Evidence map›Paper›PMID 32162497›Full record

Trial reportBrain and behavior2020

A twelve-week, four-arm, randomized, double-blind, placebo-controlled, phase 2 prospective clinical trial to evaluate the efficacy and safety of an anthroposophic multimodal treatment on chronic pain in outpatients with postpolio syndrome.

Ricardo Ghelman, Ivete Y Akiyama, Valeria T de Souza, Jussara Falcão, Vera Orgolini, Jorge K Hosomi, Abrahão A J Quadros, Acary S B Oliveira

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Brain and behavior, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04387864 (The Effect of Adding Whole-Body Vibration Exercises to Home Exercise Program on Muscle Strength in Patients With Postpolio Syndrome), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 38% 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.

NCT04387864 nacompletednot on this map

The Effect of Adding Whole-Body Vibration Exercises to Home Exercise Program on Muscle Strength in Patients With Postpolio Syndrome

TypeinterventionalSponsorKoç UniversityRan2015 to 2016Enrolled14ConditionsPostpolio SyndromeArmsWhole-body Vibration Device
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
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

8 authors at 2 institutions in 1 country.

Ricardo GhelmanDepartment of Neurology, Universidade Federal de Sao Paulo, São Paulo, Brazil.ORCID 0000-0002-6700-6488
Ivete Y AkiyamaDepartment of Neurology, Universidade Federal de Sao Paulo, São Paulo, Brazil.
Valeria T de SouzaDepartment of Neurology, Universidade Federal de Sao Paulo, São Paulo, Brazil.
Jussara FalcãoDepartment of Neurology, Universidade Federal de Sao Paulo, São Paulo, Brazil.
Vera OrgoliniDepartment of Neurology, Universidade Federal de Sao Paulo, São Paulo, Brazil.
Jorge K HosomiDepartment of Obstetrics, Universidade Federal de Sao Paulo, São Paulo, Brazil.
Abrahão A J QuadrosDepartment of Neurology, Universidade Federal de Sao Paulo, São Paulo, Brazil.
Acary S B OliveiraDepartment of Neurology, Universidade Federal de Sao Paulo, São Paulo, Brazil.
Universidade Federal de São Paulo · BRHospital Universitário da Universidade de São Paulo · BR

Funding

Coordination for the Improvement of Higher Education Personnel 19826Department of Science and Technology of the Secretariat of Science, Technology and Inputs of the Ministry of Health of BrazilFoundation of the Ministry of Education/BrazilNational Council for Scientific and Technological Development 401309/2013-4
6 · The paper itself

Abstract

introductionChronic pain and fatigue are the main symptoms of postpoliomyelitis syndrome (PPS). This study aimed to evaluate the efficacy and safety of an anthroposophic multimodal treatment for chronic pain in PPS outpatients.

methodsA twelve-week, four-arm, randomized, double-blind, placebo-controlled, phase 2 prospective clinical trial was designed to compare four groups (n = 48): groups A and B received daily active experimental transdermal gel (ETG) or placebo gel (PTG), respectively; groups C and D received weekly external therapies, art therapies, and neurofunctional reorganization, plus either daily ETG or PTG, respectively. The pain symptoms were evaluated through a visual analogue scale (VAS), the McGill questionnaire, and thermography. Quality of life and resilience were evaluated by the WHOQOL-BREF and Antonovsky sense of coherence questionnaires applied at baseline and after the interventions.

resultsNo related adverse events occurred, and 10% of the patients reports dysphagia improvement. In the groups C and D, pain reduction was statistically significant in both the placebo group (p = .02, d = 1.315) and in the ETG (p = .005, d = 2.035). However, following the week-to-week evolution of pain with the concomitant use of the ETG, this significant pain reduction occurred earlier from the 4th week and continued to decrease (p = .016, d = 1.369). In the group that received the complete multimodal treatment, the greatest significant benefit in increasing quality of life occurred in the physical domain and elevation in resilience with an emphasis on meaning and comprehension domains.

conclusionsThe anthroposophic multimodal treatment group presented both safety and efficacy as an analgesic in the groups that received the nonpharmacological therapies, much earlier when associated with the ETG. The multimodal approach corresponded to the pattern of better efficacy for both pain reduction and improvement in quality of life and resilience.

Indexed as

Art TherapyAdultAnalgesicsChronic PainCombined Modality TherapyDouble-Blind MethodFemaleHumansMaleMateria MedicaMiddle AgedOutpatientsPain MeasurementPostpoliomyelitis SyndromeProspective StudiesQuality of LifeAnalgesicsMateria Medicaanthroposophic medicinemotor systemneurodegenerative diseasespainpostpolio syndrome

Identifiers

PMID32162497
PMCPMC7177555
OpenAlexW3010795670

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.