NCT07280273

Effectiveness of Pain Science Education in Patients With Fibromyalgia Syndrome Living in Rural Areas.

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: María Catalina Osuna Pérez · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia Syndrome

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2025-12-22
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2025-12-12
• Last updated: 2026-01-22

Locations

1 site across 1 country: Spain