Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia
NCT ID: NCT06097091
Last Updated: 2024-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
98 participants
INTERVENTIONAL
2023-09-06
2026-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Self-Management Education
Participants in the control group will receive an SME via weekly video calls over 6 weeks.
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).
Pain Neuroscience Education
Participants in the experimental group will receive a 6-week PNE program.
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.
Interventions
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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).
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.
Eligibility Criteria
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Inclusion Criteria
* According to the 2016 ACR diagnostic criteria, participants' PDS scores more than or equal to 13 points
Exclusion Criteria
* Subjects who have present psychopathologic disorder.
* Subjects who are cancer.
* Subjects who are pregnancy.
18 Years
64 Years
ALL
No
Sponsors
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Ministry of Science and Technology, Taiwan
OTHER_GOV
Taipei Medical University
OTHER
Responsible Party
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Pei-Shan, Tsai
Principal Investigator
Principal Investigators
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Pei-Shan Tsai, PhD
Role: STUDY_CHAIR
Taipei Medical University, Taiwan
Locations
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Bio-Behavior Research Laboratory
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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N202305118
Identifier Type: -
Identifier Source: org_study_id
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