Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia

NCT06097091 | Recruiting

• 1 other identifier: N202305118
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; cognitive function; disease severity; pain catastrophizing; pain neuroscience education; pain severity; quantitative electroencephalography

Outcome Measures

Primary Outcomes (2)

• the Brief Pain Inventory-Short Form (BPI-SF)

  The BPI-SF evaluates pain in different contexts: worst pain, least pain, average pain, and current pain, rated on a 0-10 scale.

  baseline; T1 = immediately after PNE; T2 = 3th month after intervention.

• the Fibromyalgia Impact Questionnaire Revised (FIQR)

  The FIQR includes 21 questions involving 3 domains: physical function, overall effect of fibromyalgia, and fibromyalgia symptoms (pain, fatigue, unrefreshing sleep, stiffness, anxiety, depression, tenderness to touch, memory, balance, and environmental sensitivity).

  baseline; T1 = immediately after PNE; T2 = 3th month after intervention.

Secondary Outcomes (2)

• Pain Catastrophizing Scale(PCS)

  baseline; T1 = immediately after PNE; T2 = 3th month after intervention.

• Psychomotor Vigilance Test (PVT)

  baseline; T1 = immediately after PNE; T2 = 3th month after intervention.

Other Outcomes (1)

• Quantitative electroencephalography

  baseline; T1 = immediately after PNE; T2 = 3th month after intervention.

Study Arms (2)

Self-Management Education

ACTIVE COMPARATOR

Participants in the control group will receive an SME via weekly video calls over 6 weeks.

Other: Self-management education

Pain Neuroscience Education

EXPERIMENTAL

Participants in the experimental group will receive a 6-week PNE program.

Behavioral: pain neuroscience education

Interventions

Self-management education OTHER

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).

Self-Management Education

pain neuroscience education BEHAVIORAL

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.

Pain Neuroscience Education

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must read and understand Chinese language.
• According to the 2016 ACR diagnostic criteria, participants' PDS scores more than or equal to 13 points

You may not qualify if:

• Subjects who have medical history of traumatic brain injury or neurological disorder.
• Subjects who have present psychopathologic disorder.
• Subjects who are cancer.
• Subjects who are pregnancy.

Sponsors & Collaborators

• Taipei Medical University: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Bio-Behavior Research Laboratory

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pei-Shan Tsai, PhD

  Taipei Medical University, Taiwan

  STUDY CHAIR

Central Study Contacts

Pei-Shan Tsai, PhD

CONTACT

+88627361661; ptsai@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: We will employ a triple masking protocol in which the PNE educator, participants, and data collectors will all be blinded to group assignments. In addition, we will mask the group assignment to the data analyzer.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: September 6, 2023
• Primary Completion: February 28, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)