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Trial registered on ANZCTR


Registration number
ACTRN12616001722482
Ethics application status
Approved
Date submitted
12/12/2016
Date registered
15/12/2016
Date last updated
20/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigator initiated validation study comparing ViMove with standardized outcome measures of function and disability.
Scientific title
An investigator initiated validation study comparing ViMove with standardized outcome measures of function and disability in adults with chronic low back pain.
Secondary ID [1] 290730 0
None
Universal Trial Number (UTN)
U1111-1190-8481
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain (with or without leg pain) for > 3 months 301307 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301061 301061 0 0
Other physical medicine / rehabilitation
Musculoskeletal 301075 301075 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Subjective and objective measures of low back pain and movement will be utilised in patients with chronic low back pain.

2 ViMove sensors are placed on the patient's back by the treating physiotherapist. Physio's will receive a training session (at an early time) to ensure proper sensor placement and adherence to protocols. 1 sensor is in-line with the posterior superior iliac spine, and the other is on the thoracic spine. Both are placed according to a protocol+guide.

Initial assessment session: Whilst wearing ViMove sensors in clinic, patients will perform a set of back extension, flexion, and lateral flexion movements. This set will be repeated 5 times. This assessment is referred to as a ViMove live low back assessment and takes approximately 10-15 minutes total. Participants do not need to do anything with the sensors, as they are attached using disposable adhesives. Participants will also be asked to complete a questionnaire package which contains all subjective measures.
Once the in-clinic assessments and questionnaires are completed, participants will leave the clinic whilst still wearing the sensors and will go about their day. Sensors will monitor the participants low back movements, in what is referred to as ViMove low back monitoring. Sensors will be worn for approximately 6-10 hours outside of the clinic.

Sensors can be returned directly to the clinic, or can be mailed back, This will be outlined to the participant

This same procedure (live assessment, questionnaires, monitoring) will be repeated at a follow-up date 8 weeks later.

Patients will not receive any interventions as part of this trial, and will be treated according to the management plan of their treating physician.
Intervention code [1] 296631 0
Not applicable
Comparator / control treatment
Comparison of ViMove data with standard measures of pain and disability.
These are:
Owestry Disability Index,
Roland Morris Disability Questionnaire,
Fear-Avoidance Beliefs Questionnaire (FABQ),
Depression Anxiety Stress Scale (DASS),
and the Pain Self-Efficacy Questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 300481 0
Movement data from ViMove sensors:
- maximum range of movement during lumbar flexion, extension, and lateral flexion
Timepoint [1] 300481 0
The timepoints for this will occur at the end of each of the two assessment days.
These two days were referred to as "Initial Assessment" and "follow-up", and occur 8 weeks apart.
Primary outcome [2] 300482 0
Lumbar maximum flexion range of movement as a proportion of trunk flexion movement (%Lumbar/Trunk).
This is automatically assessed using Vimove sensors and accompanying propriertary software. Output will be viewable on the computer/tablet that is used during the assessment.
Timepoint [2] 300482 0
The timepoints for this will occur at the end of each of the two assessment days.
These two days were referred to as "Initial Assessment" and "follow-up", and occur 8 weeks apart.
Primary outcome [3] 300483 0
Activity limitation measured with the Oswestry Disability Index
Timepoint [3] 300483 0
The timepoints for this will occur at the end of each of the two assessment days.
These two days were referred to as "Initial Assessment" and "follow-up", and occur 8 weeks apart.
Secondary outcome [1] 330071 0
Correlation of the Oswestry Disability Index (ODI) with the ViMove %Lumbar/Trunk ratio.
Timepoint [1] 330071 0
The timepoints for this will occur at the end of each of the two assessment days.
These two days were referred to as "Initial Assessment" and "follow-up", and occur 8 weeks apart.
Secondary outcome [2] 330147 0
Correlation between the Roland Morris Disability Questionnaire (RMDQ) with the ViMove %Lumbar/Trunk ratio.
Timepoint [2] 330147 0
The timepoints for this will occur at the end of each of the two assessment days.
These two days were referred to as "Initial Assessment" and "follow-up", and occur 8 weeks apart.
Secondary outcome [3] 330148 0
Correlation between Fear-Avoidance Beliefs Questionnaire (FABQ) and the ViMove %Lumbar/Trunk ratio.
Timepoint [3] 330148 0
The timepoints for this will occur at the end of each of the two assessment days.
These two days were referred to as "Initial Assessment" and "follow-up", and occur 8 weeks apart.
Secondary outcome [4] 330149 0
Correlation between the Depression Anxiety Stress Scale (DASS) and the ViMove %Lumbar/Trunk ratio.
Timepoint [4] 330149 0
The timepoints for this will occur at the end of each of the two assessment days.
These two days were referred to as "Initial Assessment" and "follow-up", and occur 8 weeks apart.
Secondary outcome [5] 330150 0
Correlation between the Pain Self-Efficacy Questionnaire (PSEQ) and the ViMove %Lumbar/Trunk ratio.
Timepoint [5] 330150 0
The timepoints for this will occur at the end of each of the two assessment days.
These two days were referred to as "Initial Assessment" and "follow-up", and occur 8 weeks apart.

Eligibility
Key inclusion criteria
1. Adults aged over 18 and < 65
2. Low Back pain for > 3 months
3. Pain score (as measured by a Numeric Rating Scale [NRS]) at baseline = or > 3
4. Able to provide informed consent
5. Does not meet any of the exclusion criteria
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acute back pain (< 3 months)
2. Performance of assessment protocol is contraindicated for the participant
3. Illness or injury other than lower back pain that impacts upon function or causes disability or an inability to move independently.
4. Is pregnant or planning to become pregnant during the course of the study
5. Participants with a severe hearing impairment or inability to follow verbal instructions.
6. Significant medical or psychological abnormalities/conditions, a history of substance abuse or recent history of a medical-surgical intervention that in the opinion of the investigator would interfere either with the ability to complete the study or the assessments.
7. Known allergy skin reaction to tapes and plasters.
8. Participant who is currently enrolled in an investigational drug or device study
9. Inability to comply with study requirements or complete questionnaires in English independently.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
N=40. As this is a pilot study to gather information to be used in a follow-up randomized study, no formal sample size calculations were undertaken. Up to 50 participants are predicted to be enrolled initially if we assume a 25% drop out between baseline and follow-up.

An initial descriptive analysis will be completed on baseline measures of movement to ascertain mean scores, ranges and standard deviations in this population.
Correlation analysis will be completed using a Pearson’s correlation coefficient to determine if there is a relationship between ViMove data and other outcomes collected at baseline and follow-up.
Other collected data will be used in the discussion of these primary results, as they would be in current treatment and decision making.
All findings will be deemed significant with a p value of <0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/03/2017
Actual
30/03/2017
Date of last participant enrolment
Anticipated
Actual
18/10/2017
Date of last data collection
Anticipated
Actual
13/12/2017
Sample size
Target
40
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 14867 0
3101 - Kew
Recruitment postcode(s) [2] 14868 0
3131 - Forest Hill
Recruitment postcode(s) [3] 18375 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 295161 0
Commercial sector/Industry
Name [1] 295161 0
Precison Brain, Spine and Pain Centre
Country [1] 295161 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Precision Brain, Spine and Pain Centre
Address
115 Cotham Road, Kew, Victoria 3101
Country
Australia
Secondary sponsor category [1] 293985 0
None
Name [1] 293985 0
Address [1] 293985 0
Country [1] 293985 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296511 0
Bellberry Limited
Ethics committee address [1] 296511 0
129 Glen Osmond Rd, Eastwood. South Australia. 5063
Ethics committee country [1] 296511 0
Australia
Date submitted for ethics approval [1] 296511 0
15/12/2016
Approval date [1] 296511 0
11/01/2017
Ethics approval number [1] 296511 0

Summary
Brief summary
The recent availability of low cost wearable sensors provides the research community with a rich opportunity to expand knowledge about the movement and activity of both healthy people and those suffering from a range of chronic conditions. This area is of particular interest in the management of so-called lifestyle diseases where activity is encouraged as a key component of both prevention and treatment.

This study is designed to further the understanding of specific physical movements and activity in people with non-specific low back pain. The study will assess 40 people with low back pain on 2 separate occasions to measure a range of bio-psycho-social factors that are typically impacted by this condition. The study will develop our understanding of the relationship between these factors, specifically comparing commonly-used (but subjective) outcome measures to the objective outcomes provided by portable sensors.
Trial website
Trial related presentations / publications
Public notes
Recruitment Sites are:
- Precision Brain, Spine and Pain Centre, Cotham Rd, Kew, Victoria, 3101
- Superspine, 380 Springvale Rd, Forest Hill, Victoria, 3131
- LifeCare Physiotherapy Frankston, 342 Nepean Highway, Frankston, Victoria. 3199

Contacts
Principal investigator
Name 71102 0
Dr Richard Sullivan
Address 71102 0
Precision Brain, Spine & Pain Centre
115 Cotham Road, Kew, Victoria 3101
Country 71102 0
Australia
Phone 71102 0
+ 61 3 8862 0000
Fax 71102 0
Email 71102 0
[email protected]
Contact person for public queries
Name 71103 0
Sangeeth Wanasinghage
Address 71103 0
dorsaVi
1/112-120 Jolimont Rd, East Melbourne, Victoria, 3002
Country 71103 0
Australia
Phone 71103 0
+61 422 106 668
Fax 71103 0
Email 71103 0
[email protected]
Contact person for scientific queries
Name 71104 0
Richard Sullivan
Address 71104 0
Precision Brain, Spine & Pain Centre
115 Cotham Road, Kew, Victoria 3101
Country 71104 0
Australia
Phone 71104 0
+61 3 8862 0000
Fax 71104 0
Email 71104 0
[email protected]

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

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