Lumbar Proprioception in Lower Back Pain Patients Versus Healthy Subjects : a Comparative Study on the Effects of Low- and High-frequency Muscle Vibrations
Vibrioception
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2013
CompletedFirst Posted
Study publicly available on registry
February 20, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedMarch 26, 2015
March 1, 2015
6 months
February 18, 2013
March 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement erreur
Measures are made with an electronic goniometer. Measurement erreur = (Lumbar angle in the target position) - (lumbar angle in patient-perceived target position)
Baseline (day O)
Study Arms (12)
Healthy volunteers 1
ACTIVE COMPARATORThe 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;
Healthy volunteers 2
ACTIVE COMPARATORThe 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;
Healthy volunteers 3
ACTIVE COMPARATORThe 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;
Healthy volunteers 4
ACTIVE COMPARATORThe 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;
Healthy volunteers 5
ACTIVE COMPARATORThe 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;
Healthy volunteers 6
ACTIVE COMPARATORThe 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;
Back pain patients 1
EXPERIMENTALThe 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;
Back pain patients 2
EXPERIMENTALThe 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;
Back pain patients 3
EXPERIMENTALThe 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;
Back pain patients 4
EXPERIMENTALThe 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;
Back pain patients 5
EXPERIMENTALThe 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;
Back pain patients 6
EXPERIMENTALThe 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;
Interventions
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- The subject must have given his/her informed and signed consent
- The subject must be insured or beneficiary of a health insurance plan
You may not qualify if:
- 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
- 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)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, 30029, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arnaud Dupeyron, MD, PhD
Centre Hospitalier Universitaire de Nîmes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2013
First Posted
February 20, 2013
Study Start
April 1, 2013
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
March 26, 2015
Record last verified: 2015-03