Evidence map›Paper›PMID 31427344›Full record

ArticleBMJ open2019

RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial.

Peter Kent, P O'Sullivan, Anne Smith, Terry Haines, Amity Campbell, Alison H McGregor, Jan Hartvigsen, Kieran O'Sullivan, Alistair Vickery, J P Caneiro and 4 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.1field-weighted citation impact, top 14% 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

7 citing papers in PubMed, 37 citations in OpenAlex.

  1. Trial
  2. Observational
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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

14 authors at 8 institutions in 4 countries.

Peter KentSchool of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia peter.kent@curtin.edu.au.ORCID 0000-0002-2429-9233
P O'SullivanSchool of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.
Anne SmithSchool of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.
Terry HainesFaculty of Medicine, Nursing and Health Science, Monash University, Melbourne, Victoria, Australia.
Amity CampbellSchool of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.
Alison H McGregorDepartment of Surgery and Cancer, Imperial College London, London, UK.
Jan HartvigsenDepartment of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.
Kieran O'SullivanSports Spine Centre, Aspetar Qatar Orthopaedic and Sports Medicine Hospital, Doha, Qatar.
Alistair VickeryGeneral Practice, The University of Western Australia, Crawley, Western Australia, Australia.
J P CaneiroSchool of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.
Robert SchützeSchool of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.
Robert A LairdSuperspine, Melbourne, Victoria, Australia.
Stephanie AttwellDepartment of Health Professions, Macquarie University, Sydney, New South Wales, Australia.
Mark HancockDepartment of Health Professions, Macquarie University, Sydney, New South Wales, Australia.
Curtin University · AUMacquarie University · AUUniversity of Southern Denmark · DKImperial College London · GBMind Australia · AUMonash University · AUQatar Orthopaedic and Sports Medicine Hospital · QAThe University of Western Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLow back pain (LBP) is the leading cause of disability globally and its costs exceed those of cancer and diabetes combined. Recent evidence suggests that individualised cognitive and movement rehabilitation combined with lifestyle advice (cognitive functional therapy (CFT)) may produce larger and more sustained effects than traditional approaches, and movement sensor biofeedback may enhance outcomes. Therefore, this three-arm randomised controlled trial (RCT) aims to compare the clinical effectiveness and economic efficiency of individualised CFT delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling LBP. METHODS AND ANALYSIS: Pragmatic, three-arm, randomised, parallel group, superiority RCT comparing usual care (n=164) with CFT (n=164) and CFT-plus-movement-sensor-biofeedback (n=164). Inclusion criteria include: adults with a current episode of LBP >3 months; sought primary care ≥6 weeks ago for this episode of LBP; average LBP intensity of ≥4 (0-10 scale); at least moderate pain-related interference with work or daily activities. The CFT-only and CFT-plus-movement-sensor-biofeedback participants will receive seven treatment sessions over 12 weeks plus a 'booster' session at 26 weeks. All participants will be assessed at baseline, 3, 6, 13, 26, 40 and 52 weeks. The primary outcome is pain-related physical activity limitation (Roland Morris Disability Questionnaire). Linear mixed models will be used to assess the effect of treatment on physical activity limitation across all time points, with the primary comparison being a formal test of adjusted mean differences between groups at 13 weeks. For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L . ETHICS AND DISSEMINATION: Approved by Curtin University Human Research Ethics Committee (HRE2018-0062, 6 Feb 2018). Study findings will be disseminated through publication in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12618001396213).

Indexed as

MovementTransducersAustraliaBiofeedback, PsychologyChronic PainCognitive Behavioral TherapyCost-Benefit AnalysisDisability EvaluationEquivalence Trials as TopicExerciseHumansLow Back PainMulticenter Studies as TopicPain MeasurementPhysical Therapy ModalitiesPragmatic Clinical Trials as Topicclinical trial protocollow back painrehabilitationwearable electronic devices

Identifiers

PMID31427344
PMCPMC6701662
OpenAlexW2969670848

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.