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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT02059317
First received: February 6, 2014
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention
Low Back Pain
Chronic Low Back Pain
Other: Flexion-extension in the sagittal plane
Other: Rotation in a transverse plane
Other: Complex movement in three dimensions

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Dynamic Stability in the Low Back Pain Patient

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • the Lyapunov exponent (lmax, an indicator of local dynamic stability) [ Time Frame: Day 0 (baseline) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • the Lyapunov exponent (lmax, an indicator of local dynamic stability) [ Time Frame: day 7 ] [ Designated as safety issue: No ]

    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: week 6 ] [ Designated as safety issue: No ]

    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 7 ] [ Designated as safety issue: No ]

    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: week 6 ] [ Designated as safety issue: No ]

    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 7 ] [ Designated as safety issue: No ]

    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.


  • the Lyapunov exponent (lmax, an indicator of local dynamic stability) [ Time Frame: week 6 ] [ Designated as safety issue: No ]

    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.



Other Outcome Measures:
  • Sex [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
    (male/female)

  • Age [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
    (years)

  • weight (kg) [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Height (cm) [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2015
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.
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.
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.
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
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.
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.
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.
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
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.
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.
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.
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
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.
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.
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.
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
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.
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.
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.
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
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059317

Contacts
Contact: Arnaud Dupeyron, MD, PHD +33.(0)4.66.68.39.20 arnaud.dupeyron@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHRU de Nîmes - Hôpital Universitaire Carémeau Not yet recruiting
Nîmes Cedex, France, 30029
Principal Investigator: Arnaud Dupeyron, MD, PhD         
Sub-Investigator: Claire de la Bachelerie, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Arnaud Dupeyron, MD, PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02059317     History of Changes
Other Study ID Numbers: LOCAL/2013/AD-02, 2013-A01379-36
Study First Received: February 6, 2014
Last Updated: March 3, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014