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Completed

NCT Number: NCT01572779

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

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Metro Spinal Clinic, Caulfield, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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).

Other names: ViMove

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.

Other names: ViMove with no Feedback

Primary outcomes

  1. Roland Morris Disability Questionaire (RMDQ-23)

    Time frame: over 12 months

    Functional Outcome measure

  2. Patient Specific Functional Scale (PSFS)

    Time frame: over 12 months

    Functional Outcome Measure

  3. Quadruple Visual Analogue Scale (QVAS)

    Time frame: over 12 months

    Pain Scale

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.

    Time frame: over 12 months

    Functional Outcome Measure

Sponsors and collaborators

Lead sponsor

Pro-Active Medical Pty Ltd

Industry

Collaborators

  • Department of Business and Innovation, Victoria, Australia

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Apr 6, 2012
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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