Evaluation of Dynamic Stability in the Low Back Pain Patient

Low Back Pain Clinical Trial

— SDL  

Official title:

Evaluation of Dynamic Stability in the Low Back Pain Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059317
• Other study ID #: LOCAL/2013/AD-02
• Secondary ID: 2013-A01379-36
• Status: Completed
• Phase: N/A
• First received: February 6, 2014
• Last updated: January 30, 2017
• Start date: January 2015
• Est. completion date: September 28, 2016

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 28, 2016
• Est. primary completion date: September 20, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sex	(male/female)	baseline (day 0)
Other	Age	(years)	baseline (day 0)
Other	weight (kg)		baseline (day 0)
Other	Height (cm)		baseline (day 0)
Primary	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)
Primary	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)
Primary	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	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 7
Secondary	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.	week 6
Secondary	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 7
Secondary	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.	week 6
Secondary	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 7
Secondary	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.	week 6