Identifying prognostic factors in fibromyalgia
| ISRCTN | ISRCTN43251759 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43251759 |
| Protocol serial number | n/a |
| Sponsor | Norwegian National Advisory Unit on Rehabilitation in Rheumatology |
| Funder | Norwegian National Advisory Unit on Rehabilitation in Rheumatology |
- Submission date
- 21/07/2017
- Registration date
- 06/08/2017
- Last edited
- 16/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
People with fibromyalgia (FM) are managed in both primary and secondary care, but its diagnosis and management remain a challenge for patients and healthcare professionals. Currently, there is no evidence of the outcome of treatment and rehabilitation of FM in Norway, or whether patient characteristics and content of the rehabilitation program influences patients' health outcome. Consequently, there is currently no attempt to target the rehabilitation practice to patient characteristics. The aim of this study is to examine three different aspects of rehabilitation for FM in Norway.
Who can participate?
Adults aged 18 to 70 who have FM
What does the study involve?
Participants are asked to complete a questionnaire about their current and planned rehabilitation, their general health and other information. This is completed before they receive rehabilitation, as well as six and 12 months after the end of rehabilitation.
What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.
Where is the study run from?
This study is being run by Norwegian National Advisory Unit on Rehabilitation in Rheumatology (Norway) and takes place in three regional coordination units for rehabilitation in Western, South-Eastern and Central Norway
When is the study starting and how long is it expected to run for?
April 2017 to June 2018
Who is funding the study?
Norwegian National Advisory Unit on Rehabilitation in Rheumatology (Norway)
Who is the main contact?
Professor Kåre Birger Hagen
kare.birger.hagen@fhi.no
Contact information
Public
Norwegian National Advisory Unit on Rehabilitation in Rheumatology
PO Box 23 Vinderen
Oslo
N-0319 Oslo
Norway
 ORCID ID |
0000-0003-4155-7959 |
|---|---|
| Phone | +47 22454855 |
| kare.birger.hagen@fhi.no |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multi-centre prospective observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Development and validation of a fibromyalgia rehabilitation screening tool |
| Study acronym | FiRST |
| Study objectives | The aim of this study is to examine three distinct but inter-related aspects of rehabilitation for fibromyalgia (FM) including: 1. The course of FM in the context of the nature and quality of current at Norwegian rehabilitation institutions 2. Identification of specific factors that is associated with prognosis of FM in this context 3. Development and validation of a statistical model that can predict individual risk of a future outcome for patients with FM |
| Ethics approval(s) | Norwegian Regional Committee for Medical Research Ethics (REK South-East), 22/02/2017, ref: 2016/2032 |
| Health condition(s) or problem(s) studied | Fibromyalgia |
| Intervention | When consent has been provided, a unique identifier for each participant is generated and registered in an online data collection tool. The participants receive an email or SMS with a unique link to the questionnaire, and asked to complete sections on general demographic information, current and planned treatment and rehabilitation, information about symptoms and possible prognostic factors for FM. The questionnaires are completed one to three weeks before rehabilitation, and six and 12 months after inclusion. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Patient global impression of change (PGCI) is measured using the seven point self-reported Likert scale at six and 12 months |
| Key secondary outcome measure(s) |
Work productivity and activity impairment is measured using the Work Productivity and Activity Impairment (WPAI) questionnaire at six and 12 months |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1000 |
| Total final enrolment | 986 |
| Key inclusion criteria | 1. Patients with Fibromyalgia referred to rehabilitation by their general practitioner 2. Men and women between 18 and 70 years of age admitted to the participating centre |
| Key exclusion criteria | Inability to understand and speak Norwegian. |
| Date of first enrolment | 01/04/2017 |
| Date of final enrolment | 30/09/2018 |
Locations
Countries of recruitment
- Norway
Study participating centres
N-1450 Nesoddtangen
Norway
N-5021 Bergen
Norway
N-7601 Levanger
Norway
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/03/2022 | 16/08/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/08/2022: Publication reference and total final enrolment added.
16/07/2018: The recruitment end date was changed from 30/06/2018 to 30/09/2018 and the contact email address was updated.
