Effectiveness of a Structured Group Intervention Based on Pain Neuroscience Education for Patients With Fibromyalgia in Primary Care: a Multicenter Randomized Open-label Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 主要终点
- To asses the number of patients that stop fulfilling fibromyalgia criteria (American College of Reumathology 2010 criteria).
研究概览
简要总结
Fibromyalgia (FM) is a chronic, complex and disabling clinical entity that has an average global prevalence of 2.7%. It occurs mainly in women in a 3: 1 ratio. It is characterized by persistent generalized pain, fatigue, unrefreshing sleep, cognitive dysfunction and numerous systemic symptoms such as dizziness, migraine, digestive alterations or sensory intolerances. At present there is no pharmacological treatment with specific indication for fibromyalgia. Usually, non-curative treatments are recommended that alleviate the symptoms of the patients and improve their quality of life and functionality.
The investigator's main goal is to evaluate the effectiveness at 1 year of a group educational intervention in neurobiology of pain in patients affected by fibromyalgia, in comparison with the evolution of a control group that will continue only with its usual treatments. This intervention will be carried out in the field of Primary Care and its effectiveness will be assessed by reducing or not having diagnostic criteria (reduction of areas of pain and of the severity of fibromyalgia symptoms), using the Criteria for the Diagnosis of Fibromyalgia of the American College of Rheumatology 2010 (ACR 2010).
详细描述
Methodology of the project In group sessions of 14 patients, a health professional explained the neurological mechanisms that are behind the perception of pain, fatigue and illness from the recent knowledge in neuroscience about brain and pain, as well as the brain's ability to change patien´s behaviour thanks to neuroplasticity.
There will be 5 sessions of 2 hours per week and another one per month. Before the latter, a workshop of 2 hours of movement will be given.
Each week the contents of the class and other complementary materials will be sent to the patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of fibromyalgia stablished by the American Rheumatology College criteria 2010,
- •Older than 18 years
- •Have signed the informed consent
排除标准
- •Psychiatric or neurological disorder which could prevent assimilate the training
- •Refusal to participate in the trial
结局指标
主要结局
To asses the number of patients that stop fulfilling fibromyalgia criteria (American College of Reumathology 2010 criteria).
时间窗: It will be measured at 12-months after the beginning of the intervention,
The criteria established by the American College of Reumathology 2010 will be measured to estimate the negativization of the fibromyalgia diagnostic criteria. (Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Ménard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovský J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584. PubMed PMID: 20872595.
次要结局
- To asses the effectiveness by modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size.(It will be measured at 1 month, 6 months and 12-months after the beginning of the intervention,)
- To asses the decrease in pain by modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size.(t will be measured at 1 month, 6 months and 12-months after the beginning of the intervention,)
- To assesthe decrease in catastrophising by modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size.(t will be measured at 1 month, 6 months and 12-months after the beginning of the intervention,)
- To asses the decrease in anxiety and depression by modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size.(t will be measured at 1 month, 6 months and 12-months after the beginning of the intervention,)
- To asses the security of modified- PNE to improve fibromyalgia symptoms and security; meassured by effecte size and group intervention time size.(It will be measured at 12-months after the beginning of the intervention,)
研究者
maría muñoa capron-manieux
Head of Primary Care Setting (Alango)
Osatzen Sociedad Vasca Medicina Familiar y Comunitaria