Evidence map›Paper›PMID 30349585›Full record

ArticleJournal of foot and ankle research2018

Prefabricated foot orthoses compared to a placebo intervention for the treatment of chronic nonspecific low back pain: a study protocol for a randomised controlled trial.

Sean Sadler, Martin Spink, Samuel Cassidy, Vivienne Chuter

Open access · goldAbstract read
In one paragraph

Article in Journal of foot and ankle research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 31% 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

4 citing papers in PubMed, 12 citations in OpenAlex.

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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

4 authors at 1 institution in 1 country.

Sean SadlerDiscipline of Podiatry, University of Newcastle, 10 Chittaway Road, Ourimbah, NSW 2258 Australia.ORCID 0000-0002-7546-5836
Martin SpinkDiscipline of Podiatry, University of Newcastle, 10 Chittaway Road, Ourimbah, NSW 2258 Australia.
Samuel CassidyDiscipline of Podiatry, University of Newcastle, 10 Chittaway Road, Ourimbah, NSW 2258 Australia.
Vivienne ChuterDiscipline of Podiatry, University of Newcastle, 10 Chittaway Road, Ourimbah, NSW 2258 Australia.
Hunter Water · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrefabricated foot orthoses are used to treat chronic nonspecific low back pain, however their effectiveness and potential mechanism of action is unclear. The primary aims of the study are to investigate the effectiveness of prefabricated foot orthotic devices for reducing pain and improving function in people with chronic nonspecific low back pain over 52 weeks.

methodsThis study is a participant and assessor blinded, parallel-group, superiority randomised (1:1) controlled trial. The study will recruit 60 participants aged 18 to 65 years with chronic nonspecific low back pain. Participants will undergo randomisation to a control group (The Back Book) or an intervention group (prefabricated foot orthoses and The Back Book). The primary outcome measures will be change in pain and function from baseline to 12 (primary time point), 26, and 52 weeks. Secondary outcome measures include: gluteus medius muscle activity and transversus abdominis muscle thickness from baseline to 12 weeks, physical activity over 12, 26, and 52 weeks, and correlation between foot type and change in measures of pain and function. Number of hours per day and week that the prefabricated orthoses are worn, as well as, adverse events will be self-reported by participants. Data will be analysed using the intention-to-treat principle. DISCUSSION: This trial will primarily evaluate the effectiveness of prefabricated foot orthotic devices for reducing pain and improving function in people with chronic nonspecific low back pain over 52 weeks. It is expected that this study will provide clinicians and researchers with an understanding of the role that prefabricated foot orthoses may have in the treatment of chronic nonspecific low back pain and a potential mechanism of action, and whether foot type influences the outcome.

trial registrationACTRN12618001298202.

Indexed as

Chronic PainEquipment DesignFoot OrthosesLow Back PainRandomized Controlled Trials as TopicAdolescentAdultAgedFemaleHumansMaleMiddle AgedPain MeasurementRange of Motion, ArticularTreatment OutcomeYoung AdultChronic nonspecific low back painFoot typeGluteus mediusPrefabricated foot orthosesRandomised controlled trialTransversus abdominis

Identifiers

PMID30349585
PMCPMC6192308
OpenAlexW2896116064

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.