NCT02059317|Completed
Evaluation of Dynamic Stability in the Low Back Pain Patient
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Sponsor study identifier
Secondary identifiers
OTHER · ANSM
observational
70
1 country
1
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 28, 2016
Actual (reported)Study Completion
September 28, 2016
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 28, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 6, 2014
Actual (reported)February 11, 2014
Actual (reported)January 2015
Date type not reportedThis date has not been verified as actual or estimated.
September 28, 2016
Actual (reported)September 28, 2016
Actual (reported)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)
the Lyapunov exponent (lmax, an indicator of local dynamic stability)
day 7
the Lyapunov exponent (lmax, an indicator of local dynamic stability)
week 6
the Lyapunov exponent (lmax, an indicator of local dynamic stability)
day 7
the Lyapunov exponent (lmax, an indicator of local dynamic stability)
week 6
the Lyapunov exponent (lmax, an indicator of local dynamic stability)
day 7
Sex
baseline (day 0)
Age
baseline (day 0)
weight (kg)
baseline (day 0)
Six groups are created in order to randomized the order of interventions. In group 1, the order of interventions is as follows: 1. Flexion-extension in the sagittal plane 2. Rotation in a transverse plane 3. 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.
Six groups are created in order to randomized the order of interventions. In group 2, the order of interventions is as follows: 1. Flexion-extension in the sagittal plane 2. Complex movement in three dimensions 3. 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.
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.
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.
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
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.
Arnaud Dupeyron, MD, PhD
Centre Hospitalier Universitaire de Nīmes
70 participants (actual enrollment reported by the registry).
First Submitted
February 6, 2014
First Posted
February 11, 2014
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome
Six groups are created in order to randomized the order of interventions. In group 3, the order of interventions is as follows: 1. Rotation in a transverse plane 2. Flexion-extension in the sagittal plane 3. 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.
Six groups are created in order to randomized the order of interventions. In group 4, the order of interventions is as follows: 1. Rotation in a transverse plane 2. Complex movement in three dimensions 3. 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.
Six groups are created in order to randomized the order of interventions. In group 5, the order of interventions is as follows: 1. Complex movement in three dimensions 2. Flexion-extension in the sagittal plane 3. 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.
Six groups are created in order to randomized the order of interventions. In group 6, the order of interventions is as follows: 1. Complex movement in three dimensions 2. Rotation in a transverse plane 3. 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.
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.
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.
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Primary Completion
September 28, 2016
Actual (reported)Study Completion
September 28, 2016
Actual (reported)Last Updated
November 19, 2025
Record last verified: 2016-09
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