Evaluation of Dynamic Stability in the Low Back Pain Patient (SDL)

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).

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Chronic Low Back Pain
• Intervention / Treatment: Other: Flexion-extension in the sagittal plane; Other: Rotation in a transverse plane; Other: Complex movement in three dimensions

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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Six groups are created in order to randomized the order of interventions. In group 1, the order of interventions is as follows: Flexion-extension in the sagittal plane; Rotation in a transverse plane; Complex movement in three dimensions 2 minutes of rest and walking occurs between interventions. The above-mentioned exercises (1, 2 & 3) are performed on day 0, day 7 and week 6 for patients, and only on day 0 for healthy volunteers.	Other: Flexion-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.; Other: Rotation 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.; Other: Complex 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.
Group 2; Six groups are created in order to randomized the order of interventions. In group 2, the order of interventions is as follows: Flexion-extension in the sagittal plane; Complex movement in three dimensions; Rotation in a transverse plane 2 minutes of rest and walking occurs between interventions. The above-mentioned exercises (1, 2 & 3) are performed on day 0, day 7 and week 6 for patients, and only on day 0 for healthy volunteers.	Other: Flexion-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.; Other: Rotation 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.; Other: Complex 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.
Group 3; Six groups are created in order to randomized the order of interventions. In group 3, the order of interventions is as follows: Rotation in a transverse plane; Flexion-extension in the sagittal plane; Complex movement in three dimensions 2 minutes of rest and walking occurs between interventions. The above-mentioned exercises (1, 2 & 3) are performed on day 0, day 7 and week 6 for patients, and only on day 0 for healthy volunteers.	Other: Flexion-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.; Other: Rotation 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.; Other: Complex 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.
Group 4; Six groups are created in order to randomized the order of interventions. In group 4, the order of interventions is as follows: Rotation in a transverse plane; Complex movement in three dimensions; Flexion-extension in the sagittal plane 2 minutes of rest and walking occurs between interventions. The above-mentioned exercises (1, 2 & 3) are performed on day 0, day 7 and week 6 for patients, and only on day 0 for healthy volunteers.	Other: Flexion-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.; Other: Rotation 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.; Other: Complex 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.
Group 5; Six groups are created in order to randomized the order of interventions. In group 5, the order of interventions is as follows: Complex movement in three dimensions; Flexion-extension in the sagittal plane; Rotation in a transverse plane 2 minutes of rest and walking occurs between interventions. The above-mentioned exercises (1, 2 & 3) are performed on day 0, day 7 and week 6 for patients, and only on day 0 for healthy volunteers.	Other: Flexion-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.; Other: Rotation 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.; Other: Complex 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.
Group 6; Six groups are created in order to randomized the order of interventions. In group 6, the order of interventions is as follows: Complex movement in three dimensions; Rotation in a transverse plane; Flexion-extension in the sagittal plane 2 minutes of rest and walking occurs between interventions. The above-mentioned exercises (1, 2 & 3) are performed on day 0, day 7 and week 6 for patients, and only on day 0 for healthy volunteers.	Other: Flexion-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.; Other: Rotation 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.; Other: Complex 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Lyapunov exponent (lmax, an indicator of local dynamic stability)	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.	Day 0 (baseline)
the Lyapunov exponent (lmax, an indicator of local dynamic stability)	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.	Day 0 (baseline)
the Lyapunov exponent (lmax, an indicator of local dynamic stability)	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.	Day 0 (baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Lyapunov exponent (lmax, an indicator of local dynamic stability)	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.	day 7
the Lyapunov exponent (lmax, an indicator of local dynamic stability)	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.	week 6
the Lyapunov exponent (lmax, an indicator of local dynamic stability)	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.	day 7
the Lyapunov exponent (lmax, an indicator of local dynamic stability)	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.	week 6
the Lyapunov exponent (lmax, an indicator of local dynamic stability)	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.	day 7
the Lyapunov exponent (lmax, an indicator of local dynamic stability)	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.	week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex	(male/female)	baseline (day 0)
Age	(years)	baseline (day 0)
weight (kg)		baseline (day 0)
Height (cm)		baseline (day 0)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Arnaud Dupeyron, MD, PhD, Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• Graham RB, Dupeyron A, van Dieen JH. Between-day reliability of IMU-derived spine control metrics in patients with low back pain. J Biomech. 2020 Dec 2;113:110080. doi: 10.1016/j.jbiomech.2020.110080. Epub 2020 Oct 23.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 28, 2016
• Study Completion (Actual): September 28, 2016

Study Registration Dates

• First Submitted: February 6, 2014
• First Submitted That Met QC Criteria: February 7, 2014
• First Posted (Estimated): February 11, 2014

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain; Physical Phenomena; Motion; Rotation
• Other Study ID Numbers: LOCAL/2013/AD-02; 2013-A01379-36 (Other Identifier: ANSM)