Evidence map›Paper›PMID 34551809›Full record

Trial reportTrials2021

Effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain: statistical analysis plan for a randomised controlled trial.

Emma Robson, Steven J Kamper, Alix Hall, Hopin Lee, Simon Davidson, Priscilla Viana da Silva, Connor Gleadhill, Christopher M Williams, HeLP Trial Working Group

Registry-linked trialAbstract readPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07173335 (Comparison of In-person and Virtual Delivery of Healthy Lifestyle Focused Care for People With Chronic Musculoskeletal Conditions Living in Rural Areas), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT07173335 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

Comparison of In-person and Virtual Delivery of Healthy Lifestyle Focused Care for People With Chronic Musculoskeletal Conditions Living in Rural Areas: a Non-interiority Randomised Trial.

TypeinterventionalSponsorUniversity of SydneyRan2025 to 2028Enrolled354ConditionsMusculoskeletal Pain, Osteoarthritis, Low Back PainArmsIn-person physiotherapist led integrated healthy lifestyle and pain care, Virtual multidisciplinary integrated healthy lifestyle and pain care
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
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

9 authors.

Emma RobsonSchool of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.
Steven J KamperSchool of Health Sciences, University of Sydney, Camperdown, NSW, Australia.
Alix HallSchool of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.
Hopin LeeSchool of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.
Simon DavidsonSchool of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.
Priscilla Viana da SilvaSchool of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.
Connor GleadhillSchool of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.
Christopher M WilliamsSchool of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia. christopher.m.williams@newcastle.edu.au.ORCID http://orcid.org/0000-0001-8896-0978
HeLP Trial Working Group

Funding

National Health and Medical Research Council Australia APP1100992
6 · The paper itself

Abstract

backgroundThis paper describes the statistical analysis plan for a randomised controlled trial of a Healthy Lifestyle Program (HeLP) for low back pain targeting multiple health risks and behaviours, weight, physical activity, diet and smoking, to improve disability. We describe the methods for the main analyses and economic analysis of the trial. METHODS AND

designThe trial is a two-arm pragmatic randomised controlled trial comparing the effect of the HeLP intervention to usual care on low back pain disability at 26 weeks. A total of 346 adults with low back pain were recruited from the Newcastle and Hunter region between September 2017 and November 2019 and randomised to either HeLP or usual care. HeLP is a 6-month intervention with participant outcomes measured at weeks 6, 12, 26 and 52 post randomisation. This statistical analysis plan describes data integrity, handling and preparation of data for analyses and methods for analyses. The primary endpoint for the trial is disability at 26 weeks using the 24-item self-report Roland Morris Disability Questionnaire. The primary analysis will follow the intention-to-treat principle using linear mixed regression models. DISCUSSION: The statistical analysis plan for this trial was produced to reduce outcome reporting bias arising from knowledge of the study findings. Any deviations will be described and justified in the final report.

trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12617001288314 . Registered on 6 September 2017.

Indexed as

Low Back PainAdultAustraliaExerciseExercise TherapyHealthy LifestyleHumansTreatment OutcomeBack painDisabilityLifestyle

Identifiers

PMID34551809
PMCPMC8459477

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Registered trials

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.