NCT01795443CompletedNot Applicable

Lumbar Proprioception in Lower Back Pain Patients Versus Healthy Subjects : a Comparative Study on the Effects of Low- and High-frequency Muscle Vibrations

Centre Hospitalier Universitaire de Nīmes1 site in 1 country24 target enrollmentStarted: April 1, 2013Last updated: March 26, 2015

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor
Enrollment: 24
Locations: 1
Primary Endpoint: Measurement erreur

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Basic Science
Masking: None

Eligibility Criteria

Ages: 18 Years to 75 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: Yes

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

Arms & Interventions

Healthy volunteers 2

Active Comparator

The patients in this arm of the study are healthy volunteers with no history of back pain in the last five years (see inclusion/exclusion criteria).