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

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Back Pain

Treatments

Other: Measures - low vibration
Other: Measures - high vibration
Other: Calibration
Other: Measures - no vibration
Other: Practice

Study type

Interventional

Funder types

Other

Identifiers

NCT01795443
2012-A01733-40 (Other Identifier)
LOCAL/2012/AD-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 12 patient groups

Healthy volunteers 1
Active Comparator group
Description:
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). Propioception measures will be carried out in the following order: Intervention: Calibration; Intervention: Practice; Intervention: Measures - no vibration; Intervention: Measures - high vibration; Intervention: Measures - low vibration;
Treatment:
Other: Practice
Other: Calibration
Other: Measures - low vibration
Other: Measures - no vibration
Other: Measures - high vibration
Healthy volunteers 2
Active Comparator group
Description:
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). Propioception measures will be carried out in the following order: Intervention: Calibration; Intervention: Practice; Intervention: Measures - no vibration; Intervention: Measures - low vibration; Intervention: Measures - high vibration;
Treatment:
Other: Practice
Other: Calibration
Other: Measures - low vibration
Other: Measures - no vibration
Other: Measures - high vibration
Healthy volunteers 3
Active Comparator group
Description:
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). Propioception measures will be carried out in the following order: Intervention: Calibration; Intervention: Practice; Intervention: Measures - high vibration; Intervention: Measures - no vibration; Intervention: Measures - low vibration;
Treatment:
Other: Practice
Other: Calibration
Other: Measures - low vibration
Other: Measures - no vibration
Other: Measures - high vibration
Healthy volunteers 4
Active Comparator group
Description:
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). Propioception measures will be carried out in the following order: Intervention: Calibration; Intervention: Practice; Intervention: Measures - high vibration; Intervention: Measures - low vibration; Intervention: Measures - no vibration;
Treatment:
Other: Practice
Other: Calibration
Other: Measures - low vibration
Other: Measures - no vibration
Other: Measures - high vibration
Healthy volunteers 5
Active Comparator group
Description:
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). Propioception measures will be carried out in the following order: Intervention: Calibration; Intervention: Practice; Intervention: Measures - low vibration; Intervention: Measures - no vibration; Intervention: Measures - high vibration;
Treatment:
Other: Practice
Other: Calibration
Other: Measures - low vibration
Other: Measures - no vibration
Other: Measures - high vibration
Healthy volunteers 6
Active Comparator group
Description:
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). Propioception measures will be carried out in the following order: Intervention: Calibration; Intervention: Practice; Intervention: Measures - low vibration; Intervention: Measures - high vibration; Intervention: Measures - no vibration;
Treatment:
Other: Practice
Other: Calibration
Other: Measures - low vibration
Other: Measures - no vibration
Other: Measures - high vibration
Back pain patients 1
Experimental group
Description:
The patients included in this arm have had back pain for at least 6 months; the origin of this back pain can not be from a previous surgery (see inclusion and exclusion criteria). Propioception measures will be carried out in the following order: Intervention: Calibration; Intervention: Practice; Intervention: Measures - no vibration; Intervention: Measures - high vibration; Intervention: Measures - low vibration;
Treatment:
Other: Practice
Other: Calibration
Other: Measures - low vibration
Other: Measures - no vibration
Other: Measures - high vibration
Back pain patients 2
Experimental group
Description:
The patients included in this arm have had back pain for at least 6 months; the origin of this back pain can not be from a previous surgery (see inclusion and exclusion criteria). Propioception measures will be carried out in the following order: Intervention: Calibration; Intervention: Practice; Intervention: Measures - no vibration; Intervention: Measures - low vibration; Intervention: Measures - high vibration;
Treatment:
Other: Practice
Other: Calibration
Other: Measures - low vibration
Other: Measures - no vibration
Other: Measures - high vibration
Back pain patients 3
Experimental group
Description:
The patients included in this arm have had back pain for at least 6 months; the origin of this back pain can not be from a previous surgery (see inclusion and exclusion criteria). Propioception measures will be carried out in the following order: Intervention: Calibration; Intervention: Practice; Intervention: Measures - high vibration; Intervention: Measures - no vibration; Intervention: Measures - low vibration;
Treatment:
Other: Practice
Other: Calibration
Other: Measures - low vibration
Other: Measures - no vibration
Other: Measures - high vibration
Back pain patients 4
Experimental group
Description:
The patients included in this arm have had back pain for at least 6 months; the origin of this back pain can not be from a previous surgery (see inclusion and exclusion criteria). Propioception measures will be carried out in the following order: Intervention: Calibration; Intervention: Practice; Intervention: Measures - high vibration; Intervention: Measures - low vibration; Intervention: Measures - no vibration;
Treatment:
Other: Practice
Other: Calibration
Other: Measures - low vibration
Other: Measures - no vibration
Other: Measures - high vibration
Back pain patients 5
Experimental group
Description:
The patients included in this arm have had back pain for at least 6 months; the origin of this back pain can not be from a previous surgery (see inclusion and exclusion criteria). Propioception measures will be carried out in the following order: Intervention: Calibration; Intervention: Practice; Intervention: Measures - low vibration; Intervention: Measures - no vibration; Intervention: Measures - high vibration;
Treatment:
Other: Practice
Other: Calibration
Other: Measures - low vibration
Other: Measures - no vibration
Other: Measures - high vibration
Back pain patients 6
Experimental group
Description:
The patients included in this arm have had back pain for at least 6 months; the origin of this back pain can not be from a previous surgery (see inclusion and exclusion criteria). Propioception measures will be carried out in the following order: Intervention: Calibration; Intervention: Practice; Intervention: Measures - low vibration; Intervention: Measures - high vibration; Intervention: Measures - no vibration;
Treatment:
Other: Practice
Other: Calibration
Other: Measures - low vibration
Other: Measures - no vibration
Other: Measures - high vibration

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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