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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01733-40 | Other Identifier | RCB number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers 1 | 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). 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; |
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| 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). 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; |
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| Healthy volunteers 3 | 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). 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; |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calibration | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria for patients:
Inclusion Criteria for healthy volunteers:
Exclusion Criteria for patients:
Exclusion Criteria for healthy volunteers:
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| Name | Affiliation | Role |
|---|---|---|
| Arnaud Dupeyron, MD, PhD | Centre Hospitalier Universitaire de NÄ«mes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | Gard | 30029 | France |
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| Healthy volunteers 4 | 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). 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; |
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| Healthy volunteers 5 | 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). 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; |
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| Healthy volunteers 6 | 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). 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; |
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| Back pain patients 1 | Experimental | 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; |
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| Back pain patients 2 | Experimental | 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; |
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| Back pain patients 3 | Experimental | 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; |
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| Back pain patients 4 | Experimental | 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; |
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| Back pain patients 5 | Experimental | 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; |
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| Back pain patients 6 | Experimental | 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; |
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| Practice | Other | 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. |
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| Measures - no vibration | Other | 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. |
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| Measures - low vibration | Other | 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. |
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| Measures - high vibration | Other | 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. |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002138 | Calibration |
| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| D008919 | Investigative Techniques |
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