Clinical trial NCT02474875: Explain Pain in Fibromyalgia Patients
Official title: Explain Pain in Fibromyalgia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Patient education
Central sensitization
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
name: University of Alcala
name: University of Valencia
First posted: 2015-06-18
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Education of pain physiology is described as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system. There is compelling evidence that an educational strategy addressing neurophysiology and neurobiology of pain can have a positive effect on pain, disability, catastrophization, and physical performance in chronic musculoskeletal pain disorders. Although pain physiology education has been studied in patients with chronic low back pain, chronic whiplash, and chronic fatigue syndrome in combination with widespread pain, studies in fibromyalgia (FM) are limited to a 2013 study with limited results.

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.


Eligibility criteria: Inclusion Criteria:

* American College of Rheumatology classification criteria for FM, both 1990 and 2010
* 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:

* Suffer from an inflammatory rheumatic conditions
* 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

Primary outcomes:
measure: Change in Visual Analog Scale
timeFrame: Baseline - 6 weeks - 3 months
Secondary outcomes:
measure: Change in Fibromyalgia Impact Questionnaire
timeFrame: Baseline - 6 weeks - 3 months
measure: Change in Pressure Pain Threshold
timeFrame: Baseline - 6 weeks - 3 months
measure: Change in Medical Outcomes Study Short Form 36 (SF-36)
timeFrame: Baseline - 6 weeks - 3 months
measure: Change in Patient Global Impression of Change Scale
timeFrame: Baseline - 6 weeks - 3 months
measure: Change in Depression subscale of the Hospital Anxiety and Depression Scale
timeFrame: Baseline - 6 weeks - 3 months
measure: Change in Fatigue Severity Scale
timeFrame: Baseline - 6 weeks - 3 months
measure: Change in Jenkins Sleep Scale
timeFrame: Baseline - 6 weeks - 3 months
measure: Change in Manual Tender Point Survey
timeFrame: Baseline - 6 weeks - 3 months
measure: Change in Neurophysiology of Pain Test
timeFrame: Baseline - 6 weeks - 3 months
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Unviversidad de Alcalá
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
city: Valencia
country: Spain
facility: Universidad CEU Cardenal Herrera
city: Valencia
country: Spain
facility: Universidad de Valencia
Study officials:
affiliation: Head of Physical Therapy Department
name: Juan J. Amer-Cuenca
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.