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| Name | Class |
|---|---|
| Department of Business and Innovation, Victoria, Australia | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | BSM device with bio-feedback |
|
| Control | Placebo Comparator | The BSM device without feed-back |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BSM device with bio-feedback | Device | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Jensen, MB BS FAFMM | Stanlake Specialist Centre | Principal Investigator |
| Adrian Jury, MD | Myers Street Family Medical | Principal Investigator |
| Joe Garra, MD | The Clinic Werribee | Principal Investigator |
| Peter Braun, MD | Stanlake Specialist Centre | Principal Investigator |
| Robert Laird | Austin Hospital Pysiotherapy Outpatients | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metro Spinal Clinic | Caulfield | Victoria | 3162 | Australia | ||
| Stanlake Specialist Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26022102 | Derived | 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. |
| Label | URL |
|---|---|
| device description | View source |
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|
|
| BSM device with no bio-feedback | Device | 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. |
|
|
| Footscray |
| Victoria |
| 3011 |
| Australia |
| Myers Street Family Medical | Geelong | Victoria | 3220 | Australia |
| Peak Musculoskeletal | Hampton | Victoria | 3188 | Australia |
| Austin Hopsital | Heidelberg | Victoria | 3084 | Australia |
| Olympic Park Sports Medicine Centre | Melbourne | Victoria | 3003 | Australia |
| Epworth Hospital Richmond | Richmond | Victoria | 3121 | Australia |
| Bounce Health Group | Ringwood | Victoria | 3084 | Australia |
| The Clinic Werribee | Werribee | Victoria | 3030 | Australia |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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