Low Back PainSDLNCT02059317
Evaluation of Dynamic Stability in the Low Back Pain Patient
An observational study of Low Back Pain and Chronic Low Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Chronic Low Back Pain
- What is being tested?
- Flexion-extension in the sagittal plane, Rotation in a transverse plane and Complex movement in three dimensions
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to 28 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Low Back Pain, Chronic Low Back Pain
- Being tested
- Flexion-extension in the sagittal plane, Rotation in a transverse plane, Complex movement in three dimensions
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexion-extension in the sagittal planeOther
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 planeOther
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 dimensionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 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. Receives: Other: Flexion-extension in the sagittal plane; Other: Rotation in a transverse plane; Other: Complex movement in three dimensions | |
| Group 2 | 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. Receives: Other: Flexion-extension in the sagittal plane; Other: Rotation in a transverse plane; Other: Complex movement in three dimensions | |
| Group 3 | 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. Receives: Other: Flexion-extension in the sagittal plane; Other: Rotation in a transverse plane; Other: Complex movement in three dimensions | |
| Group 4 | 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. Receives: Other: Flexion-extension in the sagittal plane; Other: Rotation in a transverse plane; Other: Complex movement in three dimensions | |
| Group 5 | 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. Receives: Other: Flexion-extension in the sagittal plane; Other: Rotation in a transverse plane; Other: Complex movement in three dimensions | |
| Group 6 | 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. Receives: Other: Flexion-extension in the sagittal plane; Other: Rotation in a transverse plane; Other: Complex movement in three dimensions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 0 (baseline)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startJan 2015
- Primary completion28 Sep 2016
- Study completion28 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Dupeyron, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059317
- Sponsor's protocol ID
- LOCAL/2013/AD-02
- Other IDs
- 2013-A01379-36
- Acronym
- SDL
- Status last verified
- Sep 2016
- First submitted
- 6 Feb 2014
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 33157419
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dynamic Stability in the Low Back Pain Patient
- ClinicalTrials.gov ID
- NCT02059317
- Acronym / sponsor ID
- SDL / LOCAL/2013/AD-02
- Conditions
- Low Back Pain, Chronic Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 28 Sep 2016 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Flexion-extension in the sagittal plane, Other: Rotation in a transverse plane, Other: Complex movement in three dimensionsSix 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. |
| Group 2 | – | Other: Flexion-extension in the sagittal plane, Other: Rotation in a transverse plane, Other: Complex movement in three dimensionsSix 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. |
| Group 3 | – | Other: Flexion-extension in the sagittal plane, Other: Rotation in a transverse plane, Other: Complex movement in three dimensionsSix 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. |
| Group 4 | – | Other: Flexion-extension in the sagittal plane, Other: Rotation in a transverse plane, Other: Complex movement in three dimensionsSix 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. |
| Group 5 | – | Other: Flexion-extension in the sagittal plane, Other: Rotation in a transverse plane, Other: Complex movement in three dimensionsSix 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. |
| Group 6 | – | Other: Flexion-extension in the sagittal plane, Other: Rotation in a transverse plane, Other: Complex movement in three dimensionsSix 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- The patient has chronic low back pain lasting for more than 6 months and which is not postoperative in nature
- 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
Key exclusion criteria (5 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexion-extension in the sagittal planeThe 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 | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Rotation in a transverse planeThe 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 | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Complex movement in three dimensionsThe 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. | Other | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
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.
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.
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.
6 secondary outcomes
the Lyapunov exponent (lmax, an indicator of local dynamic stability)
Time frame: day 7
the Lyapunov exponent (lmax, an indicator of local dynamic stability)
Time frame: week 6
the Lyapunov exponent (lmax, an indicator of local dynamic stability)
Time frame: day 7
the Lyapunov exponent (lmax, an indicator of local dynamic stability)
Time frame: week 6
the Lyapunov exponent (lmax, an indicator of local dynamic stability)
Time frame: day 7
the Lyapunov exponent (lmax, an indicator of local dynamic stability)
Time frame: week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 33157419Graham 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Dupeyron, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Chronic Low Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Lyapunov exponent (lmax, an indicator of local dynamic stability) (time frame: Day 0 (baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02059317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.