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Effectiveness of Pain Science Education (PSE) in Patients With Fibromyalgia Syndrome (FMS) Living in Rural Areas.: a Randomized Clinical Trial.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Fibromyalgia Syndrome (FMS) is a complex chronic pain disorder characterized by widespread pain associated with numerous symptoms. It is more common in women over 50 years of age with low educational and socioeconomic status living in rural areas. Pain Science Education (PSE) is one of the most widely used treatments for chronic pain management. This treatment consists of an educational intervention aimed at reconceptualizing and modifying erroneous cognitions regarding pain in these patients. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• Diagnosis of FM that meets the 2016 American College of Rheumatology (ACR) diagnostic 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.

Locations
Other Locations
Spain
Fisio Mas, Peal de Becerro
RECRUITING
Jaén
Contact Information
Primary
María Catalina Osuna-Pérez, PhD
mcosuna@ujaen.es
(+34) 953 213020
Backup
Noelia Zagalaz-Anula, PhD
nzagalaz@ujaen.es
Time Frame
Start Date: 2025-12-22
Estimated Completion Date: 2026-06
Participants
Target number of participants: 54
Treatments
Experimental: PSE group
No_intervention: Control group
Related Therapeutic Areas
Sponsors
Leads: María Catalina Osuna Pérez

This content was sourced from clinicaltrials.gov