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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Department of Business and Innovation, Victoria, Australia
Information provided by (Responsible Party):
Pro-Active Medical Pty Ltd
ClinicalTrials.gov Identifier:
NCT01572779
First received: June 7, 2011
Last updated: May 26, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention Phase
Low Back Pain
Device: BSM device with bio-feedback
Device: BSM device with no bio-feedback
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pro-Active Medical Pty Ltd:

Primary Outcome Measures:
  • Roland Morris Disability Questionaire (RMDQ-23) [ Time Frame: over 12 months ] [ Designated as safety issue: No ]
    Functional Outcome measure

  • Patient Specific Functional Scale (PSFS) [ Time Frame: over 12 months ] [ Designated as safety issue: No ]
    Functional Outcome Measure

  • Quadruple Visual Analogue Scale (QVAS) [ Time Frame: over 12 months ] [ Designated as safety issue: No ]
    Pain Scale


Secondary Outcome Measures:
  • 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. [ Time Frame: over 12 months ] [ Designated as safety issue: No ]
    Functional Outcome Measure


Estimated Enrollment: 96
Study Start Date: November 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
BSM device with bio-feedback
Device: 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).
Other Name: ViMove
Placebo Comparator: Control
The BSM device without feed-back
Device: 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 Name: ViMove with no Feedback

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572779

Locations
Australia, Victoria
Metro Spinal Clinic
Caulfield, Victoria, Australia, 3162
Stanlake Specialist Centre
Footscray, Victoria, Australia, 3011
Myers Street Family Medical
Geelong, Victoria, Australia, 3220
Peak Musculoskeletal
Hampton, Victoria, Australia, 3188
Austin Hopsital
Heidelberg, Victoria, Australia, 3084
Olympic Park Sports Medicine Centre
Melbourne, Victoria, Australia, 3003
Epworth Hospital Richmond
Richmond, Victoria, Australia, 3121
Bounce Health Group
Ringwood, Victoria, Australia, 3084
The Clinic Werribee
Werribee, Victoria, Australia, 3030
Sponsors and Collaborators
Pro-Active Medical Pty Ltd
Department of Business and Innovation, Victoria, Australia
Investigators
Principal Investigator: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Pro-Active Medical Pty Ltd
ClinicalTrials.gov Identifier: NCT01572779     History of Changes
Other Study ID Numbers: ProA-BSM-001
Study First Received: June 7, 2011
Last Updated: May 26, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Pro-Active Medical Pty Ltd:
dorsavi
vimove
biofeedback
objective movement data
back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014