Back PainVibrioceptionNCT01795443
Lumbar Proprioception in Lower Back Pain Patients Versus Healthy Subjects : a Comparative Study on the Effects of Low- and High-frequency Muscle Vibrations
A study testing Calibration, Practice and Measures - no vibration in people with Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- What is being tested?
- Calibration, Practice and Measures - no vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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)
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Back Pain
- Being tested
- Calibration, Practice, Measures - no vibration, Measures - low vibration, Measures - high vibration
- Keywords
- vibration, proprioception
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalibrationOther
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.
PracticeOther
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.
Measures - no vibrationOther
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.
Measures - low vibrationOther
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.
Measures - high vibrationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration |
| 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; Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration |
| 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; Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration |
| 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; Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration |
| 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; Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration |
| 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; Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration |
| 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; Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration |
| 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; Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration |
| 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; Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration |
| 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; Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration |
| 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; Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration |
| 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; Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement erreur
Measures are made with an electronic goniometer.
Measurement erreur = (Lumbar angle in the target position) - (lumbar angle in patient-perceived target position)
Measured: Baseline (day O)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Dupeyron, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795443
- Sponsor's protocol ID
- LOCAL/2012/AD-03
- Other IDs
- 2012-A01733-40
- Acronym
- Vibrioception
- Status last verified
- Mar 2015
- First submitted
- 18 Feb 2013
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01795443
- Acronym / sponsor ID
- Vibrioception / LOCAL/2012/AD-03
- Conditions
- Back Pain
- Keywords
- vibration, proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers 1 | Active comparator | Other: Calibration, Other: Practice, Other: Measures - no vibration, Other: Measures - low vibration, Other: Measures - high vibrationThe 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 comparator | Other: Calibration, Other: Practice, Other: Measures - no vibration, Other: Measures - low vibration, Other: Measures - high vibrationThe 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 comparator | Other: Calibration, Other: Practice, Other: Measures - no vibration, Other: Measures - low vibration, Other: Measures - high vibrationThe 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 comparator | Other: Calibration, Other: Practice, Other: Measures - no vibration, Other: Measures - low vibration, Other: Measures - high vibrationThe 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 comparator | Other: Calibration, Other: Practice, Other: Measures - no vibration, Other: Measures - low vibration, Other: Measures - high vibrationThe 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 comparator | Other: Calibration, Other: Practice, Other: Measures - no vibration, Other: Measures - low vibration, Other: Measures - high vibrationThe 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 | Experimental | Other: Calibration, Other: Practice, Other: Measures - no vibration, Other: Measures - low vibration, Other: Measures - high vibrationThe 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 | Experimental | Other: Calibration, Other: Practice, Other: Measures - no vibration, Other: Measures - low vibration, Other: Measures - high vibrationThe 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 | Experimental | Other: Calibration, Other: Practice, Other: Measures - no vibration, Other: Measures - low vibration, Other: Measures - high vibrationThe 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 | Experimental | Other: Calibration, Other: Practice, Other: Measures - no vibration, Other: Measures - low vibration, Other: Measures - high vibrationThe 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 | Experimental | Other: Calibration, Other: Practice, Other: Measures - no vibration, Other: Measures - low vibration, Other: Measures - high vibrationThe 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 | Experimental | Other: Calibration, Other: Practice, Other: Measures - no vibration, Other: Measures - low vibration, Other: Measures - high vibrationThe 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; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalibrationSubjects 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. | Other | Back pain patients 1, Back pain patients 2, Back pain patients 3, Back pain patients 4, Back pain patients 5, Back pain patients 6, Healthy volunteers 1, Healthy volunteers 2, Healthy volunteers 3, Healthy volunteers 4, Healthy volunteers 5, Healthy volunteers 6 |
| PracticePropioception 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. | Other | Back pain patients 1, Back pain patients 2, Back pain patients 3, Back pain patients 4, Back pain patients 5, Back pain patients 6, Healthy volunteers 1, Healthy volunteers 2, Healthy volunteers 3, Healthy volunteers 4, Healthy volunteers 5, Healthy volunteers 6 |
| Measures - no vibrationThe 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. | Other | Back pain patients 1, Back pain patients 2, Back pain patients 3, Back pain patients 4, Back pain patients 5, Back pain patients 6, Healthy volunteers 1, Healthy volunteers 2, Healthy volunteers 3, Healthy volunteers 4, Healthy volunteers 5, Healthy volunteers 6 |
| Measures - low vibrationThe 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. | Other | Back pain patients 1, Back pain patients 2, Back pain patients 3, Back pain patients 4, Back pain patients 5, Back pain patients 6, Healthy volunteers 1, Healthy volunteers 2, Healthy volunteers 3, Healthy volunteers 4, Healthy volunteers 5, Healthy volunteers 6 |
| Measures - high vibrationThe 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. | Other | Back pain patients 1, Back pain patients 2, Back pain patients 3, Back pain patients 4, Back pain patients 5, Back pain patients 6, Healthy volunteers 1, Healthy volunteers 2, Healthy volunteers 3, Healthy volunteers 4, Healthy volunteers 5, Healthy volunteers 6 |
Primary outcome
Measurement erreur
Time frame: Baseline (day O)
Measures are made with an electronic goniometer. Measurement erreur = (Lumbar angle in the target position) - (lumbar angle in patient-perceived target position)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Dupeyron, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calibration, Practice and Measures - no vibration in people with Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement erreur (time frame: Baseline (day O)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.