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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Chronic Low Back Pain; Low Back Pain

Treatments: Other: Complex movement in three dimensions; Other: Flexion-extension in the sagittal plane; Other: Rotation in a transverse plane

Study type: Observational

Funder types: Other

Identifiers

NCT02059317

2013-A01379-36 (Other Identifier)

LOCAL/2013/AD-02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

70 participants in 6 patient groups

Group 1

Description:

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.

Treatment:

Other: Rotation in a transverse plane

Other: Flexion-extension in the sagittal plane

Other: Complex movement in three dimensions

Group 2

Description:

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.

Treatment:

Other: Rotation in a transverse plane

Other: Flexion-extension in the sagittal plane

Other: Complex movement in three dimensions

Group 3

Description:

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.

Treatment:

Other: Rotation in a transverse plane

Other: Flexion-extension in the sagittal plane

Other: Complex movement in three dimensions

Group 4

Description:

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.

Treatment:

Other: Rotation in a transverse plane

Other: Flexion-extension in the sagittal plane

Other: Complex movement in three dimensions

Group 5

Description:

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.

Treatment:

Other: Rotation in a transverse plane

Other: Flexion-extension in the sagittal plane

Other: Complex movement in three dimensions

Group 6

Description:

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.

Treatment:

Other: Rotation in a transverse plane

Other: Flexion-extension in the sagittal plane

Other: Complex movement in three dimensions