Evidence map›Paper›PMID 34527936›Full record

ArticleArchives of rheumatology2021

A probiotic intervention on pain hypersensitivity and microbiota composition in patients with osteoarthritis pain: Study protocol for a randomized controlled trial.

Paolo Pedersini, Marco Savoldi, Pedro Berjano, Jorge Hugo Villafañe

Open access · diamondAbstract read
In one paragraph

Article in Archives of rheumatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 3 pooled it
0.7field-weighted citation impact, top 30% 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

11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 8 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 3 institutions in 1 country.

Paolo PedersiniDepartment of Clinical Research, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.ORCID 0000-0002-3239-7626
Marco SavoldiDepartment of School of Physiotherapy, University of Brescia, Brescia, Italy.
Pedro BerjanoDepartment of Spinal Surgery, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.ORCID 0000-0002-1891-3719
Jorge Hugo VillafañeDepartment of Clinical Research, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.
Don Carlo Gnocchi Foundation · ITIstituto Ortopedico Galeazzi · ITUniversity of Brescia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis study aims to examine the effects of probiotics on pain hypersensitivity at the end of a six-week intervention program in patients with osteoarthritis (OA)-related pain. PATIENTS AND

methodsThis double-blind randomized controlled clinical trial with two parallel arms will be conducted between January 2021 and July 2022. At least 30 participants (age range, 50 to 90 years) of both sexes with a diagnosis of symptomatic hip or knee (Kellgren-Lawrence scale ≥3) will be recruited in each arm (total n=60) to achieve adequate statistical power in the analyses. The intervention will be administered for six weeks followed by a four-week follow-up period. The experimental group will receive a probiotic product plus the usual medical care. The control group will receive a probiotical sham plus the usual medical care. Assessment points will be measured at baseline, end of intervention, and one-month post-intervention. The outcomes of this intervention will be a change in visual analog scale pain and the gut microbiota composition. Group by time effects will be compared using mixed-model analysis of variance.

conclusionA reduction in pain hypersensitivity in patients with knee OA-related pain could suggest an involvement of microbiota, or part of it, in chronic pain state mechanisms.

Indexed as

Microbiotaosteoarthritispainprobiotics

Identifiers

PMID34527936
PMCPMC8418770
OpenAlexW3171069325

What OpenQuestion holds

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Registered trials

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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.