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

Primary Purpose

Low Back Pain

Status

Completed

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

BSM device with bio-feedback

BSM device with no bio-feedback

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring dorsavi, vimove, biofeedback, objective movement data, back pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

BSM device with bio-feedback

The BSM device without feed-back

Outcomes

Primary Outcome Measures

Roland Morris Disability Questionaire (RMDQ-23)

Functional Outcome measure

Patient Specific Functional Scale (PSFS)

Functional Outcome Measure

Quadruple Visual Analogue Scale (QVAS)

Pain Scale

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01572779

First Posted

June 7, 2011

Last Updated

March 23, 2015

Sponsor

Pro-Active Medical Pty Ltd

Collaborators

Department of Business and Innovation, Victoria, Australia

1. Study Identification

Unique Protocol Identification Number

NCT01572779

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pro-Active Medical Pty Ltd

Collaborators

Department of Business and Innovation, Victoria, Australia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

BSM device with bio-feedback

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

The BSM device without feed-back

Intervention Type

Device

Intervention Name(s)

BSM device with bio-feedback

Other Intervention Name(s)

ViMove

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

BSM device with no bio-feedback

Other Intervention Name(s)

ViMove with no Feedback

Intervention Description

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.

Primary Outcome Measure Information:

Title

Roland Morris Disability Questionaire (RMDQ-23)

Description

Functional Outcome measure

Time Frame

over 12 months

Title

Patient Specific Functional Scale (PSFS)

Description

Functional Outcome Measure

Time Frame

over 12 months

Title

Quadruple Visual Analogue Scale (QVAS)

Description

Pain Scale

Time Frame

over 12 months

Secondary Outcome Measure Information:

Title

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.

Description

Functional Outcome Measure

Time Frame

over 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: