ANZCTR - Registration

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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

Date results information 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]

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

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

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]

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]

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]

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]

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]

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]

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]

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]

All time points (i.e. 3, 6, 9 and 12 months follow up assessments) post randomisation, Modelled using linear mixed model.

Secondary outcome [4]

Secondary Outcome 4: Process measure 1 - Physical activity levels over the last week measured by the International Physical Activity Questionnaire (IPAQ).

Timepoint [4]

Measured at baseline, 3 and 12 months follow up assessments post randomisation.

Secondary outcome [5]

Secondary Outcome 5: Process measure 2 - Study program compliance over the last 3 months measured by the Brief Adherence Rating Scale.

Timepoint [5]

Measured at 3, 6, 9 and 12 months follow up assessments post randomisation.

Secondary outcome [6]

Secondary Outcome 6: Process measure 3 – Credibility expectancy about treatment measured by the Credibility Expectancy Questionnaire (CEQ).

Timepoint [6]

Measured at 3 months follow up assessments post randomisation.

Secondary outcome [7]

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]

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?

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]

Charities/Societies/Foundations

Name [1]

International Mechanical Diagnosis and Therapy Research Foundation

Address [1]

Mailing Address: The International MDT Research Foundation
PO Box 98116
Raleigh NC 27624

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Human Research Ethics Committee

Ethics committee address [1]

Research Office - Research Hub, Building C5C East - Macquarie University - North Ryde - NSW - 2109

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/03/2016

Approval date [1]

21/04/2016

Ethics approval number [1]

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

Prof Mark Hancock

Address

Department of Health Professions
Faculty of Medicine and Health Sciences
Ground Floor, 75 Talavera Road - Macquarie University
NORTH RYDE - NSW - 2109

Country

Australia

Phone

+61 2 9850 6622

Fax

+61 2 9850 6630

[email protected]

Contact person for public queries

Name

Mr Tarcisio Folly de Campos

Address

Department of Health Professions
Faculty of Medicine and Health Sciences
Ground Floor, 75 Talavera Road - Macquarie University
NORTH RYDE - NSW - 2109

Country

Australia

Phone

+61 2 9850 6617

Fax

+61 2 9850 6630

[email protected]

Contact person for scientific queries

Name

Prof Mark Hancock

Address

Department of Health Professions
Faculty of Medicine and Health Sciences
Ground Floor, 75 Talavera Road - Macquarie University
NORTH RYDE - NSW - 2109

Country

Australia

Phone

+61 2 9850 6622

Fax

+61 2 9850 6630

[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.	Type	Citation	Link	Email	Other Details	Attachment
2204	Study 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

Source	Title	Year of Publication	DOI
Embase	Prognosis of a new episode of low-back pain in a community inception cohort.	2023	https://dx.doi.org/10.1002/ejp.2083

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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