Condition category
Musculoskeletal Diseases
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
24/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M.E.A.L. Kroese

ORCID ID

Contact details

University Hospital Maastricht
BZe VII - Transmurale Zorg
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3874406
mkroes@adcc.azm.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR421

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study is to care for patients with fibromyalgia more efficiently through the cooperation of the rheumatologist and the nurse specialist. Because of this, the rheumatology outpatient department can be relieved partly, which can have a positive consequence on the waiting list for patients with other rheumatologic disorders. Besides, we expect that this new way of diagnostics will have a small therapeutic effect. First, the patient can be seen two and a half months earlier. At the moment, there is a three-month waiting list for fibromyalgia patients at the rheumatology outpatient departments, but at the nurse specialist there is only a three-week waiting list. This can have a favourable effect on uncertainty and fixation of the complaints. Furthermore, the nurse specialist has probably more time and by this more attention for the support of this patient group.

Ethics approval

Received from local medical ethics committee

Study design

Randomised single blind active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Fibromyalgia

Intervention

1. A fast-tracked diagnosis, in which the nurse specialist gathers data by a prestructured anamnesis, and sets in screening diagnostics. At the end of the visit, the rheumatologist is involved. He is able to accept or reject the diagnosis in a shorter time on the basis of the available data.
2. Regular visit at the rheumatology outpatient clinic

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Social participation
2. Medical consumption
3. Quality of life

Secondary outcome measures

1. Pain
2. Anxiety
3. Catastrophying
4. Fatigue
5. Disability
6. Self-efficacy

Overall trial start date

24/11/2003

Overall trial end date

01/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Suspicion fibromyalgia
2. First visit to rheumatology outpatient clinic
3. Age 18-65
4. Be able to understand Dutch language

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

188

Participant exclusion criteria

1. Comorbidity locomotor apparatus
2. Involved in an appeal concerning disability payment

Recruitment start date

24/11/2003

Recruitment end date

01/11/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Hospital Maastricht
Maastricht
6202 AZ
Netherlands

Sponsor information

Organisation

Academic Hospital Maastricht (AZM) (The Netherlands)

Sponsor details

P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3876543
info@azm.nl

Sponsor type

Not defined

Website

Funders

Funder type

Other

Funder name

Care Funds (Zorgvernieuwingsgelden) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18759317
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21459951

Publication citations

  1. Results

    Kroese ME, Schulpen GJ, Bessems MC, Severens JL, Nijhuis FJ, Geusens PP, Landewé RB, Substitution of specialized rheumatology nurses for rheumatologists in the diagnostic process of fibromyalgia: a randomized controlled trial., Arthritis Rheum., 2008, 59, 9, 1299-1305, doi: 10.1002/art.24018.

  2. Results

    Kroese ME, Severens JL, Schulpen GJ, Bessems MC, Nijhuis FJ, Landewé RB, Specialized rheumatology nurse substitutes for rheumatologists in the diagnostic process of fibromyalgia: a cost-consequence analysis and a randomized controlled trial., J. Rheumatol., 2011, 38, 7, 1413-1422, doi: 10.3899/jrheum.100753.

Additional files

Editorial Notes