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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, Gard, 30029

Other trials in France

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 groups in NCT01795443
Study groupRoleWhat they receive
Healthy volunteers 1Active 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;
Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration
Healthy volunteers 2Active 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;
Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration
Healthy volunteers 3Active 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;
Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration
Healthy volunteers 4Active 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;
Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration
Healthy volunteers 5Active 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;
Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration
Healthy volunteers 6Active 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;
Receives: Other: Calibration; Other: Practice; Other: Measures - no vibration; Other: Measures - low vibration; Other: Measures - high vibration
Back pain patients 1ExperimentalThe 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 2ExperimentalThe 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 3ExperimentalThe 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 4ExperimentalThe 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 5ExperimentalThe 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 6ExperimentalThe 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.

  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)

    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.

  1. First posted20 Feb 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

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)
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

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.

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