Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia

Taipei Medical University

Status: Enrolling

Conditions: Fibromyalgia

Treatments: Other: Self-management education; Behavioral: pain neuroscience education

Study type: Interventional

Funder types: Other

Identifiers

NCT06097091

N202305118

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

Self-Management Education

Active Comparator group

Description:

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

Treatment:

Other: Self-management education

Pain Neuroscience Education

Experimental group

Description:

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

Treatment:

Behavioral: pain neuroscience education