Evidence map›Paper›PMID 29866731›Full record

ArticleBMJ open2018

Effects of a community-based multicomponent rehabilitation programme for patients with fibromyalgia: protocol for a randomised controlled trial.

Trond Haugmark, Kåre Birger Hagen, Sella Aarrestad Provan, Elisebeth Bærheim, Heidi A Zangi

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing 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.

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

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

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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

5 authors.

Trond HaugmarkDepartment of Rheumatology, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Kåre Birger HagenDepartment of Rheumatology, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Sella Aarrestad ProvanDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Elisebeth BærheimNorwegian League Against Rheumatism, Oslo, Norway.
Heidi A ZangiDepartment of Rheumatology, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPeople with fibromyalgia (FM) suffer from symptoms such as widespread pain, non-refreshing sleep, fatigue and reduced quality of life. Effects of pharmacological treatment are questionable and non-pharmacological treatments are recommended as first-line therapy. To date the majority of patients with FM in Norway are not offered any targeted treatment. The aim of this randomised controlled trial is to investigate the effects of a community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling. MATERIALS AND

methodsGeneral practitioners refer potential participants to a rheumatologist in specialist healthcare for diagnostic clarification and assessment of comorbidities. Inclusion criteria are widespread pain/FM ≥3 months, age 20-50 and work participation (minimum part-time) within the last 2 years. The intervention group attends the VTP comprising 10 weekly 4 hour group sessions plus a booster session after 6 months. Thereafter, they receive 12 weeks of individually tailored physical exercise counselled by physiotherapists at community-based Healthy Life Centers. The control group follows treatment as usual. The primary outcome is Patient Global Impression of Change. Secondary outcomes include self-reported pain, fatigue and sleep quality, psychological distress, mindfulness, health-related quality of life, physical activity, work ability and exercise beliefs and habits. To achieve a power of 80% and allow for 10% dropout, 70 participants are needed in each arm. All analyses will be conducted on intention-to-treat bases and measured as differences between groups at 12 months follow-up. ETHICS AND DISSEMINATION: The study is approved and granted by the Norwegian South-Eastern Regional Health Authority (reference 2016015). Ethics approval was obtained from Regional Committee for Medical and Health Research Ethics (reference 2015/2447/REK sør-øst A). Results will be submitted to appropriate journals and presented in relevant conferences and social media.

trial registrationISRCTN 96836577.

Indexed as

Adaptation, PsychologicalAdultExercise TherapyFemaleFibromyalgiaHumansLogistic ModelsMaleMiddle AgedMindfulnessNorwayPatient Education as TopicProspective StudiesQuality of LifeRandomized Controlled Trials as TopicYoung Adultfibromyalgiahealth promotionmindfulness-and acceptance based interventionsphysical activityprimary health carerehabilitation

Identifiers

PMID29866731
PMCPMC5988178

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.