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Trial registered on ANZCTR


Registration number
ACTRN12615000939594
Ethics application status
Approved
Date submitted
19/08/2015
Date registered
8/09/2015
Date last updated
23/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
TOPS: Trial Of Prevention Strategies for low back pain in patients recently recovered from low back pain
Scientific title
In patients recently recovered from low back pain, is a 12-week group exercise and education program, compared to a minimal 30-minute advice session, effective and cost–effective at reducing the rate of recurrence of low back pain?
Secondary ID [1] 287312 0
nil
Universal Trial Number (UTN)
Trial acronym
TOPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain recurrence 295946 0
Condition category
Condition code
Musculoskeletal 296219 296219 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 296309 296309 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group exercise and education program

Participants in the group exercise and education program are to receive a comprehensive, individualised exercise and education program over 12 weeks. This includes a single 1-hour clinical assessment session followed by an 8 week supervised group exercise program that is both graded and progressed. The group sessions will be conducted once per week and will run for one hour. The program will run at a ratio of between 3 - 8 participants per exercise provider. The program will also include three half-hour one-on-one sessions with the exercise provider to implement and monitor a home exercise program. These sessions will occur at four, eight and 12 weeks. The home exercise program will build upon the exercises conducted within the sessions and facilitate continuation of exercises once the supervised group exercise program has been completed. After completion of the 12-week program, weekly education and/or motivational tips will be sent to participants via phone (short message service; SMS) or email according to the participant’s preference for another 12-week period.

The exercises / activities implemented as a part of this intervention will focus on four key areas of exercise training identified by the American College of Sports Medicine (ACSM). These are:

1. Cardiorespiratory exercises
2. Resistance exercises
3. Flexibility exercises
4. Neuromotor exercises

All participants will be directed to meet the American College of Sports Medicine’s guidelines for cardiorespiratory exercise with specific resistance, flexibility and neuromotor components implemented according to areas of deficit identified in the initial assessment. The progression of the program will conform to the American College of Sports Medicine’s position statement.

Clinical Assessment
The clinical assessment session to plan the individualised exercise program will occur within one week of the baseline assessment. The purpose of the assessment session is to enable the exercise provider to determine the appropriate level (quantity and intensity) of exercises and general activity most suitable for the participant. Also, within the assessment session will be time to develop a home exercise program consistent with the ACSM principles.

Group component
Exercises conducted in the group sessions will focus on increasing strength, endurance and coordination of the trunk musculature. Specific exercises in the program may focus on a single area or include aspects from two or more areas above and will emphasise performance of functional everyday activities. Exercise providers will work with participants to provide an individualised and graded exercise program that reflects the participant’s physical capacity and the nature of the work, household, social and sporting activities the participant is involved in. All exercises will be conducted using the participant’s current level of fitness and ability as a starting point, and progress using the position statement on Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise as a guide. Exercise providers will use their clinical judgement to determine what aspects of exercise (cardiorespiratory, resistance, flexibility and neuromotor) to concentrate on in the group sessions.

Educational component
The educational component will consist of a number of elements:

1. A basic understanding of anatomy and kinesiology
2. Postural and movement education
3. Causes and management of LBP
4. Benefits of exercise
5. Motivational ideas

The educational components will be delivered in two ways. The first will be conducted as part of the group classes, integrated with the provision of exercises such that while the participant is learning to perform the exercise they are also learning the theory behind what they are doing and why it is important for them. This will help in retaining the key principles of both the exercise and the education and assist in self-identification of any possible deconditioning that may occur after the exercise program has been completed. A series of ‘education tips’ have been developed to focus the education points around a different aspect at each exercise session. The second educational component will be conducted from weeks 14 through 26 with the purpose of reinforcing the education received in the classes and maintaining compliance with the exercise program beyond completion of the 12-week program. These messages will be delivered by SMS or email depending on the participants’ preference.

Home exercise prescription
Participants will be given four separate opportunities to develop, discuss and revise their home exercise program in individual (ie one-on-one) consultations with their exercise provider. Compliance with the program will be also checked weekly at the group sessions. The aim of the home exercise program is to progress the participants activity to a level that is consistent with the ACSM’s position statement and enable participants to continue exercising at this level beyond the duration of the group exercise program.
Intervention code [1] 292630 0
Prevention
Intervention code [2] 292704 0
Rehabilitation
Comparator / control treatment
Participants will receive one half-hour appointment with the exercise provider where they will be provided with, and discuss, the ‘Guide to Positively Managing Back Pain’ booklet. Included in this time will be opportunity for the participant to ask any questions they might have about the booklet or its contents. Participants will have the opportunity to contact the exercise provider by phone on one occasion after the end of the session to clarify the information contained in the booklet or ask further questions. In order to maintain the minimalist nature of this intervention exercise providers conducting the intervention are not to volunteer information that goes beyond the scope of the booklet.

The ‘Guide to Positively Managing Back Pain’ booklet has been developed by BUPA whom have given approval for its use in this study. It is a publicly available resource that includes advice on self-management and prevention of back pain as well as a brief overview of types of exercise.
Control group
Active

Outcomes
Primary outcome [1] 295883 0
Days from randomisation to first self-reported recurrence of an episode of low back pain (defined as back pain lasting at least 24hrs with a pain intensity of 3 or more on a 0-10 numeric pain rating scale).
Timepoint [1] 295883 0
Collected fortnightly for a minimum of 1 year from randomisation up until completion of the study
Primary outcome [2] 295884 0
Cost-effectiveness analysis using the cost of the intervention and cost of a recurrence (Secondary Outcome 4) to generate cost and Primary Outcome 1 as the measure of effectiveness.
Timepoint [2] 295884 0
Analysis conducted on completion of all data collection
Secondary outcome [1] 316819 0
Days from randomisation to first self-reported recurrence of an episode of low back pain resulting in work absence of at least one day (for those in paid employment)
Timepoint [1] 316819 0
Collected fortnightly for a minimum of 1 year from randomisation up until completion of the study
Secondary outcome [2] 316820 0
Days from randomisation to first self-reported recurrence of an episode of consulting low back pain (with consultation to a health care provider)
Timepoint [2] 316820 0
Collected fortnightly for a minimum of 1 year from randomisation up until completion of the study
Secondary outcome [3] 316821 0
Days from randomisation to first self-reported recurrence of an episode of activity limiting low back pain (moderate or greater activity limitation measured using an adaptation of item 8 of the SF-36)
Timepoint [3] 316821 0
Collected fortnightly for a minimum of 1 year from randomisation up until completion of the study
Secondary outcome [4] 316822 0
Work absenteeism due to recurrence of low back pain collected by self-report diary
Timepoint [4] 316822 0
Everything for 3 months post recurrence of an episode of low back pain (recurrence of an episode of low back pain will be monitored from randomisation for a minimum of 1 year until completion of the study as defined in Primary Outcome 1)
Secondary outcome [5] 316823 0
Process measure 1: Physical activity levels measured using the Actigraph GT3X (an accelerometer)
Timepoint [5] 316823 0
measured at baseline, 6 and 12 months
Secondary outcome [6] 316824 0
Process measure 2: Back pain beliefs measured by the Back Pain Beliefs Questionnaire
Timepoint [6] 316824 0
measured at baseline, 6 and 12 months
Secondary outcome [7] 316825 0
Back pain intensity over the past 4 weeks measured using an adaption of item 7 of the SF-36
Timepoint [7] 316825 0
measured at 6 and 12 months
Secondary outcome [8] 316826 0
Back pain interference with work over the 4 weeks measured using an adaption of item 8 of the SF-36
Timepoint [8] 316826 0
measured at 6 and 12 months
Secondary outcome [9] 316827 0
Adverse events will be collected by self-report (Have you had a new medical condition or an exacerbation of an existing condition since beginning the study, e.g. dizziness?)
Timepoint [9] 316827 0
Collected 14 weeks post randomisation
Secondary outcome [10] 317058 0
Healthcare utilisation due to recurrence of low back pain collected by self-report diary
Timepoint [10] 317058 0
Everything for 3 months post recurrence of an episode of low back pain (recurrence of an episode of low back pain will be monitored from randomisation for a minimum of 1 year until completion of the study as defined in Primary Outcome 1)

Eligibility
Key inclusion criteria
Recovered from a previous episode of non-specific LBP within the last 3 months. Non-specific low back pain is defined as pain in the area of the back between the 12th rib and buttock crease not attributable to a specific diagnosis such as sciatica, or a serious spinal pathology such as ankylosing spondylitis, vertebral fracture, spinal tumour etc. The date of recovery is defined as the 7th consecutive day with pain no greater than 1 on a 0-10 pain scale.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous spinal surgery.
- Any co-existing medical condition that would restrict or prevent safe participation in the exercise program using the Physical Activity Readiness Questionnaire Plus (PARQ+) as a guide.
- Inadequate English to complete outcome measures.
- Currently participating in an exercise program similar to the one to be evaluated in the current trial.
- Unable to collect valid data for all baseline measures.
- Currently pregnant
- Less than 18 years of age

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 randomly allocated to one of two treatment groups. Consecutively numbered, sealed, opaque envelopes will be used to conceal randomisation.
Allocation will occur immediately following the baseline assessment. At this time, the researcher conducting the baseline assessment will give the envelope containing the allocation to the exercise provider. The researcher will record the participant number, time and place of randomisation and then leave. The exercise provider will open the envelope and record both the randomisation number and treatment group. The exercise provider will organise for the provision of the prescribed intervention, either minimal intervention or group exercise. Participants will be considered to have entered the study at the time that the envelope is given to the exercise provider.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to treatment group. The randomisation schedule will be generated by an independent investigator using a computer program prior to the commencement of the trial. The randomisation schedule will be developed using permutated blocks. Randomisation will be stratified by the number of previous episodes of low back pain (more than 2 episodes) and for each cohort. (This study includes 3 distinct populations undergoing an identical protocol. These are: working population, defence force or primary care.) Consecutively numbered, sealed, opaque envelopes will be used to conceal randomisation.
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
TOPS will potentially incorporate 3 separate cohorts. We have funding from NSW WorkCover to enrol 160 workers (TOPS Workers). We have a pending application with NHMRC to enrol 1,022 patients from primary care (TOPS Primary Care) and with Defence Health Foundation to enrol 300 defence service personnel (TOPS Defence). Our plan is to use the same trial protocol for the three cohorts and if full funding is secured report the results as one trial enrolling 1,482 participants.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Each cohort (workers, defence and primary care) has been independently powered to detect a clinically significant result for the primary outcome. Sample size was calculated for the primary outcome using PASS software based on the method of Lakatos by means of a two-sided log rank test with an alpha value of 0.05. For the workers cohort we calculated that a sample size of 80 participants per group will give 80% power to detect a 40% relative reduction in recurrence rates between the treatment group and the control group. For the defence cohort 150 participants per group will provide 80% power to detect a 30% relative reduction between treatment groups and for the primary care cohort 511 participants per group will provide 80% power to detect a 20% relative reduction between groups. Pooling the data from all 1482 participants will provide 80% power to detect a 15% relative reduction between the treatment groups. These calculations are based upon 30% recurrence in 1 year in the control group. We have allowed for 1% loss to follow-up, and 1% treatment non-compliance per month in both groups.

Data will be analysed by a statistician who is blinded to group status. The primary analyses will be by intention-to-treat. For the primary outcome, a P value of <0.05 will be considered statistically significant. For the secondary outcomes a P value of <0.01 will be considered significant. We will assess difference in survival curves (days to recurrence of episode of work absence due to back pain) using the log-rank statistic. Cox regression will be used to assess the effect of treatment group on hazard ratios.

The cost-effectiveness analysis will be conducted from the societal perspective and according to the intention-to-treat principle. It will compare group exercise to minimal intervention using the primary outcome as the measure of effectiveness. Costs will include costs of the intervention, costs of health care utilization due to low back pain and costs of work absenteeism. Costs of the study treatment will be measured bottom-up and derived from the cost of providing the intervention plus the cost of equipment purchased.

Full details will be available in the published protocol / statistical analysis plan.

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] 291876 0
Government body
Name [1] 291876 0
WorkCover NSW
Address [1] 291876 0
92-100 Donnison St, Gosford, NSW, Australia 2250
Country [1] 291876 0
Australia
Funding source category [2] 295408 0
Charities/Societies/Foundations
Name [2] 295408 0
Defence Health Foundation
Address [2] 295408 0
Defence Health Foundation
PO Box 7518
Melbourne VIC 3004
Country [2] 295408 0
Australia
Primary sponsor type
University
Name
The George Institute for Global Health, Sydney Medical School, The University of Sydney
Address
GPO Box 5389, Sydney, NSW, Australia 2001
Country
Australia
Secondary sponsor category [1] 290542 0
None
Name [1] 290542 0
Address [1] 290542 0
Country [1] 290542 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293383 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 293383 0
Level 6, Jane Foss Russell, The University of Sydney, NSW 2006 Australia
Ethics committee country [1] 293383 0
Australia
Date submitted for ethics approval [1] 293383 0
17/08/2015
Approval date [1] 293383 0
28/09/2015
Ethics approval number [1] 293383 0
2015:728
Ethics committee name [2] 296741 0
Australian Defence Human REsearch Ethics Committee
Ethics committee address [2] 296741 0
CP3-6-036
Campbell Park Offices
PO Box 7912
Canberra BC ACT 2610
Ethics committee country [2] 296741 0
Australia
Date submitted for ethics approval [2] 296741 0
17/05/2016
Approval date [2] 296741 0
08/08/2016
Ethics approval number [2] 296741 0
822-16

Summary
Brief summary
TOPS will be a pragmatic comparative effectiveness randomised controlled trial with a parallel economic evaluation. It will combine three separate cohorts (TOPS Workers, TOPS Primary Care, TOPS Defence), pending funding approval, using an identical methodology. 1482 participants who have recently recovered from low back pain will be randomised to either a comprehensive exercise and education program conducted over 12 weeks, consisting of a single one-hour assessment session, 3 individual half-hour education sessions and 8 one-hour supervised group exercise sessions; or a minimal intervention consisting of the ‘Guide to Positively Managing Back Pain’ booklet and one 30 minute education and advice session. Participants will be followed up for a minimum of 1 year. The primary outcome will be days till recurrence of low back pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59342 0
Prof Chris Maher
Address 59342 0
The George Institute for Global Health
PO Box M201, Missenden Road, Sydney NSW 2050
Country 59342 0
Australia
Phone 59342 0
+61 2 9657 0382
Fax 59342 0
Email 59342 0
cmaher@george.org.au
Contact person for public queries
Name 59343 0
Mr Matthew Stevens
Address 59343 0
The George Institute for Global Health
GPO Box 5389, Sydney, NSW, Australia 2001
Country 59343 0
Australia
Phone 59343 0
Tel: +61 2 96570346
Fax 59343 0
Email 59343 0
mstevens@georgeinstitute.org.au
Contact person for scientific queries
Name 59344 0
Prof Chris Maher
Address 59344 0
The George Institute for Global Health
GPO Box 5389, Sydney, NSW, Australia 2001
Country 59344 0
Australia
Phone 59344 0
+61 2 9657 0382
Fax 59344 0
Email 59344 0
cmaher@george.org.au

No information has been provided regarding IPD availability
Summary results
No Results