Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia

Not Applicable

Recruiting

• Conditions: Fibromyalgia
• Interventions: Other: Self-management education; Behavioral: pain neuroscience education

• Registration Number: NCT06097091
• Lead Sponsor: Taipei Medical University

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.

Detailed 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.

Study Timeline

• Study Start: 2023-09-06
• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Primary Completion: 2026-02-28
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Management Education	Self-management education	Participants in the control group will receive an SME via weekly video calls over 6 weeks.
Pain Neuroscience Education	pain neuroscience education	Participants in the experimental group will receive a 6-week PNE program.

Primary Outcome Measures

Name	Time	Method
the Fibromyalgia Impact Questionnaire Revised (FIQR)	baseline; T1 = immediately after PNE; T2 = 3th month after intervention.	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).
the Brief Pain Inventory-Short Form (BPI-SF)	baseline; T1 = immediately after PNE; T2 = 3th month after intervention.	The BPI-SF evaluates pain in different contexts: worst pain, least pain, average pain, and current pain, rated on a 0-10 scale.

Secondary Outcome Measures

Name	Time	Method
Pain Catastrophizing Scale(PCS)	baseline; T1 = immediately after PNE; T2 = 3th month after intervention.	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).
Psychomotor Vigilance Test (PVT)	baseline; T1 = immediately after PNE; T2 = 3th month after intervention.	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.

Trial Locations

Locations (1)

Bio-Behavior Research Laboratory; 🇨🇳 Taipei, Taiwan