Plain English Summary
Background and study aims
Fibromyalgia (FM) is a common long-term condition, which causes widespread muscle and joint pain all over the body. The exact cause of FM is unknown, but it is thought that a variety of physical, mental and emotional factors are responsible. Current treatments for FM typically involve a combination of pain killers, talking therapies and lifestyle changes. In addition, exercise has also been found to be an effective treatment, including helping to reduce pain. The aim of this study is to find out whether a multi-component rehabilitation programme can help to improve FM patients overall wellbeing, reduce their symptoms of pain, fatigue and sleep disturbances, and increase their physical activity and work ability.
Who can participate?
Adults aged between 20 and 50 who have fibromyalgia.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in a rehabilitation program in their community. This involves a 10 sessions of a mindfulness training programme called the Vitality Training Programme, VTP (which helps people to become more aware and accepting of their feelings and bodily sensations) over four months, followed by eight weeks of individually tailored physical activity counselling provided by a physiotherapist at a Healthy Living Centre. Those in the second group continue to receive treatment as usual for the duration of the study, but are given the chance to take part in the rehabilitation programme once the study is over. At the start of the study, after the VTP is complete (four months) and then after 12 months, participants in both groups complete a range of questionnaires in order to find out if their overall wellbeing, pain symptoms, sleep and ability to work and take part in physical activity have improved.
What are the possible benefits and risks of participating?
Participants who take part in the rehabilitation programme may benefit from improvements to their overall wellbeing, pain symptoms, sleep and ability to work and take part in physical activity. There are no notable risks involved with participating.
Where is the study run from?
The study is run by the National Advisory Unit on Rehabilitation in Rheumatology and takes place in two districts in the City of Oslo and six other municipalities in South-Eastern Norway (Norway)
When is the study starting and how long is it expected to run for?
March 2016 to May 2020
Who is funding the study?
South-Eastern Norway Regional Health Authority (Norway)
Who is the main contact?
Dr Heidi A. Zangi
heidi.zangi@diakonsyk.no
Trial website
Contact information
Type
Scientific
Primary contact
Dr Heidi A. Zangi
ORCID ID
http://orcid.org/0000-0001-6882-221X
Contact details
National Advisory Unit on Rehabilitation in Rheumatology
PO Box 23 Vinderen
Oslo
0319
Norway
+47 (0)93054517
heidi.zangi@diakonsyk.no
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2016015
Study information
Scientific title
Evaluation of a multicomponent rehabilitation program for patients with fibromyalgia in primary health care compared to treatment as usual combined with a short patient education program: Effects on patient global impression of change, disease related symptoms, physical activity and work ability
Acronym
Study hypothesis
The integrated care model will improve fibromyalgia patients’ overall wellbeing, pain, fatigue, sleep disturbances, physical activity and work ability at one-year follow-up compared to patients receiving ‘treatment as usual’.
Ethics approval
Regional Committees for Medical and Health Research Ethics, 04/02/2016, ref: 2015/2447
Study design
Multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, only available in Norwegian
Condition
Fibromyalgia/widespread musculoskeletal pain
Intervention
Participants will be randomised one of two groups:
Intervention group: Participants take part in a multicomponent rehabilitation programme in their home municipality. The programme comprises a 10-session mindfulness-based Vitality Training Programme (VTP) followed by 8 weeks tailored physical exercise supervised by a physiotherapist at a Healthy Life Center.
Control group: Participants will receive treatment as usual in primary care, i.e. GP consultations and any physical activity as usual. They will be offered the VTP after completion of the last data collection, i.e. one year after inclusion.
Participants in both groups are followed up at 4 months (end of VTP) and 12 months post-randomisation.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Patient global impression of change (PGIC) measured by a 7-point self-reported Likert scale ranging from 1 (“I feel very much worse”) through 4 (“no change”) to 7 (“I feel very much better”) one year after inclusion. Scores of 6 and 7 are considered clinically relevant improvement. The primary outcome will be measured after completion of the VTP (4 months) and at 12 months follow-up.
Secondary outcome measures
All outcomes will be measured at baseline (before randomisation), at 4 months and 12 months:
1. Pain, measured by Numeric Rating Scale (NRS, 0-10)
2. Fatigue, measured by Numeric Rating Scale (NRS, 0-10)
3. Sleep quality, measured by Numeric Rating Scale (NRS, 0-10)
4. Psychological distress, measured by General Health Questionnaire-12 (GHQ-12)
5. Physical activity, measured by 4 questions from the Norwegian HUNT-study
6. Work ability, measured by the Work Productivity and Activity Impairment Questionnaire (WPAI)
Overall trial start date
01/03/2016
Overall trial end date
31/05/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Rheumatologist confirmed diagnosis of fibromyalgia according to the American College of Rheumatology 2011 criteria
2. Aged between 20 and 50
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140
Participant exclusion criteria
1. Comorbid inflammatory rheumatic disease
2. Serious psychiatric disorder
3. Other disease impeding physical activity
4. Not at all been working during the last two years because of disease
5. Not able to understand and speak Norwegian
Recruitment start date
01/11/2016
Recruitment end date
31/08/2018
Locations
Countries of recruitment
Norway
Trial participating centre
National Advisory Unit on Rehabilitation in Rheumatology
Dept. of Rheumatology
Diakonhjemmet Hospital
PO Box 23 Vinderen
Oslo
0319
Norway
Trial participating centre
Eidsvoll Municipality
Rådhusgata 1
Eidsvoll
2080
Norway
Trial participating centre
Hurdal Municipality
Minneåsvegen 3
Hurdal
2090
Norway
Trial participating centre
Gjerdrum Municipality
Gjerivegen 1
Gjerdrum
2022
Norway
Trial participating centre
Nannestad Municipality
Teiealleen 31
Nannestad
2030
Norway
Trial participating centre
Nes Municipality
Rådhusgata 2
Årnes
2150
Norway
Trial participating centre
Ullensaker Municipality
Furusethgt. 12
Jessheim
2050
Norway
Trial participating centre
Frogner District
Sommerrogata 1
Oslo
0201
Norway
Trial participating centre
Ullern District
Hoffsveien 48
0377
0377
Norway
Sponsor information
Organisation
National Advisory Unit on Rehabilitation in Rheumatology
Sponsor details
PO Box 23 Vinderen
Oslo
0319
Norway
+47 (0)22451500
postmottak@diakonsyk.no
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
South-Eastern Norway Regional Health Authority
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results from the study will be published in a high-impact peer reviewed journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Heidi A. Zangi (heidi.zangi@diakonsyk.no).
Intention to publish date
01/06/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29866731