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

NCT01572779 | Completed Phase 2 DMC

• 1 other identifier: ProA-BSM-001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 9

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).

Conditions

Low Back Pain

Keywords

dorsavi; vimove; biofeedback; objective movement data; back pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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.

  over 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

BSM device with bio-feedback

Device: BSM device with bio-feedback

Control

PLACEBO COMPARATOR

The BSM device without feed-back

Device: BSM device with no bio-feedback

Interventions

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).

Also known as: ViMove

Intervention

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.

Also known as: ViMove with no Feedback

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject provides informed consent
• Age between 18 and 65 years of age
• At least moderate intensity low back pain (LBP) and/or back related leg pain, as defined by a QVAS score \> 3 (Carragee, Spine 2000).
• Initial QVAS score of \> 3 out of 10
• 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).

You may not qualify if:

• Lower back surgery within previous twelve (12) months.
• Females who are pregnant.
• Subjects with a severe hearing impairment.
• Evidence of non mechanical contributing cause for lower back pain e.g. neoplasm, infection, fracture, inflammatory disorder.
• Preceding chronic neurological changes (Sub Acute group only).
• Implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator)
• Nerve block, spinal injection or anesthetic procedure for the treatment of lower back pain within 12 months of the study.
• 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.
• 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.
• Known allergic skin reaction to tapes and plasters.
• Subject who is currently enrolled in an investigational drug or device study.

Sponsors & Collaborators

• Pro-Active Medical Pty Ltd: lead
• Department of Business and Innovation, Victoria, Australia: collaborator

Study Sites (9)

Metro Spinal Clinic

Caulfield, Victoria, 3162, Australia

Location

Stanlake Specialist Centre

Footscray, Victoria, 3011, Australia

Location

Myers Street Family Medical

Geelong, Victoria, 3220, Australia

Location

Peak Musculoskeletal

Hampton, Victoria, 3188, Australia

Location

Austin Hopsital

Heidelberg, Victoria, 3084, Australia

Location

Olympic Park Sports Medicine Centre

Melbourne, Victoria, 3003, Australia

Location

Epworth Hospital Richmond

Richmond, Victoria, 3121, Australia

Location

Bounce Health Group

Ringwood, Victoria, 3084, Australia

Location

The Clinic Werribee

Werribee, Victoria, 3030, Australia

Location

Related Publications (1)

• 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.

  PMID: 26022102 DERIVED

Related Links

• device description

MeSH Terms

Conditions

Low Back Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: April 6, 2012
• Study Start: November 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

AU (9)