Evidence map›Paper›PMID 32451161›Full record

Trial reportBrazilian journal of physical therapy

TOPS - a randomized controlled trial of exercise and education to prevent recurrence of low back pain: statistical analysis plan.

Giovanni E Ferreira, Chung-Wei Christine Lin, Matthew Leigh Stevens, Mark J Hancock, Jane Latimer, Trish Wisbey-Roth, Chris G Maher, TOPS trial investigators

Abstract readRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Brazilian journal of physical therapy. 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
–field-weighted citation impact
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.

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

8 authors.

Giovanni E FerreiraSydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia. Electronic address: giovanni.ferreira@sydney.edu.au.
Chung-Wei Christine LinSydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia.
Matthew Leigh StevensNational Research Centre for the Working Environment, Copenhagen, Denmark.
Mark J HancockDepartment of Health Professions, Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia.
Jane LatimerSydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia.
Trish Wisbey-RothBounce Back Active Rehabilitation Systems, Sydney, Australia.
Chris G MaherSydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia.
TOPS trial investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis a priori statistical analysis plan describes the methods of analysis for the Trial Of Prevention Strategies for low back pain (TOPS).

objectivesTOPS aimed to investigate the effectiveness and cost-effectiveness of exercise and education classes compared with a minimal intervention control in preventing recurrence of low back pain (LBP) in people who have recently recovered from an episode of LBP.

methodsTOPS is a superiority, pragmatic, parallel-group randomized controlled trial with allocation concealment, blinded outcome assessors, and intention-to-treat analysis. Participants were randomized to a physical therapist-led exercise and education program for 12 weeks or minimal intervention. The primary outcome was days to recurrence of an episode of LBP. The three key secondary outcomes were days to recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day. Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression. Hazard ratios (HRs) and median survival times with 95% confidence intervals (CI) will be calculated. The number of adverse events, including serious adverse events will be reported and the proportion of adverse events between groups will be compared using a Chi-squared test. DISCUSSION: This paper will provide a detailed description of the planned analyses for the TOPS trial.

trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12615000939594).

Indexed as

AustraliaCost-Benefit AnalysisExerciseHumansLow Back PainOutcome Assessment, Health CareTreatment OutcomeExerciseLow back painRandomized controlled trialRehabilitationSecondary prevention

Identifiers

PMID32451161
PMCPMC7352037

What OpenQuestion holds

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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.