Effectiveness of Pain Neuroscience Education and Strength Training Program in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from Disability
研究概览
简要总结
The main goal of this study is to get to know if applying both, pain neuroscience education (PNE) plus strength training (ST) will reduce the pain of fibromyalgia (FM). Both therapies have shown evidence of improvement in fibromyalgia patients. However, there are no studies evaluating their efficacy in combination.
详细描述
At present, the increase in knowledge about the neuroscience of pain has led to the integration of psychological factors, such as cognitions and beliefs about pain, fear-avoidance behaviors or catastrophism within the integrative perception of the concept . This has led to the development of therapeutic strategies aimed at the reconceptualization of pain through a treatment method called Pain Neuroscience Education (PNE), having shown evidence in the treatment of pain, disability, catastrophism and physical performance.
But despite current advances in pain neuroscience, there are still pain syndromes, such as fibromyalgia, that are the subject of debate and controversy. Fibromyalgia is a syndrome that causes generalized musculoskeletal pain, fatigue, sleep disorders, and physical disability. It is the main cause of chronic generalized musculoskeletal pain, with a prevalence of 1-5% of the world population. Scientific research has provided new insight for the diagnosis of fibromyalgia patients, who are characterized by a central sensitization process.
Objectives:
To assess the effectiveness of Pain Neuroscience Education and Strength Training to decrease pain and disability; and increasing quality of life and functionality in patients with Fibromyalgia.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women diagnosed with fibromyalgia.
- •Duration of pain greater than one year.
- •Generalized or present pain in more than two body regions.
- •Not having participated in pain neuroscience education program.
- •Not having participated in physical exercise programs in the last three months.
排除标准
- •Presence of other diseases not related to the musculoskeletal system.
- •Being under medical treatment not related to pain.
- •being under physiotherapeutic treatment related to pain.
- •Unavailability to carry out a physical exercise program.
- •Pregnant or puerperium women.
- •Inability to perform or complete the necessary tests to measure the study variables.
结局指标
主要结局
Change from Disability
时间窗: at the start of the study (at baseline, 0 week), after the last treatment session (12th week), 1 month from the last session (16th week), 3 months from the last session (20th week) and 6 months from the last session (32th week)
Measured by the Fibromyalgia Impact Questionnaire (FIQ). The total FIQ score is between 0-100. Thus, 0 represents the highest functional capacity and quality of life and 100 the worst state.
Change from Self-report Pain Intensity
时间窗: at the start of the study (at baseline, 0 week), after the last treatment session (12th week), 1 month from the last session (16th week), 3 months from the last session (20th week) and 6 months from the last session (32th week).
Evaluated by the visual analogue scale (VAS). The total VAS score is between 0-10 cm. A higher score indicates greater pain intensity
Change from Central Sensitization symptoms
时间窗: at the start of the study (at baseline, 0 week), after the last treatment session (12th week), 1 month from the last session (16th week), 3 months from the last session (20th week) and 6 months from the last session (32th week)
Measured by the Central Sensitization Inventory (CSI). The total CSI score is between 0-100 points. Scores equal to or greater than 40 points are considered positive for Central Sensitization.
次要结局
- Change from the pressure pain threshold(at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)])
- Change from viscoelastic properties.(at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)])
- Change from grip strength(at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)])
- Change from Nerve Conduction Velocity(at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)])
- Change from Autonomic Disfunction symptoms(at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)])
研究者
Manuel Rebollo Salas
Director
University of Seville