A Study to Investigate the Effect of a New Postural Bio-feedback Device on Low Back Pain
NCT ID: NCT01572779
Last Updated: 2015-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2009-11-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
BSM device with bio-feedback
BSM device with bio-feedback
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).
Control
The BSM device without feed-back
BSM device with no bio-feedback
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.
Interventions
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BSM device with bio-feedback
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).
BSM device with no bio-feedback
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age between 18 and 65 years of age
3. At least moderate intensity low back pain (LBP) and/or back related leg pain, as defined by a QVAS score \> 3 (Carragee, Spine 2000).
4. Initial QVAS score of \> 3 out of 10
5. 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
2. Females who are pregnant.
3. Subjects with a severe hearing impairment.
4. Evidence of non mechanical contributing cause for lower back pain e.g. neoplasm, infection, fracture, inflammatory disorder.
5. Preceding chronic neurological changes (Sub Acute group only).
6. Implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator)
7. Nerve block, spinal injection or anesthetic procedure for the treatment of lower back pain within 12 months of the study.
8. 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.
9. 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.
10. Known allergic skin reaction to tapes and plasters.
11. Subject who is currently enrolled in an investigational drug or device study.
18 Years
65 Years
ALL
No
Sponsors
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Department of Business and Innovation, Victoria, Australia
UNKNOWN
Pro-Active Medical Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Jensen, MB BS FAFMM
Role: PRINCIPAL_INVESTIGATOR
Stanlake Specialist Centre
Adrian Jury, MD
Role: PRINCIPAL_INVESTIGATOR
Myers Street Family Medical
Joe Garra, MD
Role: PRINCIPAL_INVESTIGATOR
The Clinic Werribee
Peter Braun, MD
Role: PRINCIPAL_INVESTIGATOR
Stanlake Specialist Centre
Robert Laird
Role: PRINCIPAL_INVESTIGATOR
Austin Hospital Pysiotherapy Outpatients
Locations
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Metro Spinal Clinic
Caulfield, Victoria, Australia
Stanlake Specialist Centre
Footscray, Victoria, Australia
Myers Street Family Medical
Geelong, Victoria, Australia
Peak Musculoskeletal
Hampton, Victoria, Australia
Austin Hopsital
Heidelberg, Victoria, Australia
Olympic Park Sports Medicine Centre
Melbourne, Victoria, Australia
Epworth Hospital Richmond
Richmond, Victoria, Australia
Bounce Health Group
Ringwood, Victoria, Australia
The Clinic Werribee
Werribee, Victoria, Australia
Countries
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References
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Kent P, Laird R, Haines T. The effect of changing movement and posture using motion-sensor biofeedback, versus guidelines-based care, on the clinical outcomes of people with sub-acute or chronic low back pain-a multicentre, cluster-randomised, placebo-controlled, pilot trial. BMC Musculoskelet Disord. 2015 May 29;16:131. doi: 10.1186/s12891-015-0591-5.
Related Links
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device description
Other Identifiers
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ProA-BSM-001
Identifier Type: -
Identifier Source: org_study_id
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