Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia

Last updated: November 19, 2024
Sponsor: Taipei Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fibromyalgia

Treatment

pain neuroscience education

Self-management education

Clinical Study ID

NCT06097091
N202305118
  • Ages 18-64
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must read and understand Chinese language.

  • According to the 2016 ACR diagnostic criteria, participants' PDS scores more than orequal to 13 points

Exclusion

Exclusion Criteria:

  • Subjects who have medical history of traumatic brain injury or neurologicaldisorder.

  • Subjects who have present psychopathologic disorder.

  • Subjects who are cancer.

  • Subjects who are pregnancy.

Study Design

Total Participants: 98
Treatment Group(s): 2
Primary Treatment: pain neuroscience education
Phase:
Study Start date:
September 06, 2023
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Bio-Behavior Research Laboratory

    Taipei,
    Taiwan

    Active - Recruiting

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