Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2015-06-30
2016-02-29
Brief Summary
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The investigators propose a study with a higher dose of education of pain physiology (i.e. a higher number of educational sessions and total education time) to study if this generates a larger treatment effect in patients with fibromyalgia.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Educational program Control Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 4 first sessions: relaxation exercises 2 last sessions: talk about medical issues (drugs, nutrition, importance of sleep...)
Educational program
Patients in experimental groups will receive different educational sessions (contents and duration)
Educational program High Dose Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 6 sessions: 45 minutes of educational sessions about the neurophysiology of pain + 15 minutes of relaxation exercises
Educational program
Patients in experimental groups will receive different educational sessions (contents and duration)
Educational program Diluted Low Dose Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 6 sessions: 45 minutes of educational sessions about the neurophysiology of pain + 15 minutes of relaxation exercises
Educational program
Patients in experimental groups will receive different educational sessions (contents and duration)
Educational program Concentrated Low Dose Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 4 first sessions: relaxation exercises 2 last sessions: educational sessions about the neurophysiology of pain
Educational program
Patients in experimental groups will receive different educational sessions (contents and duration)
Interventions
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Educational program
Patients in experimental groups will receive different educational sessions (contents and duration)
Eligibility Criteria
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Inclusion Criteria
* Reported average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale based on 1 week of daily pain diaries
* On stable doses of medications for FM ≥ 4 weeks
Exclusion Criteria
* Have a planned elective surgery during the study period
* Have ongoing unresolved disability claims
* Experience symptoms of bipolar disorder, major depressive disorder, panic disorder, or psychosis
* Do not speak Spanish fluently
18 Years
65 Years
ALL
No
Sponsors
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Universidad Rey Juan Carlos
OTHER
University of Alcala
OTHER
University of Valencia
OTHER
Cardenal Herrera University
OTHER
Responsible Party
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J.J. Amer-Cuenca
Head of Department
Principal Investigators
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Juan J. Amer-Cuenca
Role: STUDY_DIRECTOR
Head of Physical Therapy Department
Locations
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Unviversidad de Alcalá
Alcalá de Henares, , Spain
Universidad Rey Juan Carlos
Alcorcón, , Spain
Universidad CEU Cardenal Herrera
Valencia, , Spain
Universidad de Valencia
Valencia, , Spain
Countries
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References
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Van Oosterwijck J, Meeus M, Paul L, De Schryver M, Pascal A, Lambrecht L, Nijs J. Pain physiology education improves health status and endogenous pain inhibition in fibromyalgia: a double-blind randomized controlled trial. Clin J Pain. 2013 Oct;29(10):873-82. doi: 10.1097/AJP.0b013e31827c7a7d.
van Ittersum MW, van Wilgen CP, Groothoff JW, van der Schans CP. Is appreciation of written education about pain neurophysiology related to changes in illness perceptions and health status in patients with fibromyalgia? Patient Educ Couns. 2011 Nov;85(2):269-74. doi: 10.1016/j.pec.2010.09.006. Epub 2010 Sep 29.
Boomershine CS. A comprehensive evaluation of standardized assessment tools in the diagnosis of fibromyalgia and in the assessment of fibromyalgia severity. Pain Res Treat. 2012;2012:653714. doi: 10.1155/2012/653714. Epub 2011 Oct 10.
Bowering KJ, O'Connell NE, Tabor A, Catley MJ, Leake HB, Moseley GL, Stanton TR. The effects of graded motor imagery and its components on chronic pain: a systematic review and meta-analysis. J Pain. 2013 Jan;14(1):3-13. doi: 10.1016/j.jpain.2012.09.007. Epub 2012 Nov 15.
Other Identifiers
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CEI14 / 008
Identifier Type: -
Identifier Source: org_study_id
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