Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06097091
• Other study ID #: N202305118
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: October 2023
• Source: Taipei Medical University
• Contact: Pei-Shan Tsai, PhD
• Phone: +88627361661
• Email: ptsai[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a parallel-group, randomized controlled trial (RCT). 98 participants who meet the 2016 American College of Rheumatology diagnostic criteria for FM will be enrolled. Eligible participants who complete the baseline measurements will be randomly allocated to a PNE group (N = 49) and a self-management education group (N = 49). Primary outcomes include pain severity determined using the Brief Pain Inventory-Short Form (BPI-SF) and FM severity assessed using the Fibromyalgia Impact Questionnaire-Revised (FIQR). Secondary outcomes, including pain catastrophizing and sustained attention, will examine using the Pain Catastrophizing Scale (PCS), the Psychomotor Vigilance Test (PVT), and QEEG, respectively. All outcomes will be measured at 3 different time points: (T0: baseline; T1: immediately after the 6-week intervention period; and T2: 3 months after the intervention period). Implications: This will be the first-ever RCT to examine the effectiveness of a Chinese-language PNE program and the first study to determine the brain changes after PNE using QEEG in patients with FM. Once the effectiveness of the PNE and its brain mechanisms are supported by evidence from this trial, it will become a game changer in the management of the FM population. If an evidence-based PNE platform based on the patented training course is subsequently developed, the product will have great potential for commercialization.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: July 31, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Country	Name	City	State
Taiwan	Bio-Behavior Research Laboratory	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quantitative electroencephalography	Resting-state EEG measurements with eyes closed will be taken for 10 min using the BrainMaster Discovery 24 EEG device. The participants will be seated with their eyes closed for 20 min before the measurements to achieve this stable/resting state. Five minutes of artifact-free EEG will be used in this study.	baseline; T1 = immediately after PNE; T2 = 3th month after intervention.
Primary	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.
Primary	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	Pain Catastrophizing Scale(PCS)	The PCS is a self-reported questionnaire consisting of 13 items that assess negative emotional and cognitive processes (e.g., helplessness, rumination, pessimism, and magnification of symptoms).	baseline; T1 = immediately after PNE; T2 = 3th month after intervention.
Secondary	Psychomotor Vigilance Test (PVT)	The standard 3-minute PVT will be used in this study to assess sustained or vigilant attention. The PVT is performed by recording the response time to visual stimuli, occurring at random inter stimulus intervals.	baseline; T1 = immediately after PNE; T2 = 3th month after intervention.