Condition category
Musculoskeletal Diseases
Date applied
20/03/2008
Date assigned
30/04/2008
Last edited
30/04/2008
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

Mrs Miriam van Ittersum

ORCID ID

Contact details

Eyssoniusplein 18
Groningen
9714 CE
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Does giving written information about pain and the sensitisation model influence illness perceptions and health status in patients with fibromyalgia?

Hypothesis:
Educating patients about pain physiology is effective in changing patients' negative and catastrophising perceptions about their pain and possibly has an indirect de-sensitising effect on the central nervous system.

Ethics approval

Ethics approval received from the Medical Ethical Committee of University Hospital Antwerpen (Belgium) in October 2007.

Study design

Multicentre randomised single-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

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

Condition

Fibromyalgia syndrome, chronic pain, patient education

Intervention

Participants in the intervention group receive written information about pain (aetiology, physiology) and central sensitisation, either by email or postal. After two weeks every participant gets a phone call from one of the investigators to ask if the participant received and read the information, to motivate to do so when necessary and to give the participant the possibility to ask questions about the written information. Besides this phone call, every participant can ask questions to the investigators (electronic or by post) about interpretation of the written information and about how to apply this in daily living, with a maximum of two times of contacting the investigators. Patients get a fixed number of weeks (six) to read and absorb the information, to ask questions about it and to incorporate it in their daily lives.

Participants in the control group receive written information about the possible effects of relaxation exercise and education about how to perform such exercises. The procedures for participants in the control group are exactly the same as for those in the intervention group (one phone call, maximum of two times asking questions, six weeks to read and absorb the information and to ask questions).

Measures:
1. Fibromyalgia Impact Questionnaire (FIQ)
2. Pain Catastrophising Scale (PCS)
3. Revised Illness Perception Questionnaire (IPQ-R)

The intervention starts after three weeks and lasts for six weeks.

Joint sponsor/affiliation:
University of Applied Sciences Groningen (The Netherlands)
c/o Miriam van Ittersum
Eyssoniusplein 18
9714 CE Groningen
The Netherlands

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. The 'rumination' subscale of the PCS
2. The 'consequences' and the 'psychological attributions' subscales of the IPQ-R

All outcomes will be measured at the same times: at the start of the study, after three weeks, six weeks, and six months.

Secondary outcome measures

1. The FIQ total score
2. The 'magnification' and 'helplessness' subscales of the PCS
3. The 'identity, 'timeline', 'personal control', 'treatment control', 'illness coherence', 'timeline cyclical', 'emotional representations', 'risk factor attribution', 'immune attribution', 'chance attribution' and 'fibromyalgia specific attribution' subscales of the IPQ-R

All outcomes will be measured at the same times: at the start of the study, after three weeks, six weeks, and six months.

Overall trial start date

20/10/2007

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with fibromyalgia according to the diagnostic criteria by the American College of Rheumatology, both men and women.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 participants in total, 100 in the intervention group (information about sensitisation) and 100 in the control group (information about relaxation)

Participant exclusion criteria

1. Age under 18 or over 65 years
2. Non-Dutch speaking
3. Pregnant during study period

Recruitment start date

20/10/2007

Recruitment end date

30/06/2008

Locations

Countries of recruitment

Belgium, Netherlands

Trial participating centre

Eyssoniusplein 18
Groningen
9714 CE
Netherlands

Sponsor information

Organisation

University of Antwerp (Belgium)

Sponsor details

c/o Jo Nijs
Keizerstraat 15
Antwerpen
2000
Belgium

Sponsor type

University/education

Website

http://www.ua.ac.be/

Funders

Funder type

University/education

Funder name

Hanze University Groningen (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Antwerp (Belgium)

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

Publication citations

Additional files

Editorial Notes