Effectiveness of Pain Science Education in Patients With Fibromyalgia Syndrome Living in Rural Areas.
NCT ID: NCT07280273
Last Updated: 2026-01-22
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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RECRUITING
NA
54 participants
INTERVENTIONAL
2025-12-22
2026-06-30
Brief Summary
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The objective of this study is to evaluate the effectiveness of PSE in patients with FMS living in rural areas. They will be randomly assigned to one of two treatment groups. The intervention group will receive two adapted in-person sessions (90 minutes per session/week) by a therapist experienced in teaching PSE. The control group will begin the conventional treatment they received before participating in the study. After the end of the study, patients in the control group will be given their intervention group records. The variables measured will include the impact of FMS on daily life, pain sensitivity, central sensitization, pain catastrophizing, fear of movement, anxiety and depression, self-efficacy, and assessment of knowledge and beliefs about PSE. Assessments will be conducted before the intervention, after the second PSE session, and three months later by the same researcher.
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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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PSE group
Pain Science Education
The intervention group will receive two 90-minute in-person Pain Education sessions, each delivered one week apart. The intervention will be delivered by a therapist experienced in educational interventions. The session content will be based on the most recent literature, clinical practice guidelines, and published literature on pain science, addressing concepts in a simple way so that patients can integrate them into their daily lives, with the goal of changing their knowledge and beliefs about pain. Images and metaphors will be used, avoiding the use of technical language to ensure knowledge transfer. After each session, any questions that may have arisen will be addressed. Participants will be given a dossier containing the session content to reinforce and integrate the knowledge acquired during the sessions, without providing additional information.
Control group
No interventions assigned to this group
Interventions
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Pain Science Education
The intervention group will receive two 90-minute in-person Pain Education sessions, each delivered one week apart. The intervention will be delivered by a therapist experienced in educational interventions. The session content will be based on the most recent literature, clinical practice guidelines, and published literature on pain science, addressing concepts in a simple way so that patients can integrate them into their daily lives, with the goal of changing their knowledge and beliefs about pain. Images and metaphors will be used, avoiding the use of technical language to ensure knowledge transfer. After each session, any questions that may have arisen will be addressed. Participants will be given a dossier containing the session content to reinforce and integrate the knowledge acquired during the sessions, without providing additional information.
Eligibility Criteria
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Inclusion Criteria
* Residence in a rural area of the province of Jaén (Spain).
* Age between 18 and 65 years.
* Spanish reading ability.
* Understanding and acceptance of the informed consent form to participate in the study.
Exclusion Criteria
* Patients diagnosed with inflammatory rheumatic disease.
* Having a scheduled surgical intervention during the data collection process that could interfere with the results.
* Being pregnant or breastfeeding.
* Modification of pharmacological treatment during the study or in the last three months before the intervention.
These criteria have been established from a review of other clinical trials conducted with similar interventions in patients with FMS.
18 Years
65 Years
ALL
No
Sponsors
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María Catalina Osuna Pérez
OTHER
Responsible Party
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María Catalina Osuna Pérez
Full professor at the university
Principal Investigators
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María Catalina Osuna-Pérez, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Jaén
Noelia Zagalaz Anula, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Jaén
Locations
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Fisio Mas, Peal de Becerro
Jaén, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Salazar-Mendez J, Nunez-Cortes R, Suso-Marti L, Ribeiro IL, Garrido-Castillo M, Gacitua J, Mendez-Rebolledo G, Cruz-Montecinos C, Lopez-Bueno R, Calatayud J. Dosage matters: Uncovering the optimal duration of pain neuroscience education to improve psychosocial variables in chronic musculoskeletal pain. A systematic review and meta-analysis with moderator analysis. Neurosci Biobehav Rev. 2023 Oct;153:105328. doi: 10.1016/j.neubiorev.2023.105328. Epub 2023 Jul 27.
Ceballos-Laita L, Mingo-Gomez MT, Navas-Camara F, Estebanez-de-Miguel E, Caudevilla-Polo S, Verde-Rello Z, Fernandez-Araque A, Jimenez-Del-Barrio S. Therapeutic Exercise and Pain Neurophysiology Education in Female Patients with Fibromyalgia Syndrome: A Feasibility Study. J Clin Med. 2020 Nov 5;9(11):3564. doi: 10.3390/jcm9113564.
Boomershine CS. Fibromyalgia: the prototypical central sensitivity syndrome. Curr Rheumatol Rev. 2015;11(2):131-45. doi: 10.2174/1573397111666150619095007.
Sauch Valmana G, Miro Catalina Q, Carrasco-Querol N, Vidal-Alaball J. Gender, Mental Health and Socioeconomic Differences in Fibromyalgia: A Retrospective Cohort Study Using Real-World Data from Catalonia. Healthcare (Basel). 2023 Feb 10;11(4):530. doi: 10.3390/healthcare11040530.
Catala P, Blanco S, Perez-Calvo S, Luque-Reca O, Bedmar D, Penacoba C. Does the Rural Environment Influence Symptomatology and Optimize the Effectiveness of Disease Acceptance? A Study Among Women With Fibromyalgia. Front Psychol. 2021 Apr 29;12:658974. doi: 10.3389/fpsyg.2021.658974. eCollection 2021.
Font Gaya T, Bordoy Ferrer C, Juan Mas A, Seoane-Mato D, Alvarez Reyes F, Delgado Sanchez M, Martinez Dubois C, Sanchez-Fernandez SA, Marena Rojas Vargas L, Garcia Morales PV, Olive A, Rubio Munoz P, Larrosa M, Navarro Ricos N, Sanchez-Piedra C, Diaz-Gonzalez F, Bustabad-Reyes S; Working Group Proyecto EPISER2016. Prevalence of fibromyalgia and associated factors in Spain. Clin Exp Rheumatol. 2020 Jan-Feb;38 Suppl 123(1):47-52. Epub 2020 Jan 8.
Bidonde J, Busch AJ, Schachter CL, Webber SC, Musselman KE, Overend TJ, Goes SM, Dal Bello-Haas V, Boden C. Mixed exercise training for adults with fibromyalgia. Cochrane Database Syst Rev. 2019 May 24;5(5):CD013340. doi: 10.1002/14651858.CD013340.
Al Sharie S, Varga SJ, Al-Husinat L, Sarzi-Puttini P, Araydah M, Bal'awi BR, Varrassi G. Unraveling the Complex Web of Fibromyalgia: A Narrative Review. Medicina (Kaunas). 2024 Feb 4;60(2):272. doi: 10.3390/medicina60020272.
Queiroz LP. Worldwide epidemiology of fibromyalgia. Curr Pain Headache Rep. 2013 Aug;17(8):356. doi: 10.1007/s11916-013-0356-5.
Other Identifiers
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PSE-RURAL
Identifier Type: -
Identifier Source: org_study_id
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