Evidence map›Paper›PMID 31963773›Full record

ArticleInternational journal of environmental research and public health2020

Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): Study Protocol of a Randomized Controlled Trial.

Mayte Serrat, Juan P Sanabria-Mazo, Elna García-Troiteiro, Anna Fontcuberta, Corel Mateo-Canedo, Míriam Almirall, Albert Feliu-Soler, Jorge Luis Méndez-Ulrich, Antoni Sanz, Juan V Luciano

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in International journal of environmental research and public health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04855851 (Effectiveness of Pain Neuroscience Education and Strength Training Program in Patients With Fibromyalgia), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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.

NCT04855851 nacompletednot on this mapstarted 2022, after this paper: background citation

Effectiveness of Pain Neuroscience Education and Strength Training Program in Patients With Fibromyalgia

TypeinterventionalSponsorManuel Rebollo SalasRan2022 to 2025Enrolled60ConditionsFibromyalgiaArmsPAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING, USUAL CARE
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. 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

10 authors.

Mayte SerratUnitat d'Expertesa en Síndromes de Sensibilització Central, Hospital de la Vall d'Hebron, 08035 Barcelona, Spain.ORCID 0000-0002-5591-9407
Juan P Sanabria-MazoResearch Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain.ORCID 0000-0003-1688-435X
Elna García-TroiteiroResearch Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain.
Anna FontcubertaResearch Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain.
Corel Mateo-CanedoResearch Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain.
Míriam AlmirallUnitat d'Expertesa en Síndromes de Sensibilització Central, Hospital de la Vall d'Hebron, 08035 Barcelona, Spain.
Albert Feliu-SolerResearch Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain.ORCID 0000-0003-2810-7670
Jorge Luis Méndez-UlrichResearch Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain.ORCID 0000-0001-9718-0607
Antoni SanzResearch Group on Stress and Health, Faculty of Psychology, Universitat Autònoma de Barcelona, 08193 Cerdanyola del Vallès, Spain.ORCID 0000-0002-7952-4477
Juan V LucianoInstitut de Recerca Sant Joan de Déu, 08950 Esplugues de Llobregat, Spain.ORCID 0000-0003-0750-1599

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The study protocol of a prospective and randomized controlled trial for the assessment of the efficacy of nature activity therapy for people with Fibromyalgia (NAT-FM) is described. The primary outcome is the mean change from baseline in the Revised Fibromyalgia Impact Questionnaire (FIQR) score at post-treatment (12 weeks) and at 9 months of follow-up, and secondary outcomes are changes in the positive affect, negative affect, pain, fatigue, self-efficacy, catastrophising, and emotional regulation. A total of 160 patients with fibromyalgia will be divided into two arms: treatment-as-usual (TAU) and NAT-FM+TAU. Pre, during, post, +6, and +9 months assessments will be carried out, as well as an ecological momentary assessment (EMA) of intrasession and intersessions. Results will be subjected to a mixed group (NAT-FM+TAU vs. TAU) × phase (pre, post, +6 months, +9 months) general linear model. EMA intrasession measurements will be subjected to a 2 (pre vs. post) × 5 (type of activity) mixed-effects ANOVA. EMA between-session measurements obtained from both arms of the study will be analysed on both a time-domain and frequency-domain basis. Effect sizes and number needed to treat (NNT) will be computed. A mediation/moderation analysis will be conducted.

Indexed as

Psychosocial Support SystemsExercise TherapyFibromyalgiaHumansPain ManagementPatient Education as TopicProspective StudiesRandomized Controlled Trials as TopicRelaxation TherapySpaincognitive behavioural therapyecological momentary assessmentexercise therapyfibromyalgiamulticomponent treatmentnature exposurepain neuroscience educationrandomized controlled trialstudy protocol

Identifiers

PMID31963773
PMCPMC7013723

What OpenQuestion holds

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LicenceCC BY
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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.