Condition category
Musculoskeletal Diseases
Date applied
12/07/2016
Date assigned
12/07/2016
Last edited
12/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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
P.O.box 23 Vinderen
Oslo
0319
Norway
+47 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 we 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 measures

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

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

01/09/2016

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Norway

Trial participating centre

National Advisory Unit on Rehabilitation in Rheumatology
Dept. of Rheumatology Diakonhjemmet Hospital P.O.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

P.O.box 23 Vinderen
Oslo
0319
Norway
+47 22451500
postmottak@diakonsyk.no

Sponsor type

Hospital/treatment centre

Website

http://diakonhjemmetsykehus.no

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.

Intention to publish date

01/06/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes