Evidence map›Paper›PMID 33649056›Full record

ArticleBMJ open2021

Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial.

María Reina-Bueno, María Del Carmen Vázquez-Bautista, Inmaculada C Palomo-Toucedo, Gabriel Domínguez-Maldonado, José Manuel Castillo-López, Javier Ramos-Ortega, Pedro V Munuera-Martínez

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04098055 (Effectiveness of Custom-made Foot Orthoses in Patients With Systemic Lupus Erythematous), 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.

NCT04098055 nacompletednot on this map

Effectiveness of Custom-made Foot Orthoses in Patients With Systemic Lupus Erythematous

TypeinterventionalSponsorUniversity of SevilleRan2019 to 2022Enrolled40ConditionsLupus Erythematosus, Systemic, Foot Orthoses, Musculoskeletal PainArmsCustom-Made Foot Orthoses, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

7 authors.

María Reina-BuenoDepartment of Podiatry, University of Seville, Seville, Spain mreina1@us.es.ORCID http://orcid.org/0000-0001-9316-8942
María Del Carmen Vázquez-BautistaDepartment of Podiatry, University of Seville, Seville, Spain.
Inmaculada C Palomo-ToucedoDepartment of Podiatry, University of Seville, Seville, Spain.
Gabriel Domínguez-MaldonadoDepartment of Podiatry, University of Seville, Seville, Spain.
José Manuel Castillo-LópezDepartment of Podiatry, University of Seville, Seville, Spain.
Javier Ramos-OrtegaDepartment of Podiatry, University of Seville, Seville, Spain.
Pedro V Munuera-MartínezDepartment of Podiatry, University of Seville, Seville, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE. METHODS AND ANALYSIS: A randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life. ETHICS AND DISSEMINATION: The study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect. TRIAL REGISTARTION NUMBER: Clinicaltrials.gov identifier NCT04098055.

Indexed as

Foot OrthosesLupus Erythematosus, SystemicHumansPainPain MeasurementQuality of LifeRandomized Controlled Trials as TopicTreatment Outcomefoot & anklemusculoskeletal disorderspain managementrheumatology

Identifiers

PMID33649056
PMCPMC8098959

What OpenQuestion holds

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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.