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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01572779




Registration number
NCT01572779
Ethics application status
Date submitted
7/06/2011
Date registered
6/04/2012
Date last updated
25/03/2015

Titles & IDs
Public title
A Study to Investigate the Effect of a New Postural Bio-feedback Device on Low Back Pain
Scientific 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.
Secondary ID [1] 0 0
ProA-BSM-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - BSM device with bio-feedback
Treatment: Devices - BSM device with no bio-feedback

Experimental: Intervention - BSM device with bio-feedback

Placebo Comparator: Control - The BSM device without feed-back


Treatment: Devices: 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).

Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Roland Morris Disability Questionaire (RMDQ-23) - Functional Outcome measure
Timepoint [1] 0 0
over 12 months
Primary outcome [2] 0 0
Patient Specific Functional Scale (PSFS) - Functional Outcome Measure
Timepoint [2] 0 0
over 12 months
Primary outcome [3] 0 0
Quadruple Visual Analogue Scale (QVAS) - Pain Scale
Timepoint [3] 0 0
over 12 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
over 12 months

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Metro Spinal Clinic - Caulfield
Recruitment hospital [2] 0 0
Stanlake Specialist Centre - Footscray
Recruitment hospital [3] 0 0
Myers Street Family Medical - Geelong
Recruitment hospital [4] 0 0
Peak Musculoskeletal - Hampton
Recruitment hospital [5] 0 0
Austin Hopsital - Heidelberg
Recruitment hospital [6] 0 0
Olympic Park Sports Medicine Centre - Melbourne
Recruitment hospital [7] 0 0
Epworth Hospital Richmond - Richmond
Recruitment hospital [8] 0 0
Bounce Health Group - Ringwood
Recruitment hospital [9] 0 0
The Clinic Werribee - Werribee
Recruitment postcode(s) [1] 0 0
3162 - Caulfield
Recruitment postcode(s) [2] 0 0
3011 - Footscray
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
3188 - Hampton
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3003 - Melbourne
Recruitment postcode(s) [7] 0 0
3121 - Richmond
Recruitment postcode(s) [8] 0 0
3084 - Ringwood
Recruitment postcode(s) [9] 0 0
3030 - Werribee

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pro-Active Medical Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Department of Business and Innovation, Victoria, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT01572779
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Steven Jensen, MB BS FAFMM
Address 0 0
Stanlake Specialist Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications