A Study to Investigate the Effect of a New Postural Bio-feedback Device on Low Back Pain
- Conditions
- Low Back Pain
- Interventions
- Device: BSM device with no bio-feedbackDevice: BSM device with bio-feedback
- Registration Number
- NCT01572779
- Lead Sponsor
- Pro-Active Medical Pty Ltd
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control BSM device with no bio-feedback The BSM device without feed-back Intervention BSM device with bio-feedback BSM device with bio-feedback
- Primary Outcome Measures
Name Time Method Quadruple Visual Analogue Scale (QVAS) over 12 months Pain Scale
Roland Morris Disability Questionaire (RMDQ-23) over 12 months Functional Outcome measure
Patient Specific Functional Scale (PSFS) over 12 months Functional Outcome Measure
- Secondary Outcome Measures
Name Time Method 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. over 12 months Functional Outcome Measure
Trial Locations
- Locations (9)
The Clinic Werribee
🇦🇺Werribee, Victoria, Australia
Stanlake Specialist Centre
🇦🇺Footscray, Victoria, Australia
Metro Spinal Clinic
🇦🇺Caulfield, Victoria, Australia
Austin Hopsital
🇦🇺Heidelberg, Victoria, Australia
Peak Musculoskeletal
🇦🇺Hampton, Victoria, Australia
Myers Street Family Medical
🇦🇺Geelong, Victoria, Australia
Epworth Hospital Richmond
🇦🇺Richmond, Victoria, Australia
Olympic Park Sports Medicine Centre
🇦🇺Melbourne, Victoria, Australia
Bounce Health Group
🇦🇺Ringwood, Victoria, Australia