (lmax) is used to characterise local dynamic stability as in Rosenstein et al 1993 and Dingwell & Kang 2007.

  5. the Lyapunov exponent (lmax, an indicator of local dynamic stability)

    Time frame: day 7

    for complex movements.

    The maximum Lyapunov exponent (lmax) is used to characterise local dynamic stability as in Rosenstein et al 1993 and Dingwell & Kang 2007.

  6. the Lyapunov exponent (lmax, an indicator of local dynamic stability)

    Time frame: week 6

    for complex movements.

    The maximum Lyapunov exponent (lmax) is used to characterise local dynamic stability as in Rosenstein et al 1993 and Dingwell & Kang 2007.

Other outcomes

  1. Sex

    Time frame: baseline (day 0)

    (male/female)

  2. Age

    Time frame: baseline (day 0)

    (years)

  3. weight (kg)

    Time frame: baseline (day 0)

  4. Height (cm)

    Time frame: baseline (day 0)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: SDL

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 11, 2014
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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