A Study to Investigate the Effect of a New Postural Bio-feedback Device on Low Back Pain

Study Overview
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Brief Summary
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A postural bio-feedback device worn by subjects for 4-10 hours a day for 6 days spread across 6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the chronic group. The device records movement and muscle activity data relating to the lower back. Bio-feedback is delivered to the subject as an audible tone, visual cue or vibration and aims to prompt the subject to alter their posture or position in line with recommendations given by the treating practitioner. Four small sensors are adhered to the lower back and send data wirelessly to a data logger carried in the pocket by the subject (the size of a small mobile phone).

Official Title
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A Multicentre, Cluster Randomised, Placebo-controlled, Open-label Pilot Study of Back Strain Monitor (BSM) With Feedback Compared With the BSM Without Feedback in Subjects With Moderate Lower Back Pain.

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: BSM device with bio-feedback
* Device: BSM device with no bio-feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject provides informed consent Age between 18 and 65 years of age At least moderate intensity low back pain (LBP) and/or back related leg pain, as defined by a QVAS score > 3 (Carragee, Spine 2000). Initial QVAS score of > 3 out of 10 Subjects must be assessed by the practitioner as Sub Acute (3 to 12 weeks post onset of low back pain (LBP) or Chronic (> 12 weeks post onset of low back pain (LBP). Exclusion Criteria: Lower back surgery within previous twelve (12) months. Females who are pregnant. Subjects with a severe hearing impairment. Evidence of non mechanical contributing cause for lower back pain e.g. neoplasm, infection, fracture, inflammatory disorder. Preceding chronic neurological changes (Sub Acute group only). Implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) Nerve block, spinal injection or anesthetic procedure for the treatment of lower back pain within 12 months of the study. Significant medical abnormalities or conditions that in the opinion of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigational device's safety and efficacy. Recent history of a significant medical-surgical intervention that in the judgment of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigative device's safety and efficacy. Known allergic skin reaction to tapes and plasters. Subject who is currently enrolled in an investigational drug or device study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>BSM device with bio-feedback | Device: BSM device with bio-feedback<br>* A postural bio-feedback device worn by subjects for 4-10hours a day for 6 days spread across 6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the chronic group. The device records movement and muscle activity data relating to the lower back. Bio-feedback is delivered to the subject as an audible tone, visual cue or vibration and aims to prompt the subject to alter their posture or position in line with recommendations given by the treating practitioner. Four small sensors are adhered to the lower back and send data wirelessly to a data logger carried in the pocket by the subject (the size of a small mobile phone).<br>* Other names: ViMove;|
| Placebo Comparator: Control<br>The BSM device without feed-back | Device: BSM device with no bio-feedback<br>* The BSM device is worn as a placebo with no bio-feedback given to the subject. The subjects in the control group wear the device for 4-10 hours a day for 6 days spread across 6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the chronic group.<br>* Other names: ViMove with no Feedback;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland Morris Disability Questionaire (RMDQ-23) | Functional Outcome measure | over 12 months | 
| Patient Specific Functional Scale (PSFS) | Functional Outcome Measure | over 12 months | 
| Quadruple Visual Analogue Scale (QVAS) | Pain Scale | over 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change over time from baseline in the range of movement, recorded by the device. Measured in degrees of movement in the three anatomical planes. | Functional Outcome Measure | over 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dorsavi, vimove, biofeedback, objective movement data, back pain