search
Back to results

Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Self-management education
pain neuroscience education
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, cognitive function, disease severity, pain catastrophizing, pain neuroscience education, pain severity, quantitative electroencephalography

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bio-Behavior Research LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Self-Management Education

Pain Neuroscience Education

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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).
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.

Full Information

First Posted
October 18, 2023
Last Updated
October 18, 2023
Sponsor
Taipei Medical University
Collaborators
Ministry of Science and Technology, Taiwan
search

1. Study Identification

Unique Protocol Identification Number
NCT06097091
Brief Title
Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2023 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
Collaborators
Ministry of Science and Technology, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, cognitive function, disease severity, pain catastrophizing, pain neuroscience education, pain severity, quantitative electroencephalography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-Management Education
Arm Type
Active Comparator
Arm Description
Participants in the control group will receive an SME via weekly video calls over 6 weeks.
Arm Title
Pain Neuroscience Education
Arm Type
Experimental
Arm Description
Participants in the experimental group will receive a 6-week PNE program.
Intervention Type
Other
Intervention Name(s)
Self-management education
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
pain neuroscience education
Intervention Description
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.
Primary Outcome Measure Information:
Title
the Brief Pain Inventory-Short Form (BPI-SF)
Description
The BPI-SF evaluates pain in different contexts: worst pain, least pain, average pain, and current pain, rated on a 0-10 scale.
Time Frame
baseline; T1 = immediately after PNE; T2 = 3th month after intervention.
Title
the Fibromyalgia Impact Questionnaire Revised (FIQR)
Description
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).
Time Frame
baseline; T1 = immediately after PNE; T2 = 3th month after intervention.
Secondary Outcome Measure Information:
Title
Pain Catastrophizing Scale(PCS)
Description
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).
Time Frame
baseline; T1 = immediately after PNE; T2 = 3th month after intervention.
Title
Psychomotor Vigilance Test (PVT)
Description
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.
Time Frame
baseline; T1 = immediately after PNE; T2 = 3th month after intervention.
Other Pre-specified Outcome Measures:
Title
Quantitative electroencephalography
Description
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.
Time Frame
baseline; T1 = immediately after PNE; T2 = 3th month after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Shan Tsai, PhD
Phone
+88627361661
Ext
6321
Email
ptsai@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Shan Tsai, PhD
Organizational Affiliation
Taipei Medical University, Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Bio-Behavior Research Laboratory
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei-Shan Tsai, PhD
Phone
88627361661
Ext
6321
Email
ptsai@tmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Pei-Shan Tsai, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia

We'll reach out to this number within 24 hrs