Evaluation of Dynamic Stability in the Low Back Pain Patient

NCT02059317 | Completed

• 2 other identifiers: LOCAL/2013/AD-022013-A01379-36
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Low Back Pain; Chronic Low Back Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (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

• the Lyapunov exponent (lmax, an indicator of local dynamic stability)

  week 6

• the Lyapunov exponent (lmax, an indicator of local dynamic stability)

  day 7

Other Outcomes (4)

• Sex

  baseline (day 0)

• Age

  baseline (day 0)

• weight (kg)

  baseline (day 0)

Study Arms (6)

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.

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.

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.

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.

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.

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.

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

Interventions

Flexion-extension in the sagittal plane 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.

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Rotation in a transverse plane 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.

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Complex movement in three dimensions 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 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• The patient/subject is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 33157419 RESULT

MeSH Terms

Conditions

Low Back Pain

Interventions

Rotation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motion; Physical Phenomena

Study Officials

• Arnaud Dupeyron, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 11, 2014
• Study Start: January 1, 2015
• Primary Completion: September 28, 2016
• Study Completion: September 28, 2016
• Last Updated: November 19, 2025

Record last verified: 2016-09

Locations

FR (1)