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

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

Interventions

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).

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.

Sponsors & Collaborators

• Department of Business and Innovation, Victoria, Australia

  collaborator UNKNOWN

• Pro-Active Medical Pty Ltd

  lead INDUSTRY

Principal Investigators

• Steven Jensen, MB BS FAFMM · Stanlake Specialist Centre

• Adrian Jury, MD · Myers Street Family Medical

• Joe Garra, MD · The Clinic Werribee

• Peter Braun, MD · Stanlake Specialist Centre

• Robert Laird · Austin Hospital Pysiotherapy Outpatients

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2013-06-30

Completion

2013-06-30

Countries

• Australia

Study Locations