Evaluation of Dynamic Stability in the Low Back Pain Patient

NCT ID: NCT02059317

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-09-28

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.

Conditions

Low Back Pain; Chronic Low Back Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Flexion-extension in the sagittal plane

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

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.

Flexion-extension in the sagittal plane

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

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.

Flexion-extension in the sagittal plane

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

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.

Flexion-extension in the sagittal plane

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

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.

Flexion-extension in the sagittal plane

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

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.

Flexion-extension in the sagittal plane

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• The patient has chronic low back pain lasting for more than 6 months and which is not postoperative in nature

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnaud Dupeyron, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 33157419 (View on PubMed)

Other Identifiers

2013-A01379-36

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2013/AD-02

Identifier Type: -

Identifier Source: org_study_id