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Trial registered on ANZCTR


Registration number
ACTRN12619001134112
Ethics application status
Approved
Date submitted
29/07/2019
Date registered
14/08/2019
Date last updated
1/11/2019
Date data sharing statement initially provided
14/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
WalkBack - Effectiveness and cost-effectiveness of a progressive individualised walking and education program for the prevention of a recurrence of low back pain.
Scientific title
Is a progressive individualised walking and education program more effective when compared to usual care, in preventing recurrence of low back pain in people recently recovered from an episode of non-specific low back pain?
Secondary ID [1] 298416 0
none
Universal Trial Number (UTN)
U1111-1234-6968
Trial acronym
WalkBack
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrence of Low Back Pain 313134 0
Condition category
Condition code
Musculoskeletal 311609 311609 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 311610 311610 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the walking and education program will attend 3 face-to-face visits (baseline, 1 month and 3 months) with a trained physiotherapist. These session will be one-on-one, with the initial consult (baseline) taking approximately 45 minutes, whilst proceeding sessions (month 1 and 3) will take approximately 30 minutes. These sessions will require assessment of current walking capacity to enable tailoring of an individualised walking program. All programs will be tailored in collaboration with each participant, with the expectation that the walking program is carried out independently (i.e. in own time at home or location of their choice). The program will be progressed via either an increase in duration, number of steps, cadence or intensity (using Borg's RPE scale) - dependent on the participants preference with the aim of walking a minimum 5 times per week for 30 minutes by the end of the program. This is only a guide and can be exceeded or re-assessed based on each individuals capacity.

Participants will also receive education regarding strategies to prevent recurrences of low back pain (LBP) and pain education. These will be delivered both in the face-to-face sessions with the physiotherapist and over the phone. Participants will receive telephone-based health coaching (approximately 15 minutes) at 2 weeks, 9 weeks and a reinforcement session at 6 months, delivered by the same clinician who conducts the face-to-face sessions. Health coaching will be used to identify barriers and facilitators for compliance with the walking program and advice on how to address these. The health coaching will also focus on behaviour-change techniques, motivational interviewing, goal-setting and emphasis on enhancing engagement of individuals with the program based on their personal goals and priorities.

The program will include 2 core elements:

1. An individualised progressive walking program: Participants will be progressed individually based on their baseline walking level and fitness and on how they respond during the program. Initially participants will be encouraged to walk at a comfortable convenient pace with the emphasis on volume. As the participant progresses, they will be encouraged to increase the speed.

All participants will be provided with a pedometer and walking calendar to act as motivators in completing the program. The results recorded in the walking calendar will be used by the physiotherapist at face to face visits and over the phone coaching sessions, to help progress an individual’s walking program, discuss barriers and motivate compliance.

2. Education focusing on simple daily strategies to reduce the risk of a recurrence of LBP will also be provided. The strategies will be individualised based on the lifestyle of the individual and factors triggering previous episodes. However, based on evidence of risk factors the education will typically involve advice and strategies for avoiding sustained sitting, awkward positions and heavy lifting and education in optimal lifting techniques.

The education will also provide a modern understanding of LBP that reduces the threat and fear associated with pain. This aspect of the education is aimed at providing participants with the confidence and skills to manage small recurrences independently without the recurrence causing a significant impact on daily activities or need to seek care.

Throughout the 6-month intervention period, the physiotherapist will work with the participant to establish long-term goals and maintenance plans. This may include joining already-established recreational walking groups (e.g. Park Run, The Heart Foundation, etc).
Intervention code [1] 314669 0
Prevention
Comparator / control treatment
The control is usual care. Participants allocated to the usual care group will not receive any trial intervention as part of their involvement in the study.
Control group
Active

Outcomes
Primary outcome [1] 320310 0
Primary outcome: Days from randomisation to first self-reported recurrence of an episode of activity-limiting LBP, defined as a return of LBP lasting at least 24 hours with a pain intensity >2 (0-10 Numeric Pain Rating Scale), causing at least somewhat or greater interference with daily activities. Activity-limitation will be measured using an adaptation of item PI9 of the PROMIS item bank (How much did LBP interfere with your day to day activities?Answers: Not at all, A little, Somewhat, Quite a bit, Very much).
Timepoint [1] 320310 0
Time to first self-reported recurrence of an activity-limiting episode of low back pain (somewhat or greater activity limitation measured using an adaptation of item PI9 of the PROMIS item bank to measure pain interference). Participants will be followed-up for this outcome for between 12 and 36 months post-randomisation, depending on when they are randomised into the study. This outcome will be assessed monthly via a short online questionnaire. The analysis is a survival analysis.
Secondary outcome [1] 371188 0
Disability measured by the 24-point Roland Morris Disability Questionnaire.
Timepoint [1] 371188 0
All time points (i.e. 3, 6, 9 and 12 months follow-up assessments) post randomisation, Modelled using linear mixed model.
Secondary outcome [2] 371189 0
Days from randomisation to first self-reported recurrence of an episode of non-specific LBP (>2/10 on the numeric pain rating scale, lasting at least 24 hours, regardless of interference with daily activities).
Timepoint [2] 371189 0
Time to first self-reported recurrence of an episode of non-specific LBP (intensity >2/10 on the numeric pain rating scale, lasting at least 24 hours). Participants will be followed-up for this outcome for between 12 and 36 months post-randomisation, depending on when they are randomised into the study. This outcome will be assessed monthly via a short online questionnaire. The analysis is a survival analysis.
Secondary outcome [3] 371190 0
Days from randomisation to first self-reported recurrence of an episode of care seeking (with consultation to a health care provider) LBP.
Timepoint [3] 371190 0
At time of first self-reported recurrence of an episode of care seeking (with consultation to a health care provider) LBP. Participants will be followed-up for this outcome for between 12 and 36 months post-randomisation, depending on when they are randomised into the study. This outcome will be assessed monthly via a short online questionnaire. The analysis is a survival analysis.
Secondary outcome [4] 371191 0
Quality of Life measured by the EuroQoL (EQ5D-5L) instrument.
Timepoint [4] 371191 0
Measured at 3, 6, 9 and 12 months follow up assessments post randomisation.
Secondary outcome [5] 371192 0
Adverse events collected by self-report (Have you had a new medical condition or an exacerbation of an existing condition since the beginning of the study?).
Timepoint [5] 371192 0
Measured at 3 and 12 months follow-up assessments post randomisation.
Secondary outcome [6] 371193 0
Process measure 1 - Physical activity levels over the last week measured by a modified version of the International Physical Activity Questionnaire (IPAQ).
Timepoint [6] 371193 0
Measured at baseline, 3 and 12 months follow up assessments post randomisation.
Secondary outcome [7] 371194 0
Process measure 2: Minutes of physical activity of varying intensities measured over a 7 day period. Measured with the Actigraph GT3X-Plus accelerometer worn by all participants.
Timepoint [7] 371194 0
Measured for 7 consecutive days at 3 months post randomisation.
Secondary outcome [8] 371195 0
Process measure 3: Intentional walking duration in minutes (compliance measure for walking group only).
Timepoint [8] 371195 0
Self-reported and recorded daily in a walking calendar for 3 months post randomisation (later converted to a % of the weekly individual goal).
Secondary outcome [9] 371196 0
Process measure 4: Daily step count collected by a pedometer (compliance measure for walking group only).
Timepoint [9] 371196 0
Self-reported and recorded daily in a walking calendar for 3 months post randomisation (later converted to a % of the weekly individual goal).
Secondary outcome [10] 371197 0
Process measure 5: Any Co-interventions received. Collecting data on any intervention participants in both groups have received, in addition to the study intervention, to either prevent or treat LBP. This will be collected in a purpose-built survey.
Timepoint [10] 371197 0
Measured at 3, 6, 9 and 12 months follow up assessments post randomisation.
Secondary outcome [11] 373637 0
Process measure 6: Cost Data - Cost data will include health care utilisation (e.g. visits to health care providers, medication, and hospitalisation) and productivity loss (work absenteeism) due to LBP. This will be collected using a purpose-built patient reported survey assessing healthcare utilisation and absenteeism. The cost-effectiveness of analysis will be conducted form a societal perspective comparing the walking and education program to usual care using the primary outcome as the measure of effectiveness. An incremental cost-effectiveness ratio will be calculated by dividing the between group difference in costs by the between group difference in effects.
Timepoint [11] 373637 0
Measured at 3, 6, 9 and 12 months follow up assessments post randomisation.

Eligibility
Key inclusion criteria
Recovered from an episode of non-specific LBP within the last 6 months. An episode of non-specific LBP is defined as pain in the area between the 12th rib and buttock crease not attributed to a specific diagnosis such as vertebral fracture or cancer, lasting more than 24 hours with a pain intensity of >2/10 and causing at least somewhat or greater interference with day-to-day activities (measured using an adaptation of item PI9 of the PROMIS item bank to measure pain interference). Recovery is defined as >7 consecutive days with pain no greater than 1 on a 0-10 scale.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Co-morbidity preventing participation in a walking program.
- Currently walking for exercise 3 or more times per week for at least 30 minutes per day (at least 10 minutes on each occasion).
- Currently participating in an exercise program aiming to prevent recurrence of LBP.
- Currently achieving more than 150 mins of moderate or vigorous intensity physical activity weekly (across a minimum of 3 days/week).
- Inadequate English to complete outcome measures.
- Previous spinal surgery in the last 6 months.
- Currently pregnant

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised into either the intervention (walking & education) or control (usual care) group (1:1 ratio) using a randomisation schedule that has been pre-generated by a computer program. The randomisation schedule in redcap will be used to ensure concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation table will be created using a computer software (computer sequence generation). Randomly permuted blocks of 4, 6 and 8 and stratified allocation by history of > 2 previous lifetime episodes of LBP (known to be a risk factor for future episodes), and recruitment from the community or primary care will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
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: Sample size was calculated for the primary outcome using PASS software based on the method of Lakatos. Specifications include a two-sided log rank test, Type-I error = 0.05, power = 80%, 24-month accrual period, 12-month follow-up period. We presume a 30% recurrence rate at 12 months in the control group, a rate observed in our primary care study. Higher rates of recurrence typically reported in the literature and in our recent cohort study (unpublished) would increase power. We require 349 participants per group to detect a 25% relative reduction in recurrence rate (from 30% to 22.5%). A 25% relative reduction was a conservative estimate, but still large enough to have very important public health implications. We have allowed for 1% loss to follow-up per month, which exceeds that in our pilot data.

Treatment-Effectiveness Analysis: The primary analysis will assess difference in survival curves (days to recurrence) using the log-rank statistic. Cox regression will be used to assess the effect of treatment group on hazard ratios and to adjust for prognostic factors for LBP if these are unbalanced between groups despite randomisation. The proportional hazards assumption will be tested using the time-dependent covariate method. For the secondary outcome of time to recurrence an analogous survival analysis will be conducted. For continuous outcomes, multiple linear regression will be used to test for differences in means between groups, adjusted for potential confounders. Transformations will be applied if needed to meet model assumptions. Correlation between measurements within an individual will be considered for repeated measurements over time.

Cost-Effectiveness Analysis: The cost-effectiveness analysis will be conducted from the societal perspective and according to the intention-to-treat principle. It will compare the walking and education program to usual care using the primary outcome as the measure of effectiveness. We will use the model proposed by Latimer for survival analysis for economic evaluations alongside RCTs. An incremental cost-effectiveness ratio will be calculated by dividing the between-group difference in costs by the between-group difference in effects (i.e. costs per recurrence free month gained). Cost-effectiveness ratios will be estimated using bootstrapping techniques (5000 replications) and graphically presented on cost effectiveness planes. Acceptability curves and net monetary benefit will also be estimated.

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

Funding & Sponsors
Funding source category [1] 302964 0
Government body
Name [1] 302964 0
NHMRC project grant
Address [1] 302964 0
Levels 4-6 Medical Foundation Building, 92-94 Parramatta Rd, Camperdown NSW 2050
Country [1] 302964 0
Australia
Primary sponsor type
University
Name
Department of Health Professions - Faculty of medicine and Health Sciences - Macquarie University
Address
Ground Floor, 75 Talavera Rd - Macquarie University, NSW 2109, Australia
Country
Australia
Secondary sponsor category [1] 303452 0
None
Name [1] 303452 0
Address [1] 303452 0
Country [1] 303452 0
Other collaborator category [1] 280862 0
Other Collaborative groups
Name [1] 280862 0
Institute of Musculoskeletal Health
Address [1] 280862 0
PO Box M179, Missenden Road, 2050. Sydney, NSW, Australia.
Country [1] 280862 0
Australia
Other collaborator category [2] 280863 0
University
Name [2] 280863 0
University of Sydney
Address [2] 280863 0
Sydney School of Public Health, Edward Ford Building, A27 Fisher Rd, University of Sydney, NSW, 2006, Australia.
Country [2] 280863 0
Australia
Other collaborator category [3] 280864 0
University
Name [3] 280864 0
Western Sydney University
Address [3] 280864 0
School of Science and Health, Campbelltown Campus, Locked Bag 1797. Sydney, NSW, Australia
Country [3] 280864 0
Australia
Other collaborator category [4] 280865 0
University
Name [4] 280865 0
Vrije Universiteit
Address [4] 280865 0
De Boelelaan 1105, 1081 HV Amsterdam, Netherlands
Country [4] 280865 0
Netherlands

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303518 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 303518 0
Research office - Level 3, 17 Wally’s Walk - Macquarie University, NSW 2109, Australia
Ethics committee country [1] 303518 0
Australia
Date submitted for ethics approval [1] 303518 0
18/02/2019
Approval date [1] 303518 0
03/05/2019
Ethics approval number [1] 303518 0
5201949218164

Summary
Brief summary
WalkBack is a pragmatic randomised controlled trial comparing a walking and education program prescribed over 6 session by a physiotherapist, with a usual care control group. 698 participants, who have recently recovered from an episode of non-specific low back pain, will be recruited through the community and primary care clinicians (GPs, physiotherapists and chiropractors). Participants will be followed up for a minimum of 12 months. The primary outcome will be days from randomisation to first self-reported recurrence of an episode of activity-limiting LBP (somewhat or greater activity limitation measured using an adaptation of item PI9 of the PROMIS item bank to measure pain interference). The secondary outcomes will be days from randomisation to first self-reported recurrence of (i) an episode of non-specific LBP (intensity equal or greater than 3/10 on the numeric pain rating scale, lasting at least 24 hours), (ii) an episode of care seeking (with consultation to a health care provider) LBP and back pain related-disability measured by the 24-points Roland-Morris Disability Questionnaire (RMDQ). An assessment of effectiveness and cost effectiveness of the walking and education program compared to usual care will then occur.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93942 0
Prof Mark Hancock
Address 93942 0
Department of Health Professions - Faculty of Medicine and Health Sciences - Ground floor, 75 Talavera road - Macquarie University - MACQUARIE UNIVERSITY - NSW - 2109
Country 93942 0
Australia
Phone 93942 0
+61 2 9850 6622
Fax 93942 0
+61 2 9850 6630
Email 93942 0
mark.hancock@mq.edu.au
Contact person for public queries
Name 93943 0
Ms Natasha Pocovi
Address 93943 0
Department of Health Professions - Faculty of Medicine and Health Sciences - Ground floor, 75 Talavera road - Macquarie University - MACQUARIE UNIVERSITY - NSW - 2109
Country 93943 0
Australia
Phone 93943 0
+61 2 9850 2794
Fax 93943 0
+61 2 9850 6630
Email 93943 0
tash.pocovi@mq.edu.au
Contact person for scientific queries
Name 93944 0
Prof Mark Hancock
Address 93944 0
Department of Health Professions - Faculty of Medicine and Health Sciences - Ground floor, 75 Talavera road - Macquarie University - MACQUARIE UNIVERSITY - NSW - 2109
Country 93944 0
Australia
Phone 93944 0
+61 2 9850 6622
Fax 93944 0
+61 2 9850 6630
Email 93944 0
mark.hancock@mq.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?
All of the de-identified individual participant data collected during the trial and statistical code will be made available on request. Different aspects of the data will be published separately, which will determine when particular information is publicly available.
When will data be available (start and end dates)?
Data for this trial will be available on request soon after each report of the data has been published. There will be no end date for availability of data.
Available to whom?
Access to study data will be available to anyone who provides a methodologically sound proposal for its use and has ethical approval and will be based on a case-by-case as decided by the Primary Investigators.
Available for what types of analyses?
Any type of analysis.
How or where can data be obtained?
Data access will be made available via contacting study Principal Investigators (mark.hancock@mq.edu.au). Data access will be subject to approvals by the Principal Investigators and after signing a data-sharing agreement.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 3861 0
Study protocol
Citation [1] 3861 0
Link [1] 3861 0
Email [1] 3861 0
mark.hancock@mq.edu.au
Other [1] 3861 0
Protocol will be published in an open-access journal in the future.
Attachment [1] 3861 0
Type [2] 3862 0
Statistical analysis plan
Citation [2] 3862 0
Although the statistical analysis plan can be requested via email, the protocol will be published in an open-access journal in the future that will also host a statistical analysis plan.
Link [2] 3862 0
Email [2] 3862 0
mark.hancock@mq.edu.au
Other [2] 3862 0
Attachment [2] 3862 0
Type [3] 3863 0
Clinical study report
Citation [3] 3863 0
Link [3] 3863 0
Email [3] 3863 0
mark.hancock@mq.edu.au
Other [3] 3863 0
Attachment [3] 3863 0
Type [4] 3864 0
Ethical approval
Citation [4] 3864 0
Link [4] 3864 0
Email [4] 3864 0
mark.hancock@mq.edu.au
Other [4] 3864 0
Attachment [4] 3864 0
Summary results
No Results