Improved management of patients with fibromyalgia: Implementation and evaluation of an integrated care model
| ISRCTN | ISRCTN96836577 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96836577 |
| Secondary identifying numbers | 2016015 |
- Submission date
- 12/07/2016
- Registration date
- 12/07/2016
- Last edited
- 10/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
National Advisory Unit on Rehabilitation in Rheumatology
PO Box 23 Vinderen
Oslo
0319
Norway
 ORCID ID |
0000-0001-6882-221X |
|---|---|
| Phone | +47 (0)93054517 |
| heidi.zangi@diakonsyk.no |
Study information
| Study design | Multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, only available in Norwegian |
| 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 |
| Study objectives | 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(s) | Regional Committees for Medical and Health Research Ethics, 04/02/2016, ref: 2015/2447 |
| Health condition(s) or problem(s) studied | 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 |
| 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) Added 04/05/2021: 7. Tendency to be mindful measured using the Five Facet Mindfulness Questionnaire (FFMQ) at baseline (before randomisation), at 4 months and 12 months 8. Motivation and barriers to physical activity measured using the Exercise Beliefs and Exercise Habits questionnaire at baseline (before randomisation), at 4 months and 12 months 9. Health-related quality of life measured using the EuroQol (EQ-5D-5L) at baseline (before randomisation), at 4 months and 12 months |
| Overall study start date | 01/03/2016 |
| Completion date | 31/05/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 140 |
| Total final enrolment | 170 |
| Key inclusion criteria | 1. Rheumatologist confirmed diagnosis of fibromyalgia according to the American College of Rheumatology 2011 criteria 2. Aged between 20 and 50 |
| Key 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 |
| Date of first enrolment | 01/11/2016 |
| Date of final enrolment | 31/08/2018 |
Locations
Countries of recruitment
- Norway
Study participating centres
Diakonhjemmet Hospital
PO Box 23 Vinderen
Oslo
0319
Norway
Eidsvoll
2080
Norway
Hurdal
2090
Norway
Gjerdrum
2022
Norway
Nannestad
2030
Norway
Årnes
2150
Norway
Jessheim
2050
Norway
Oslo
0201
Norway
0377
0377
Norway
Sponsor information
Hospital/treatment centre
PO Box 23 Vinderen
Oslo
0319
Norway
| Phone | +47 (0)22451500 |
|---|---|
| postmottak@diakonsyk.no | |
| Website | http://diakonhjemmetsykehus.no |
"ROR" |
https://ror.org/02jvh3a15 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results from the study will be published in a high-impact peer reviewed journal. |
| IPD sharing plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 04/06/2018 | Yes | No | |
| Results article | 29/06/2021 | 01/07/2021 | Yes | No | |
| Results article | 07/01/2025 | 10/01/2025 | Yes | No |
Editorial Notes
10/01/2025: Publication reference added.
01/07/2021: Publication reference added.
04/05/2021: The following changes were made to the trial record:
1. The secondary outcome measures were updated.
2. Total final enrolment added.
3. The intention to publish date was changed from 31/12/2020 to 31/12/2021.
08/06/2020: The intention to publish date was changed from 01/06/2020 to 31/12/2020.
21/09/2018: The recruitment end date was updated from 01/12/2018 to 31/08/2018.
06/06/2018: Publication reference added.
06/07/2017: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/09/2016 to 01/11/2016.
2. The recruitment end date was changed from 31/12/2017 to 01/12/2018.
