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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Eyssoniusplein 18
Groningen
9714 CE
Netherlands
Study information
| Study design | Multicentre randomised single-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 20/10/2007 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | 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) |
| 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
9714 CE
Netherlands
Sponsor information
University of Antwerp (Belgium)
University/education
University/education
c/o Jo Nijs
Keizerstraat 15
Antwerpen
2000
Belgium
| Website | http://www.ua.ac.be/ |
|---|---|
"ROR" |
https://ror.org/008x57b05 |
Funders
Funder type
University/education
Hanze University Groningen (The Netherlands)
No information available
University of Antwerp (Belgium)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
