Clinical trial NCT06097091: 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
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
cognitive function
disease severity
pain catastrophizing
pain neuroscience education
pain severity
quantitative electroencephalography
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2023-10-24
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: baseline; T1 = immediately after PNE; T2 = 3th month after intervention.
measure: the Fibromyalgia Impact Questionnaire Revised (FIQR)
timeFrame: baseline; T1 = immediately after PNE; T2 = 3th month after intervention.
Secondary outcomes:
measure: Pain Catastrophizing Scale(PCS)
timeFrame: baseline; T1 = immediately after PNE; T2 = 3th month after intervention.
measure: Psychomotor Vigilance Test (PVT)
timeFrame: baseline; T1 = immediately after PNE; T2 = 3th month after intervention.
Other outcomes:
measure: Quantitative electroencephalography
timeFrame: baseline; T1 = immediately after PNE; T2 = 3th month after intervention.
Locations:
city: Taipei
country: Taiwan
facility: Bio-Behavior Research Laboratory
Study officials:
affiliation: Taipei Medical University, Taiwan
name: Pei-Shan Tsai, PhD
role: STUDY_CHAIR
References: