Pain Neuroscience Education and Motor Imagery-based Exercise Protocol in Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
The main aim of this study is to find out whether applying both pain neuroscience education (PNE) and motor imagery-based exercise protocol (MIEP) will primarily reduce the pain of fibromyalgia. These therapies could show an evidence of improvement in fibromyalgia patients. However, there are no studies evaluating their effectiveness in combination.
Secondary outcomes:
To assess motor imagery ability of PNE in fibromyalgia patients
To assess motor imagery ability of MIEP in fibromyalgia patients
To evaluate the motor imagery ability of PNE+MIEP combined in fibromyalgia patients
To evaluate pain beliefs of PNE in fibromyalgia patients
To assess the pain beliefs of MIEP in fibromyalgia patients
Combined PNE+MIEP to assess pain beliefs in fibromyalgia patients.
To assess fear of movement in fibromyalgia patients of PNE
To assess fear of movement in fibromyalgia patients of MIEP
Combined PNE+MIEP to assess fear of movement in patients with fibromyalgia
PNE to assess anxiety, depression, cognitive and mood in patients with fibromyalgia.
To assess anxiety, depression, cognitive and mood in patients with fibromyalgia MIEP
To evaluate anxiety, depression, cognitive and mood in patients with fibromyalgia together with PNE+MIEP
PNE to assess self-esteem and body awareness in fibromyalgia patients.
To assess self-esteem and body awareness in fibromyalgia patients of MIEP
Combined PNE+MIEP to assess self-esteem and body awareness in fibromyalgia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experiencing widespread chronic pain for more than 12 months
- •Pain in at least 12 or more of 18 tender points with a pressure of 5 kg/cm2
- •18 to 60 years old
- •Not using pharmacological therapeutics
- •Not having participated in any pain program.
- •Not having participated in any physical exercise programs in the last twelve
排除标准
- •Pregnancy
- •Not being able to do a physical activity program
- •Currently receiving treatment with any alternative medical methods (eg.hyperbaric).
- •Cardiovascular, psychiatric, autoimmune, cancer, etc. children with secondary different disease
- •Other causes of chronic pain
- •Receiving any treatment support related to pain
- •Mental disability status
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: 12 weeks
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
次要结局
- The Pain Catastrophizing Scale (PCS)(12 weeks)
- The Pain Beliefs Questionnaire (PBQ)(12 weeks)
- Rosenberg Self-esteem Scale(12 weeks)
- Adapting the Scale of Cognitive Emotion Regulation Strategies(12 weeks)
- The Motion Imagery Questionnaire-3 (HLFS-3)(12 weeks)
- The Tampa Scale for Kinesiophobia (TSK)(12 weeks)
- Hospital Anxiety and Depression Scale (HADS)(12 weeks)
- The Body Awareness Questionnaire(12 weeks)
研究者
Mesut Karahan
Assoc. Prof.
Uskudar University