Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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).
• Поведенческое 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. T

Первичные конечные точки

• the Brief Pain Inventory-Short Form (BPI-SF) [Срок оценки: baseline; T1 = immediately after PNE; T2 = 3th month after intervention.]
• the Fibromyalgia Impact Questionnaire Revised (FIQR) [Срок оценки: baseline; T1 = immediately after PNE; T2 = 3th month after intervention.]

Вторичные конечные точки (2)

• Pain Catastrophizing Scale(PCS) [Срок оценки: baseline; T1 = immediately after PNE; T2 = 3th month after intervention.]
• Psychomotor Vigilance Test (PVT) [Срок оценки: baseline; T1 = immediately after PNE; T2 = 3th month after intervention.]

Критерии участия

Критерии включения

• Participants must read and understand Chinese language.
• According to the 2016 ACR diagnostic criteria, participants' PDS scores more than or equal to 13 points

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Bio-Behavior Research Laboratory — Taipei

Идентификаторы

NCT: NCT06097091 · N202305118

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗