Clinical trial NCT01572779: A Study to Investigate the Effect of a New Postural Bio-feedback Device on Low Back Pain
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Keywords: dorsavi
vimove
biofeedback
objective movement data
back pain
Lead sponsor: Pro-Active Medical Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Department of Business and Innovation, Victoria, Australia
First posted: 2012-04-06
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. Subject provides informed consent
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:

1. Lower back surgery within previous twelve (12) months.
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.

Primary outcomes:
measure: Roland Morris Disability Questionaire (RMDQ-23)
timeFrame: over 12 months
measure: Patient Specific Functional Scale (PSFS)
timeFrame: over 12 months
measure: Quadruple Visual Analogue Scale (QVAS)
timeFrame: over 12 months
Secondary outcomes:
measure: 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.
timeFrame: over 12 months
Other outcomes:
Locations:
city: Caulfield
country: Australia
facility: Metro Spinal Clinic
state: Victoria
city: Footscray
country: Australia
facility: Stanlake Specialist Centre
state: Victoria
city: Geelong
country: Australia
facility: Myers Street Family Medical
state: Victoria
city: Hampton
country: Australia
facility: Peak Musculoskeletal
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hopsital
state: Victoria
city: Melbourne
country: Australia
facility: Olympic Park Sports Medicine Centre
state: Victoria
city: Richmond
country: Australia
facility: Epworth Hospital Richmond
state: Victoria
city: Ringwood
country: Australia
facility: Bounce Health Group
state: Victoria
city: Werribee
country: Australia
facility: The Clinic Werribee
state: Victoria
Study officials:
affiliation: Stanlake Specialist Centre
name: Steven Jensen, MB BS FAFMM
role: PRINCIPAL_INVESTIGATOR
affiliation: Myers Street Family Medical
name: Adrian Jury, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Clinic Werribee
name: Joe Garra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanlake Specialist Centre
name: Peter Braun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Austin Hospital Pysiotherapy Outpatients
name: Robert Laird
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.