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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- the Fibromyalgia Impact Questionnaire Revised (FIQR)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
We will employ a triple masking protocol in which the PNE educator, participants, and data collectors will all be blinded to group assignments. In addition, we will mask the group assignment to the data analyzer.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must read and understand Chinese language.
- •According to the 2016 ACR diagnostic criteria, participants' PDS scores more than or equal to 13 points
排除标准
- •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.
结局指标
主要结局
the Fibromyalgia Impact Questionnaire Revised (FIQR)
时间窗: baseline; T1 = immediately after PNE; T2 = 3th month after intervention.
The FIQR includes 21 questions involving 3 domains: physical function, overall effect of fibromyalgia, and fibromyalgia symptoms (pain, fatigue, unrefreshing sleep, stiffness, anxiety, depression, tenderness to touch, memory, balance, and environmental sensitivity).
the Brief Pain Inventory-Short Form (BPI-SF)
时间窗: baseline; T1 = immediately after PNE; T2 = 3th month after intervention.
The BPI-SF evaluates pain in different contexts: worst pain, least pain, average pain, and current pain, rated on a 0-10 scale.
次要结局
- Pain Catastrophizing Scale(PCS)(baseline; T1 = immediately after PNE; T2 = 3th month after intervention.)
- Psychomotor Vigilance Test (PVT)(baseline; T1 = immediately after PNE; T2 = 3th month after intervention.)
研究者
Pei-Shan, Tsai
Principal Investigator
Taipei Medical University