Low Back PainPhase 2NCT01572779

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

A Phase 2 study testing BSM device with bio-feedback and BSM device with no bio-feedback in people with Low Back Pain, run by Pro-Active Medical Pty Ltd at 9 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Low Back Pain
What is being tested?: BSM device with bio-feedback and BSM device with no bio-feedback
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 112 participants
Where: 9 sitesAustralia
Study dates: Nov 2009to Jun 2013
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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)

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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.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Australia9 sites

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

Other trials in Australia

About this study

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.

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
Being tested: BSM device with bio-feedback, BSM device with no bio-feedback
Keywords: dorsavi, vimove, biofeedback, objective movement data, back pain
Medical subject headings: Low Back Pain, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BSM device with bio-feedbackDevice
Also called ViMove
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).
BSM device with no bio-feedbackDevice
Also called ViMove with no 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.

Study groups in NCT01572779
Study group	Role	What they receive
Intervention	Experimental	BSM device with bio-feedback Receives: Device: BSM device with bio-feedback
Control	Placebo comparator	The BSM device without feed-back Receives: Device: BSM device with no bio-feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

Roland Morris Disability Questionaire (RMDQ-23)
Functional Outcome measure
Measured: over 12 months
Patient Specific Functional Scale (PSFS)
Functional Outcome Measure
Measured: over 12 months
Quadruple Visual Analogue Scale (QVAS)
Pain Scale
Measured: 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.
Functional Outcome Measure
Measured: over 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Jun 2013

First posted6 Apr 2012 (estimated)
Study startNov 2009
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01572779
Sponsor's protocol ID: ProA-BSM-001
Status last verified: Mar 2015
First submitted: 7 Jun 2011
Last updated: 25 Mar 2015
Results posted: No
Data monitoring committee: Yes

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.
PubMed 26022102

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01572779
Acronym / sponsor ID: ProA-BSM-001
Conditions: Low Back Pain
Keywords: dorsavi, vimove, biofeedback, objective movement data, back pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: Pro-Active Medical Pty LtdIndustry (pharma, biotech, devices)
Collaborators: Department of Business and Innovation, Victoria, Australia
Study start: Nov 2009
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 6 Apr 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Device: BSM device with bio-feedbackBSM device with bio-feedback
Control	Placebo comparator	Device: BSM device with no bio-feedbackThe BSM device without feed-back

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (11 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BSM device with bio-feedbackAlso: ViMoveA 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	Intervention
BSM device with no bio-feedbackAlso: ViMove with no FeedbackThe 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.	Device	Control

Primary outcome

Roland Morris Disability Questionaire (RMDQ-23)
Time frame: over 12 months
Functional Outcome measure
Patient Specific Functional Scale (PSFS)
Time frame: over 12 months
Functional Outcome Measure
Quadruple Visual Analogue Scale (QVAS)
Time frame: over 12 months
Pain Scale

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
Derived from this study: PubMed 26022102Kent 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.
device descriptionLink provided by the sponsor.

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
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Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven Jensen, MB BS FAFMM principal investigator

Stanlake Specialist Centre

Adrian Jury, MD principal investigator

Myers Street Family Medical

Joe Garra, MD principal investigator

The Clinic Werribee

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BSM device with bio-feedback and BSM device with no bio-feedback in people with Low Back Pain, run by Pro-Active Medical Pty Ltd at 9 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Roland Morris Disability Questionaire (RMDQ-23) (time frame: over 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01572779, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.