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RECRUITING
NCT06097091
NA

Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia

Sponsor: Taipei Medical University

View on ClinicalTrials.gov

Summary

This randomized controlled trials study aims, first, to determine the effectiveness of a nurse-led PNE program designed by a multidisciplinary team, compared with an active control group on pain intensity, fibromyalgia (FM) severity, pain catastrophizing, and cognitive performance in patients with FM. Second, to determine the mediator role of pain catastrophizing in the effects of PNE on outcomes of interest. Third, to explore PNE-induced changes to the brain circuitry using QEEG in patients with FM.

Official title: Effects and Mechanisms of Pain Neuroscience Education on Pain Severity, Disease Severity, Pain Catastrophizing, and Cognitive Function in Patients With Fibromyalgia : A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2023-09-06

Completion Date

2026-07-31

Last Updated

2024-11-20

Healthy Volunteers

No

Conditions

Interventions

OTHER

Self-management education

A self-management of the FM handbook will be provided. SME will be delivered via weekly video calls over a 6-week period. The video call lasting for 15 minutes, will consist of reviewing the weekly self-management content (5 min), questioning and answering related to the content of the self-management handbook (5 min), and a debriefing session (5 min).

BEHAVIORAL

pain neuroscience education

Participants in the experimental group will receive a 6-week PNE program. The PNE program that is designed to explain pain to the participants will be implemented via 6 individual face-to-face sessions, each lasting for 45 minutes over a 6-week period. Printed take-home materials will be provided to the participants to enhance learning. The goal of PNE is to increase participants' knowledge about pain to help them reconceptualize their beliefs about pain and decrease perceived threats of pain. The content will be composed according to the second edition of the book, "Explain Pain" by Butler and Mosley (2013) as well as etiologies of fibromyalgia. Accordingly, the PI has developed the preliminary PNE content.

Locations (1)

Bio-Behavior Research Laboratory

Taipei, Taiwan