The effect of education about pain on illness perceptions in patients with fibromyalgia: a randomised clinical trial with a six-month follow up

ISRCTN	ISRCTN86684957
DOI	https://doi.org/10.1186/ISRCTN86684957
Protocol serial number	N/A
Sponsor	University of Antwerp (Belgium)
Funders	Hanze University Groningen (The Netherlands), University of Antwerp (Belgium)

Submission date: 20/03/2008
Registration date: 30/04/2008
Last edited: 30/04/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Miriam van Ittersum
Scientific

Eyssoniusplein 18
Groningen
9714 CE
Netherlands

Study information

Primary study design	Interventional
Study design	Multicentre randomised single-blind controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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(s)	Ethics approval received from the Medical Ethical Committee of University Hospital Antwerpen (Belgium) in October 2007.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key inclusion criteria	Patients with fibromyalgia according to the diagnostic criteria by the American College of Rheumatology, both men and women.
Key exclusion criteria	1. Age under 18 or over 65 years 2. Non-Dutch speaking 3. Pregnant during study period
Date of first enrolment	20/10/2007
Date of final enrolment	30/06/2008

Locations

Countries of recruitment

Belgium
Netherlands

Study participating centre

Eyssoniusplein 18

Groningen
9714 CE
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes