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

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.

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).

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Device: BSM device with bio-feedback; Device: BSM device with no bio-feedback

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Caulfield, Victoria, Australia, 3162
      • Metro Spinal Clinic
    • Footscray, Victoria, Australia, 3011
      • Stanlake Specialist Centre
    • Geelong, Victoria, Australia, 3220
      • Myers Street Family Medical
    • Hampton, Victoria, Australia, 3188
      • Peak Musculoskeletal
    • Heidelberg, Victoria, Australia, 3084
      • Austin Hopsital
    • Melbourne, Victoria, Australia, 3003
      • Olympic Park Sports Medicine Centre
    • Richmond, Victoria, Australia, 3121
      • Epworth Hospital Richmond
    • Ringwood, Victoria, Australia, 3084
      • Bounce Health Group
    • Werribee, Victoria, Australia, 3030
      • The Clinic Werribee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: ViMove with no Feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Pro-Active Medical Pty Ltd
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• device description

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: June 7, 2011
• First Submitted That Met QC Criteria: April 4, 2012
• First Posted (Estimate): April 6, 2012

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: biofeedback; back pain; dorsavi; vimove; objective movement data
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: ProA-BSM-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No