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Trial registered on ANZCTR


Registration number
ACTRN12618001396213
Ethics application status
Approved
Date submitted
8/07/2018
Date registered
20/08/2018
Date last updated
9/04/2019
Date data sharing statement initially provided
9/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
RESTORE - Individualised movement rehabilitation and movement sensor biofeedback for chronic, disabling low back pain
Scientific title
RESTORE - The effect of individualised movement rehabilitation and movement sensor biofeedback on pain-related physical activity limitation and quality-adjusted life years in people with chronic, disabling low back pain
Secondary ID [1] 295457 0
NHMRC APP1145271
Universal Trial Number (UTN)
U1111-1215-7550
Trial acronym
RESTORE (Individualised movement rehabilitation and movement sensor biofeedback for chronic, disabling low back pain)
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Lower back pain 308710 0
Condition category
Condition code
Musculoskeletal 307650 307650 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Cognitive Functional Therapy alone
CFT is a physiotherapist-led individualised behavioural intervention for people with disabling musculoskeletal pain. Based on screening questionnaires and an extensive examination (interview and physical examination), the following unhelpful responses to pain are identified and targeted: cognitive (i.e. negative beliefs), emotional (i.e. pain related fear and distress) and behavioural (i.e. protective muscle guarding, movement, activity avoidance and poor sleep habits) responses. This targeting includes: 1. personalised biopsychosocial pain education; 2. graduated exposure to previously avoided and/or provocative movements and activities with pain control in order to re-engage people with valued activities; and 3. lifestyle change targeting physical activity, sleep habits, stress management.

Arm 2: CFT plus movement sensor biofeedback
Movement sensors enable clinicians to precisely measure movement patterns, postures, back muscle activity and their relationship to pain, both in the clinical setting and during patients’ normal activities of work, rest and play. Via biofeedback, movement sensors can help patients develop an awareness of how they move and the postures they use during activities of daily living, where changes to habituated movement are most important. In this study we will use the ViMove2 clinical movement sensor system (dorsaVi P/L, Melbourne, Australia)

Both CFT treatment groups (arm 1 and arm 2) will have the same treatment frequency of up to 7 treatment sessions over 12 weeks plus a ‘booster’ session at 6 months (initial consultation 60 minutes, otherwise 30-40 minutes). In these treatment groups only, the movement sensors will be placed on the lower back region, with kinematic sensors at the thoracolumbar junction and upper sacrum, and EMG sensors paraspinally at approximately L3. Clinicians will use the ViMove2 app (Apple app store) to access the data using a version that has been modified for this study. The sensors will be worn during each treatment session and for the rest of that day. Patients in the CFT plus movement sensor biofeedback will use a modified version of the myViMove app (Apple app store) to receive biofeedback, which is so intuitive it requires little instruction.

At each treatment session, adherence to the program will be assessed by the physiotherapist and barriers to program adherence will be discussed in a collaborative manner. Participants will self-rate program adherence at 2, 6 and 12 weeks using a 0-10 scale specifically created for this study.

Physiotherapist intervention training
These treatment approaches will be delivered by specially trained physiotherapists in private physiotherapy clinics in Perth and Sydney. That treating physiotherapist training, to the point of competency, will consist of up to 100 hours of workshop participation and direct clinical mentoring, supported by a treatment manual, videos, an e-book and private Facebook discussion groups. The treatment and eBook manual are unpublished training materials specifically designed for the physiotherapists delivering the active interventions.
Intervention code [1] 301768 0
Rehabilitation
Comparator / control treatment
Usual care - This treatment will be whatever care pathway the participant’s health providers recommend and the participant chooses to follow.
Control group
Active

Outcomes
Primary outcome [1] 306638 0
The primary clinical outcome will be pain-related physical activity limitation measured using the Roland Morris Disability Questionnaire.
Timepoint [1] 306638 0
Baseline, 3, 6, 12 (primary timepoint), 26, 40 and 52 week follow-ups.
Primary outcome [2] 306639 0
For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years calculated using the EuroQOL EQ-5D-5L. Economic outcomes will be measured, including direct health costs attributable to consumption of health care resources (measured using extracts from Medicare and Pharmaceutical Benefit databases and direct patient report) and productivity costs (measured using the iMTA Productivity Cost Questionnaire) at 12, 26, 40 and 52 weeks.
Timepoint [2] 306639 0
Baseline, 12, 26, 40 and 52 (primary timepoint) week follow-ups
Secondary outcome [1] 349094 0
Pain intensity (Numeric Pain Rating Scales).
Timepoint [1] 349094 0
Baseline, 12, 26, 40 and 52 weeks follow-ups as secondary outcome. Also at 3 and 6 weeks to facilitate mediation analyses.
Secondary outcome [2] 349095 0
Patient-specific activity limitation (Patient Specific Functional Scale).
Timepoint [2] 349095 0
Baseline, 12, 26, 40 and 52 weeks follow-ups as secondary outcome. Also at 3 and 6 weeks to facilitate mediation analyses.
Secondary outcome [3] 349096 0
Pain catastrophisation (the Pain Catastrophizing Scale).
Timepoint [3] 349096 0
Baseline, 12, 26, 40 and 52 weeks follow-ups as secondary outcome. Also at 3 and 6 weeks to facilitate mediation analyses.
Secondary outcome [4] 349097 0
Pain self-efficacy (the Pain Self-efficacy Questionnaire)
Timepoint [4] 349097 0
Baseline, 12, 26, 40 and 52 weeks follow-ups as secondary outcome. Also at 3 and 6 weeks to facilitate mediation analyses.
Secondary outcome [5] 349098 0
Fear of movement (the physical activity subscale of the Fear Avoidance Beliefs Questionnaire).
Timepoint [5] 349098 0
Baseline, 12, 26, 40 and 52 weeks follow-ups.
Secondary outcome [6] 349104 0
Patient-perceived global improvement (the Patient Global Impression of Change question, 7-point Likert scale)
Timepoint [6] 349104 0
12, 26, 40 and 52 weeks
Secondary outcome [7] 349105 0
Patient satisfaction with care and treatment (a study specific question, 7-point Likert scale)
Timepoint [7] 349105 0
12 weeks.
Secondary outcome [8] 349106 0
Adverse events (defined as any morbidity or events causing unwarranted distress to a participant that were potentially related to any trial-related intervention). These will patient-reported at every clinical and questionnaire contact. The most likely adverse event is an infrequent skin reaction to the sensor adhesive.
Timepoint [8] 349106 0
3, 6, 12, 26, 40 and 52 weeks follow-up questionnaires and at every clinical encounter.
Secondary outcome [9] 349108 0
A composite of lumbosacral movement and paraspinal muscle activity will be measured in both the Cognitive Functional Therapy treatment groups using wearable wireless sensors (DorsaVi P/L) and used in the mediation analysis.
Timepoint [9] 349108 0
Measured at every clinical encounter during the up to 12 week treatment period and at the 6 months follow-up.
Secondary outcome [10] 349109 0
Therapeutic alliance will be measured using the Working Alliance/Theory of Change Inventory in the Cognitive Functional Therapy groups and used in a mediation analysis.
Timepoint [10] 349109 0
3 weeks.

Eligibility
Key inclusion criteria
Participants need to meet all of the following:
1. Adult people with current low back pain that has an episode duration of more than 3 months.
2. Presented to a primary care clinician at least 6 weeks prior for this episode of low back pain.
3. Average low back pain intensity of 4 or more when rated on a 0-10 Numerical Pain Rating Scale.
4. At least moderate pain-related interference with normal work or daily activities (measured by item 8 of the Short Form 36 questionnaire).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If a person has any of the following:
(1) Any medical conditions that prevents them from being physically active (as prescribed by their doctor).
(2) A serious spinal pathology (e.g. fracture, infection, cancer).
(3) Is currently pregnant or has given birth within 3 months.
(4) Inadequate English for the study’s questionnaires and instructions.
(5) A skin allergy to hypoallergenic band-aide or tape adhesives.

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)
Allocation will involve contacting the holder of the allocation schedule who will be at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculation
The sample size was calculated for the primary outcome using the program STATA. A total of 492 patients (164 per group) will be recruited to detect a difference of 2 points (0-24 scale) on the Roland Morris Disability Questionnaire between the CFT-alone group and CFT-plus-movement-sensor group at 52 weeks, p<0.05, 80% power, a common standard deviation of 6 points and a worst-case scenario of 20% drop-out rate. Based on our pilot study results, we hypothesise that the CFT-plus-movement-sensor group would have an average score of 7.5 points on the RMDQ at 52 weeks and the Usual-care group would have a score of 11.5 points. Pragmatically and arbitrarily, we assume the CFT-only group will have a mean outcome that is half-way (9.5) between the other two groups and so we will power the trial to detect this as the smallest likely between-group difference (11.5-9.5=2.0).

Statistical analysis - Treatment efficacy analysis
Repeated-measure linear mixed models will be used to assess the effect of treatment on pain-related disability across all time points (weeks 6, 12, 26, 42 and 52), with the primary comparison being a formal test of adjusted mean differences between groups at 12 weeks. Intention-to-treat principles will be used. Appropriate sensitivity analyses will be performed on multiple imputed datasets.

Estimates of treatment effect will be adjusted for baseline scores of symptom duration, pain intensity, activity limitation and significant clinician cluster effects.

The secondary outcome measures will be evaluated using the equivalent repeated-measure linear mixed models.


Statistical analysis - Cost-effectiveness analysis
All direct health and indirect (productivity) costs incurred by participants will be measured over the 12-month follow-up period. Direct health costs will be collected using MBS and PBS database extractions, and patient questionnaires to capture other health care costs (eg. hospitalisations). Indirect health costs (e.g. travel to appointments) and productivity costs (including absenteeism and presenteeism) will also be captured in these 3 monthly patient questionnaires. Productivity costs will be measured using the ‘iMTA Productivity Cost Questionnaire’.
STaRT MSK Tool scores will be used to test whether, for high risk participants, the treatment effect was greater in the CFT groups than in the usual care group.

Productivity costs measured at specific time points will be extrapolated to the full one-year period using an area under the curve approach. All costs will be calculated using a 2019-2020 financial base year. Hospital costs will be valued using the National Weighted Activity Unit calculators for the 2019-2020 year. Health-related quality of life will be measured baseline and at each follow-up time point using the EQ-5D-5L health utility index and converted to an estimate of quality-adjusted life years gained using the area under the curve approach.

An incremental cost-utility analysis will calculate the difference in costs between intervention and control groups divided by the difference in quality-adjusted life years. Incremental cost-utility analyses will be undertaken from societal (primary analysis) and health service perspectives (secondary analysis). There will also be analyses undertaken for valuation of productivity costs using human capital (primary analysis) and friction methods (secondary analysis). Bootstrap resampling (2000 replications of original sample size) will be used to generate a 95% confidence ellipse surrounding the incremental cost-utility estimate. Cost-effectiveness acceptability curve analyses will be undertaken if the intervention is not found to dominate the control condition.


Moderation analysis
To investigate potential moderators of treatment including cognitive flexibility, baseline disability, baseline pain, catastrophisation and self-efficacy, longitudinal multi-level linear regression models will include the independent variables of baseline potential moderators, treatment groups, plus interaction terms between the potential moderator and the treatment groups, with the outcome of either pain-related activity limitation or pain intensity being the dependent variable.


Mediation analysis
To investigate whether improvement in patients’ disability was mediated by correction of habituated movement impairments, changing patient’s pain-related cognitions and emotions, a multilevel structural equation model framework will be utilised. Investigation of the mediation roles of cognitions and emotions will occur using data from all patients; whereas, investigation of the mediation roles of change in movement will occur using data from only patients in the CFT groups. Results will be expressed as standardised estimates of mediated treatment effect with bootstrapped 95% confidence intervals.

Recruitment
Recruitment status
Recruiting
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)
NSW,WA
Recruitment postcode(s) [1] 23233 0
6102 - Bentley
Recruitment postcode(s) [2] 23234 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 300048 0
Government body
Name [1] 300048 0
National Health and Medical Research Council
Address [1] 300048 0
Level 1, 16 Marcus Clarke Street, Canberra, ACT 2601
Country [1] 300048 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St, Bentley, WA 6102
Country
Australia
Secondary sponsor category [1] 299441 0
University
Name [1] 299441 0
Macquarie University
Address [1] 299441 0
Balaclava Road, North Ryde, NSW 2109
Country [1] 299441 0
Australia
Secondary sponsor category [2] 299446 0
University
Name [2] 299446 0
Monash University
Address [2] 299446 0
Wellington Road, Clayton, VIC 3800
Country [2] 299446 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300894 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 300894 0
Faculty of Health, Curtin University, Kent St, Bentley, WA 6102
Ethics committee country [1] 300894 0
Australia
Date submitted for ethics approval [1] 300894 0
14/01/2018
Approval date [1] 300894 0
06/02/2018
Ethics approval number [1] 300894 0
HRE2018-0062

Summary
Brief summary
The main aim of this RCT is to compare the clinical effectiveness and cost-effectiveness of individualised Cognitive Functional Therapy delivered with movement sensor biofeedback versus without movement sensor biofeedback, and also compared with usual care for patients with persistent, disabling LBP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85190 0
A/Prof Peter Kent
Address 85190 0
Curtin University, Kent St, Bentley, WA 6102
Country 85190 0
Australia
Phone 85190 0
+61 8 9266 4382
Fax 85190 0
Email 85190 0
peter.kent@curtin.edu.au
Contact person for public queries
Name 85191 0
A/Prof Peter Kent
Address 85191 0
Curtin University, Kent St, Bentley, WA 6102
Country 85191 0
Australia
Phone 85191 0
+61 8 9266 4382
Fax 85191 0
Email 85191 0
peter.kent@curtin.edu.au
Contact person for scientific queries
Name 85192 0
A/Prof Peter Kent
Address 85192 0
Curtin University, Kent St, Bentley, WA 6102
Country 85192 0
Australia
Phone 85192 0
+61 8 9266 4382
Fax 85192 0
Email 85192 0
peter.kent@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data and statistical code will be made available on request soon after each report of the data has been published.
When will data be available (start and end dates)?
Different aspects of the data will be published separately, which will determine when those data are publicly available. Broadly, individual participant data will be available from July 2022 to July 2027.
Available to whom?
The project lead (Peter Kent, peter.kent@curtin.edu.au).
Available for what types of analyses?
Secondary analyses.
By what mechanism will data be made available?
A data-sharing agreement will require a commitment to using the data only for specified research purposes, to securing the data appropriately and to destroying the data after a nominated period.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
Analytic code
Attachments/websites
Type [1] 1790 0
URL/details/comments [1] 1790 0
The detailed study protocol, informed consent form and ethics approval will be available at the end of the data collection period (to preserve participant blinding).
As different aspects of the data will be published separately, the statistical analysis plan and analytic code for each component will be separately publicly available after each component is completed.
A general protocol and analysis plan for the main trial aims well be submitted for publication in April 2019.
Attachment [1] 1790 0
Summary results
No Results