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
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