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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)

Primary Purpose

Back Pain

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Calibration

Practice

Measures - no vibration

Measures - low vibration

Measures - high vibration

About this trial

This is an interventional basic science trial for Back Pain focused on measuring vibration, proprioception

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CHU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Active Comparator

Experimental

Arm Label

Healthy volunteers 1

Healthy volunteers 2

Healthy volunteers 3

Healthy volunteers 4

Healthy volunteers 5

Healthy volunteers 6

Back pain patients 1

Back pain patients 2

Back pain patients 3

Back pain patients 4

Back pain patients 5

Back pain patients 6

Arm 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;

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;

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;

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;

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;

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;

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;

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;

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;

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;

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;

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;

Outcomes

Primary Outcome Measures

Measurement erreur

Measures are made with an electronic goniometer. Measurement erreur = (Lumbar angle in the target position) - (lumbar angle in patient-perceived target position)

Secondary Outcome Measures

Full Information

NCT ID

NCT01795443

First Posted

February 18, 2013

Last Updated

March 25, 2015

Sponsor

Centre Hospitalier Universitaire de Nīmes

1. Study Identification

Unique Protocol Identification Number

NCT01795443

Brief Title

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

Acronym

Vibrioception

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

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Back Pain

Keywords

vibration, proprioception

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy volunteers 1

Arm Type

Active Comparator

Arm Description

Arm Title

Healthy volunteers 2

Arm Type

Active Comparator

Arm 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;

Arm Title

Healthy volunteers 3

Arm Type

Active Comparator

Arm 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;

Arm Title

Healthy volunteers 4

Arm Type

Active Comparator

Arm 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;

Arm Title

Healthy volunteers 5

Arm Type

Active Comparator

Arm 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;

Arm Title

Healthy volunteers 6

Arm Type

Active Comparator

Arm 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;

Arm Title

Back pain patients 1

Arm Type

Experimental

Arm Description

Arm Title

Back pain patients 2

Arm Type

Experimental

Arm 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;

Arm Title

Back pain patients 3

Arm Type

Experimental

Arm 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;

Arm Title

Back pain patients 4

Arm Type

Experimental

Arm 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;

Arm Title

Back pain patients 5

Arm Type

Experimental

Arm 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;

Arm Title

Back pain patients 6

Arm Type

Experimental

Arm 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;

Intervention Type

Other

Intervention Name(s)

Calibration

Intervention Description

Subjects will be seated on a table, feet dangling, blindfolded, arms crossed over the chest and held in place by bandages to minimize the visual and proprioceptive inputs that may contribute to the realization of the task. The investigator uses an electronic goniometer to measure the maximal extension and flexion during a pelvic pivot. These measures will be used to determine a "target" position midway along the pelvic movement range.

Intervention Type

Other

Intervention Name(s)

Practice

Intervention Description

Propioception test: The movement required is flexion - extension of the lumbar spine without moving the shoulders; it is a pelvic rocking motion. The patients will be helped to the target position by the investigator. After keeping the target position for 5 seconds, they will be asked to completely pivot the pelvis to a forward position, then return to the target position. Each subject will have three (non-measured) tries at the proprioception test without vibration, then three tries with low frequency vibration (20 Hertz), and then three tries with high frequency vibration (60 Hertz). Between each series of tries, a 2-minute rest period with walking is required.

Intervention Type

Other

Intervention Name(s)

Measures - no vibration

Intervention Description

The movements required are performed without vibration. The movement required is flexion - extension of the lumbar spine without moving the shoulders; it is a pelvic rocking motion. The patients will be helped to the target position by the investigator. After keeping the target position for 5 seconds, they will be asked to completely pivot the pelvis to a forward position, then return to the target position. This test is repeated five times. The investigator measures the lumbar angle using an electronic goniometer twice during each of the five tests: once after the patient is helped to the target angle, and once after the patient tries to "remember" the target angle by his/herself.

Intervention Type

Other

Intervention Name(s)

Measures - low vibration

Intervention Description

The movements required are performed with low frequency vibration (20 Hertz on following device: VIBRALGIC 5; manufacturer = Electronique Conseil). The movement required is flexion - extension of the lumbar spine without moving the shoulders; it is a pelvic rocking motion. The patients will be helped to the target position by the investigator. After keeping the target position for 5 seconds, they will be asked to completely pivot the pelvis to a forward position, then return to the target position. This test is repeated five times. The investigator measures the lumbar angle using an electronic goniometer twice during each of the five tests: once after the patient is helped to the target angle, and once after the patient tries to "remember" the target angle by his/herself.

Intervention Type

Other

Intervention Name(s)

Measures - high vibration

Intervention Description

Primary Outcome Measure Information:

Title

Measurement erreur

Description

Measures are made with an electronic goniometer. Measurement erreur = (Lumbar angle in the target position) - (lumbar angle in patient-perceived target position)

Time Frame

Baseline (day O)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arnaud Dupeyron, MD, PhD

Organizational Affiliation

Centre Hospitalier Universitaire de Nîmes

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Nîmes - Hôpital Universitaire Carémeau

City

Nîmes Cedex 09

State/Province

Gard

ZIP/Postal Code

30029

Country

France

12. IPD Sharing Statement

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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

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