Evidence map›Paper›PMID 36927497›Full record

Trial reportTrials2023

Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial.

Natasha C Pocovi, Petra L Graham, Chung-Wei Christine Lin, Simon D French, Jane Latimer, Dafna Merom, Anne Tiedemann, Christopher G Maher, Johanna M van Dongen, Ornella Clavisi and 1 more

Open access · goldFull text readRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
1.0field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 4 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 2 countries.

Natasha C PocoviDepartment of Health Sciences, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, Australia. tash.pocovi@mq.edu.au.ORCID http://orcid.org/0000-0003-0617-7707
Petra L GrahamSchool of Mathematical and Physical Sciences, Macquarie University, Sydney, Australia.
Chung-Wei Christine LinThe University of Sydney, Sydney Musculoskeletal Health, Gadigal Country, Sydney, Australia.
Simon D FrenchDepartment of Chiropractic, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, Australia.
Jane LatimerThe University of Sydney, Sydney Musculoskeletal Health, Gadigal Country, Sydney, Australia.
Dafna MeromSchool of Health Sciences, Western Sydney University, Sydney, Australia.
Anne TiedemannThe University of Sydney, Sydney Musculoskeletal Health, Gadigal Country, Sydney, Australia.
Christopher G MaherThe University of Sydney, Sydney Musculoskeletal Health, Gadigal Country, Sydney, Australia.
Johanna M van DongenDepartment of Health Sciences, Vrije University of Amsterdam, Amsterdam, Netherlands.
Ornella ClavisiMusculoskeletal Australia, Melbourne, VIC, Australia.
Mark J HancockDepartment of Health Sciences, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, Australia.
Macquarie University · AUThe University of Sydney · AUAustralian Institute for Musculoskeletal Science · AUVrije Universiteit Amsterdam · NLWestern Sydney University · AU

Funding

Emerging Leadership Fellowship from the NHMRC APP1193939National Health and Medical Research Council APP1161889
6 · The paper itself

Abstract

backgroundExercise for the prevention of low back pain recurrences is recommended, but under-researched. The effectiveness and cost-effectiveness of a walking program for preventing low back pain recurrence remains unknown. This a priori statistical analysis plan describes the methods of analysis for the WalkBack trial.

methodsWalkBack is a prospectively registered, pragmatic, randomised controlled trial. The aim is to investigate the effectiveness and cost-effectiveness of a 6-month progressive and individualised walking and education program (intervention) for the prevention of low back pain recurrences, compared to a no-treatment control group. The primary outcome is days to the first recurrence of an episode of activity-limiting low back pain. Key secondary outcomes include days to any recurrence of low back pain, days to a care-seeking recurrence of low back pain, disability level, health-related quality of life, costs associated with low back pain and adverse events. All participants will be followed for a minimum of 12 months. Analysis will follow the intention-to-treat principle. Cox regression is planned to assess the effects for the outcomes of time to activity-limiting, minimal and care-seeking recurrence. Hazard ratios and median survival times with 95% confidence intervals will be calculated. The effect of the intervention on continuous outcomes will be estimated with repeated-measure linear mixed models. An economic evaluation will be performed from the societal perspective for recurrence prevented (yes/no) and quality-adjusted life years. The proportion of adverse events between groups will be compared using Fisher's exact test. DISCUSSION: The WalkBack trial will provide evidence on the effectiveness and cost-effectiveness of a walking intervention to prevent low back pain recurrences. This statistical analysis plan provides transparency on the analysis of the trial.

trial registrationWalkBack - Effectiveness and cost-effectiveness of a progressive individualised walking and education program for the prevention of a recurrence of low back pain. ACTRN12619001134112 . Date Registered: 14/08/2019.

Indexed as

Low Back PainAdultCost-Benefit AnalysisExerciseHumansQuality of LifeWalkingLow back painPreventionRandomised-controlled trialStatistical analysis planWalking

Identifiers

PMID36927497
PMCPMC10019396
OpenAlexW4327680965

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read12
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.