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Trial registered on ANZCTR


Registration number
ACTRN12616000926437
Ethics application status
Approved
Date submitted
5/07/2016
Date registered
12/07/2016
Date last updated
31/05/2019
Date data sharing statement initially provided
31/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
SAFE – Effectiveness of Mckenzie based self-management for the secondary prevention of a recurrence of low back pain.
Scientific title
Is McKenzie based self-management more effective than advice, in preventing recurrence of low back pain, in people who have recently recovered from an episode of non-specific low back pain?
Secondary ID [1] 289594 0
Nil Known
Universal Trial Number (UTN)
U1111-1184-9436
Trial acronym
SAFE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrence of Low Back Pain 299363 0
Condition category
Condition code
Musculoskeletal 299351 299351 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 299393 299393 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the McKenzie based self-management approach group will attend 2 x 30 minute individual sessions with a trained physiotherapist. These sessions will be approximately 2 weeks apart. The participant will be trained in an individualised simple specific exercise program focusing on movements that balance/counteract the postures or positions used throughout the day. Since the intervention is individualised for each participant, the exercises to be completed at home will vary in frequency and duration based on the judgement of the assessing physiotherapist to suit each individual's case. The intended exercises are aimed at changing habits, therefore therapists will emphasise the importance of continuing these exercises indefinitely as a prevention strategy for back pain recurrence. For most people the exercise program will involve lumbar extension to counteract the large amount of flexion activity typical of most people’s lives either in sitting or manual tasks, following a McKenzie approach. Adherence will be monitored by 1) recording attendance to physiotherapy visits, 2) asking physiotherapists to rate their perception of participant compliance to the home exercise program between the participants initial and final visit (2 weeks period) and 3) asking participants to rate compliance with home program using the Brief Adherence Rating Scale at 3, 6, 9 and 12 month follow-ups.
Intervention code [1] 295200 0
Prevention
Comparator / control treatment
Participants allocated to minimal intervention group will receive simple advice about how to prevent back pain over the phone by a physiotherapist (key points being to stay active and to use good postures, taking approximately 10-15 minutes) and will also be posted the “Managing Back Pain – get back on track” booklet. Participants will have the opportunity to contact the physiotherapist on one further occasion by email or phone if they require further clarification of the information.
Control group
Active

Outcomes
Primary outcome [1] 298820 0
Primary Outcome: 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).
Timepoint [1] 298820 0
At time of first self-reported recurrence of an episode of activity limiting 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 30 months post-randomisation, depending on when they are randomised into the study.

The analysis is a survival analysis.
Secondary outcome [1] 325301 0
Secondary Outcome 1: Days from randomisation to first self-reported recurrence of an episode of non-specific LBP (intensity equal or greater than 3/10 on the numeric pain rating scale, lasting at least 24 hours).
Timepoint [1] 325301 0
At time of first self-reported recurrence of an episode of non-specific LBP (intensity equal or greater than 3/10 on the numeric pain rating scale, lasting at least 24 hours). Participants will be followed-up for this outcome for between 12 and 30 months post-randomisation, depending on when they are randomised into the study.

The analysis is a survival analysis.
Secondary outcome [2] 325302 0
Secondary Outcome 2: Days from randomisation to first self-reported recurrence of an episode of care seeking (with consultation to a health care provider) LBP.
Timepoint [2] 325302 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 30 months post-randomisation, depending on when they are randomised into the study.

The analysis is a survival analysis.
Secondary outcome [3] 325303 0
Secondary Outcome 3: Impact of back pain measured by the Impact of Back Pain Questionnaire using 9 items of the 29-item PROMIS form.
Timepoint [3] 325303 0
All time points (i.e. 3, 6, 9 and 12 months follow up assessments) post randomisation, Modelled using linear mixed model.
Secondary outcome [4] 325304 0
Secondary Outcome 4: Process measure 1 - Physical activity levels over the last week measured by the International Physical Activity Questionnaire (IPAQ).
Timepoint [4] 325304 0
Measured at baseline, 3 and 12 months follow up assessments post randomisation.
Secondary outcome [5] 325305 0
Secondary Outcome 5: Process measure 2 - Study program compliance over the last 3 months measured by the Brief Adherence Rating Scale.
Timepoint [5] 325305 0
Measured at 3, 6, 9 and 12 months follow up assessments post randomisation.
Secondary outcome [6] 325306 0
Secondary Outcome 6: Process measure 3 – Credibility expectancy about treatment measured by the Credibility Expectancy Questionnaire (CEQ).
Timepoint [6] 325306 0
Measured at 3 months follow up assessments post randomisation.
Secondary outcome [7] 325307 0
Secondary Outcome 7: 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?). Examples of possible risks include short term muscle soreness with starting a new exercise program, or recurrence of the previous back pain.
Timepoint [7] 325307 0
Measured at 3 and 12 months follow up assessments post randomisation.

Eligibility
Key inclusion criteria
(i) Recently recovered from a previous episode of non-specific LBP (with or without leg pain) within the last 6 months. 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 (ankylosing spondylitis, vertebral fracture, etc). Recovery is described as occurring after 7 consecutive days with pain no greater than 1 on a 0-10 numeric pain scale; (ii) Participants at least 18 years old; (iii) currently not taking any medication for low back pain.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous spinal surgery;
* Co-morbidity restricting or preventing safe participation in exercise (screened using Physical Activity Readiness Questionnaire (PARQ+);
* Inadequate English to complete outcome measures;
* Previously exposed to McKenzie based self-management approach as a method of preventing future low back pain;
* 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)
After agreeing to participate and providing verbal consent, participants will undergo a baseline assessment over the phone. This will take approximately 10 minutes and collect data on demographics, history of LBP and risk factors for recurrence as per the baseline assessment booklet.
Participants will be randomly allocated into either Mckenzie based self-management approach or minimal intervention control group immediately after doing the baseline assessment. The researcher will open the next consecutively numbered, sealed opaque randomisation envelope to ensure concealed allocation.
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, not involved in allocating or following up participants, using a computer program prior to the commencement of the trial. The randomisation schedule will be developed using randomly permutated blocks. Randomisation will be stratified by the number of previous episodes of low back pain (more than 2 episodes).
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
The sample size was calculated for the primary outcome using PASS software based upon the method of Lakatos (Lakatos, 1988). For a two-sided log rank test with an alpha value of 0.05 we calculated that a sample size of 131 participants per group will give 80% power to detect a 40% relative reduction in recurrence rates between the treatment group and the control group. These calculations are based upon 40% recurrence in 1 year in the control group. Our sample size calculations are based on a 24 month accrual period and 12 month follow up period. We have conservatively allowed for 1% loss to follow-up, and 1% treatment non-compliance per month in both groups. (NB in the survival analysis module of PASS software loss to follow-up and treatment non-compliance are specified per unit of study time which in this case is months.)
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 activity limitation due to back pain) using the log-rank statistic. Cox regression will be used to assess the effect of treatment group on hazard ratios.
Linear mixed models will be used to assess the outcome of Impact of Back Pain over the 12 month follow up period

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/07/2016
Actual
15/07/2016
Date of last participant enrolment
Anticipated
1/07/2018
Actual
21/06/2018
Date of last data collection
Anticipated
14/12/2018
Actual
28/05/2019
Sample size
Target
262
Accrual to date
Final
262
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293981 0
Charities/Societies/Foundations
Name [1] 293981 0
International Mechanical Diagnosis and Therapy Research Foundation
Country [1] 293981 0
United States of America
Primary sponsor type
University
Name
Macquarie University
Address
Ground Floor,75 Talavera Road - Macquarie University - North Ryde - NSW – 2109
Country
Australia
Secondary sponsor category [1] 292798 0
None
Name [1] 292798 0
Address [1] 292798 0
Country [1] 292798 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295399 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 295399 0
Research Office - Research Hub, Building C5C East - Macquarie University - North Ryde - NSW - 2109
Ethics committee country [1] 295399 0
Australia
Date submitted for ethics approval [1] 295399 0
09/03/2016
Approval date [1] 295399 0
21/04/2016
Ethics approval number [1] 295399 0
5201600187

Summary
Brief summary
SAFE will be a pragmatic randomised controlled trial comparing, a McKenzie based self-management method where participants in the intervention group will attend 2 x 30 minute individual sessions with a trained physiotherapist and the control group will receive advice delivered over the phone and an educational booklet on how to manage back pain. 396 participants, who have recently recovered from an episode of non-specific low back pain, will be recruited through community and website advertisement 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 impact of back pain measured by the Impact of Back Pain Questionnaire using 9 items of the 29-item PROMIS form.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67126 0
Prof Mark Hancock
Address 67126 0
Department of Health Professions
Faculty of Medicine and Health Sciences
Ground Floor, 75 Talavera Road - Macquarie University
NORTH RYDE - NSW - 2109
Country 67126 0
Australia
Phone 67126 0
+61 2 9850 6622
Fax 67126 0
+61 2 9850 6630
Email 67126 0
[email protected]
Contact person for public queries
Name 67127 0
Tarcisio Folly de Campos
Address 67127 0
Department of Health Professions
Faculty of Medicine and Health Sciences
Ground Floor, 75 Talavera Road - Macquarie University
NORTH RYDE - NSW - 2109
Country 67127 0
Australia
Phone 67127 0
+61 2 9850 6617
Fax 67127 0
+61 2 9850 6630
Email 67127 0
[email protected]
Contact person for scientific queries
Name 67128 0
Mark Hancock
Address 67128 0
Department of Health Professions
Faculty of Medicine and Health Sciences
Ground Floor, 75 Talavera Road - Macquarie University
NORTH RYDE - NSW - 2109
Country 67128 0
Australia
Phone 67128 0
+61 2 9850 6622
Fax 67128 0
+61 2 9850 6630
Email 67128 0
[email protected]

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. Different aspects of the data will be published separately, which will determine when those data are 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. We plan to finish data collection by July 2019 and data will be available up to 5 years after data collection has finished.
Available to whom?
Access to study data will be available to anyone who provides a methodologically sound proposal for its use and will be based on a case-by-case decision of 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. Data access will be subject to approvals by Principal Investigators and after signing a data-sharing agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2204Study protocol    https://doi.org/10.1093/ptj/pzx046



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePrognosis of a new episode of low-back pain in a community inception cohort.2023https://dx.doi.org/10.1002/ejp.2083
N.B. These documents automatically identified may not have been verified by the study sponsor.