Clinical trial NCT01795443: Lumbar Proprioception in Lower Back Pain Patients Versus Healthy Subjects : a Comparative Study on the Effects of Low- and High-frequency Muscle Vibrations
Official title: Lumbar Proprioception in Lower Back Pain Patients Versus Healthy Subjects : a Comparative Study on the Effects of Low- and High-frequency Muscle Vibrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Keywords: vibration
proprioception
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of this study is to compare the lumbar proprioception of patients with chronic back pain to that of healthy volunteers during low- and high-frequency muscle vibration.

The order of measures (low frequency of vibration, high frequency vibration and no vibration) is randomized in a cross-over design.

Patients and volunteers are matched by age and body mass index.

Detailed description: The secondary objectives of this study are:

A-Measure the effect of low- and high-frequency vibrations on lumbar repositioning in patients with chronic lower back pain.

B-Measure the effect of low- and high-frequency vibrations on lumbar repositioning in healthy volunteers.

Our working hypothesis is that low frequency vibrations induce an illusion of shortening, and high frequency vibrations induce an illusion of elongation. The variability of the error should not increase.

Eligibility criteria: Inclusion Criteria for patients:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has had chronic low back pain (which did NOT originate in a postoperative setting) for at least 6 months

Inclusion Criteria for healthy volunteers:

* The subject must have given his/her informed and signed consent
* The subject must be insured or beneficiary of a health insurance plan

Exclusion Criteria for patients:

* The patient is under judicial protection, or any kind of guardianship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient has a history of spinal surgery
* The patient has a history of preexisting postural disorder preceding low back pain
* The patient has been treated in the last month (e.g. back pain injections)
* The patient has a balance disorder, blindness, inability to perform the experimental protocol

Exclusion Criteria for healthy volunteers:

* The subject is under judicial protection, or any kind of guardianship
* The subject refuses to sign the consent
* It is impossible to correctly inform the subject
* The subject is pregnant, parturient, or breastfeeding
* The subject has a history of spinal surgery
* The subject has a history of preexisting postural disorder preceding low back pain
* The subject has been treated in the last month (e.g. back pain injections)
* The subject has a balance disorder, blindness, inability to perform the experimental protocol
* The subject has a history of acute low back pain \> 15 days or which has resulted in leave from work for more than 7 days in the 5 years preceding the study

Primary outcomes:
measure: Measurement erreur
timeFrame: Baseline (day O)
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Arnaud Dupeyron, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: