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ISRCTN
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ISRCTN86684957
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ClinicalTrials.gov identifier
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Public title
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The effect of education about pain on illness perceptions in patients with fibromyalgia: a randomised clinical trial with a six-month follow up
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Ethics approval
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Ethics approval received from the Medical Ethical Committee of University Hospital Antwerpen (Belgium) in October 2007.
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Study design
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Multicentre randomised single-blind controlled trial
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Countries of recruitment
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Belgium, The Netherlands
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Disease/condition/study domain
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Fibromyalgia syndrome, chronic pain, patient education
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Participants - inclusion criteria
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Patients with fibromyalgia according to the diagnostic criteria by the American College of Rheumatology, both men and women.
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Participants - exclusion criteria
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1. Age under 18 or over 65 years
2. Non-Dutch speaking
3. Pregnant during study period
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Anticipated start date
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20/10/2007
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Anticipated end date
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30/06/2008
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Status of trial
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Completed
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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200 participants in total, 100 in the intervention group (information about sensitisation) and 100 in the control group (information about relaxation)
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Interventions
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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
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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1. Hanze University Groningen (The Netherlands)
2. University of Antwerp (Belgium)
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Trial website
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Publications
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Contact name
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Mrs
Miriam
van Ittersum
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Address
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Eyssoniusplein 18
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City/town
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Groningen
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Zip/Postcode
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9714 CE
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Country
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Netherlands
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Sponsor
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University of Antwerp (Belgium)
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Address
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c/o Jo Nijs
Keizerstraat 15
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City/town
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Antwerpen
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Zip/Postcode
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2000
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Country
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Belgium
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Sponsor website:
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http://www.ua.ac.be/
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Date applied
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20/03/2008
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Last edited
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30/04/2008
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Date ISRCTN assigned
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30/04/2008
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