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

Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572779
• Other study ID #: ProA-BSM-001
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2011
• Last updated: March 23, 2015
• Start date: November 2009
• Est. completion date: June 2013

Study information

• Verified date: March 2015
• Source: Pro-Active Medical Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Subject provides informed consent

2. Age between 18 and 65 years of age

3. At least moderate intensity low back pain (LBP) and/or back related leg pain, as defined by a QVAS score > 3 (Carragee, Spine 2000).

4. Initial QVAS score of > 3 out of 10

5. 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:

1. Lower back surgery within previous twelve (12) months.

2. Females who are pregnant.

3. Subjects with a severe hearing impairment.

4. Evidence of non mechanical contributing cause for lower back pain e.g. neoplasm, infection, fracture, inflammatory disorder.

5. Preceding chronic neurological changes (Sub Acute group only).

6. Implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator)

7. Nerve block, spinal injection or anesthetic procedure for the treatment of lower back pain within 12 months of the study.

8. 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.

9. 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.

10. Known allergic skin reaction to tapes and plasters.

11. Subject who is currently enrolled in an investigational drug or device study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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).
• 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.

Locations

Country	Name	City	State
Australia	Metro Spinal Clinic	Caulfield	Victoria
Australia	Stanlake Specialist Centre	Footscray	Victoria
Australia	Myers Street Family Medical	Geelong	Victoria
Australia	Peak Musculoskeletal	Hampton	Victoria
Australia	Austin Hopsital	Heidelberg	Victoria
Australia	Olympic Park Sports Medicine Centre	Melbourne	Victoria
Australia	Epworth Hospital Richmond	Richmond	Victoria
Australia	Bounce Health Group	Ringwood	Victoria
Australia	The Clinic Werribee	Werribee	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Pro-Active Medical Pty Ltd	Department of Business and Innovation, Victoria, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roland Morris Disability Questionaire (RMDQ-23)	Functional Outcome measure	over 12 months	No
Primary	Patient Specific Functional Scale (PSFS)	Functional Outcome Measure	over 12 months	No
Primary	Quadruple Visual Analogue Scale (QVAS)	Pain Scale	over 12 months	No
Secondary	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	over 12 months	No

External Links

•   device description