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Trial registered on ANZCTR


Registration number
ACTRN12609000157279
Ethics application status
Approved
Date submitted
20/03/2009
Date registered
25/03/2009
Date last updated
23/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to investigate the effect of a new postural bio-feedback device on low back pain.
Scientific title
A multi-centre randomised, placebo controlled open-label pilot study of Back Strain Monitor (BSM) with Feedback compared with the BSM without feedback on the effects of pain and function in subjects with moderate lower back pain.
Secondary ID [1] 295442 0
NCT01572779
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 4512 0
Condition category
Condition code
Musculoskeletal 4793 4793 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 datalogger carried in the pocket by the subject (the size of a small mobile phone).
Intervention code [1] 4263 0
Treatment: Devices
Intervention code [2] 4264 0
Rehabilitation
Comparator / control treatment
The 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.
Control group
Placebo

Outcomes
Primary outcome [1] 5653 0
Functional Outcome measure: Roland Morris Disability Questionaire (RMDQ-23) Minimal clinically important change = 30%
Timepoint [1] 5653 0
At baseline, end of week 1 and at weeks 3, 6, 8, 12, 26 and 52.
Primary outcome [2] 5654 0
Functional Outcome Measure: Patient Specific Functional Scale (PSFS). Minimal detectable change is 2 points.
Timepoint [2] 5654 0
At baseline, end of week 1 and at weeks 3, 6, 8, 12, 26 and 52.
Primary outcome [3] 5655 0
Pain Scale: Quadruple Visual Analogue Scale (QVAS) Minimal clinically important change = 20%
Timepoint [3] 5655 0
At baseline, end of week 1 and at weeks 3, 6, 8, 12, 26 and 52.
Secondary outcome [1] 241540 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.
Timepoint [1] 241540 0
Measured at Day 2, 4, 9, 17, 24 and 38 for subjects with sub-acute pain. Measured at Day 2, 4, 9, 17, 24, 38, 52 and 66 for subjects with chronic pain.

Eligibility
Key inclusion criteria
Subjects must meet all of the following criteria to be eligible for the study:
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects who meet any of the following criteria will not be eligible for participation in this study:
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)
No concealment at subject level.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent biostatistician will randomise the sites using simlpe randomisation where a randomisation table is used from a statistic book.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomised trial for early proof of concept study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2009
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
9/08/2012
Date of last data collection
Anticipated
Actual
11/06/2013
Sample size
Target
96
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 1568 0
3030
Recruitment postcode(s) [2] 1569 0
3220

Funding & Sponsors
Funding source category [1] 4699 0
Commercial sector/Industry
Name [1] 4699 0
Pro-Active Medical P/L
Country [1] 4699 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pro-Active Medical P/L
Address
Level 1, 120 Jolimont Road
East Melbourne 3002
Country
Australia
Secondary sponsor category [1] 4244 0
None
Name [1] 4244 0
Address [1] 4244 0
Country [1] 4244 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6734 0
The Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee (RACGP NREEC)
Ethics committee address [1] 6734 0
Ethics committee country [1] 6734 0
Australia
Date submitted for ethics approval [1] 6734 0
12/01/2009
Approval date [1] 6734 0
11/02/2009
Ethics approval number [1] 6734 0
NREEC 08/005

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29423 0
Dr Steven Jensen
Address 29423 0
Stanlake Specialist Centre
5 Stanlake Street,
Footscray, Victoria, 3011
Country 29423 0
Australia
Phone 29423 0
+61-3-9318-5233
Fax 29423 0
Email 29423 0
jensen@tpg.com.au
Contact person for public queries
Name 12670 0
Andrew Ronchi
Address 12670 0
Level 1, 120 Jolimont Road
East Melbourne 3002
Country 12670 0
Australia
Phone 12670 0
+61 3 9652 2192
Fax 12670 0
+61 3 8610 1024
Email 12670 0
ar@dorsavi.com
Contact person for scientific queries
Name 3598 0
Andrew Ronchi
Address 3598 0
Level 1, 120 Jolimont Road
East Melbourne 3002
Country 3598 0
Australia
Phone 3598 0
+61 3 9652 2192
Fax 3598 0
+61 3 8610 1024
Email 3598 0
ar@dorsavi.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.