Biobehavioral Physical Therapy Strategies Based on Therapeutic Exercise Applied to Chronic Migraine Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Quality of Life measured by the HIT-6 Questionnaire
研究概览
简要总结
The purpose of this study is to know wich combination of treatments are the most effective in patients with chronic migraine. The study design is a simple blind randomized controlled trial (outcomes assessor). The study population: Men and women aged from 18 to 70 years old with chronic migraine for at least 12 weeks. Interventions: A combination of techniques during 6 weeks (6 sessions; 1 per week)
详细描述
Migraine is a neurological disease characterized by attacks of pulsating headache on one side of the head, presenting autonomic nervous system disfunction. Migraine is associated to significant personal and social burden. Physical activity could worsen patient´s symptoms. Migraine is associated with nausea, vomiting, photophobia and phonophobia Chronic migraine patients according to the third IHS ( International Headache Society) classification suffer headache at least 15 days per month no less than 3 months.
According to Pozo-Rosich et al., migraine incidence worldwide is 2% of the general population. In the US the 18% of migraine patients are females corresponding the 6% to males.
As comorbid diseases usually associated to migraine are found disability, depression, anxiety and biobehavioral disorders. Migraine is a chronic disease which cause biopsychosocial damage and decrease quality of life in its patients. Risk factors to endure Migraine are sex (females), obesity and overuse of headache medicaments.
Migraine origin and its physiopathology in unknown although there are several studies that support a central sensitization mechanism at the level of trigeminocervical complex to explain migraine. Trigeminocervical complex is made by the convergence between superior neurons of the trigeminal nucleus caudalis and the dorsal cervical horns of the first and second cervical levels.
Some authors suggest that it is a biobehavioral disorder that results from a cortical hypersensitivity and an associated social learning process. Behavioral habits and medication intake due to migraine attacks are important factors to keep in mind. Stanos et al. concluded that the best treatment for chronic migraine was a multidisciplinary treatment including biobehavioral and pharmacological approaches. Biobehavioral treatments (BBTs) for chronic pain patients includes therapeutic patient education (TPE) and selfcare, cognitive behavioral interventions, and biobehavioral training (biofeedback, relaxation training, and stress management).
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects diagnosed with chronic migraine
- •Neck, shoulder or spine pain for at least 12 weeks
- •Continuous headache may be chronic daily headache or tension headache
- •Patients having the willing to undergo the treatment
排除标准
- •Patients undergoing physical another therapy treatment in cervical or head areas.
- •Patient with degenerative neurological syndrome or fibromyalgia
- •Patients with severe cognitive impairment
- •Patients undergo any neck, head or shoulder surgical process
结局指标
主要结局
Quality of Life measured by the HIT-6 Questionnaire
时间窗: Baseline
A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral and social environment; the overall condition of a human life.
次要结局
- Sleep Disorders measured by Latineen index score(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
- Medication Adherence scored by a medication calendar(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
- Anxiety measured by EUROQOL score(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
- Disability Evaluation measured by neck disability Index and CF-PDI ( Craniofacial pain and disability inventory)(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
- Quality of Life measured by the HIT-6 Questionnaire(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
- Physical activity measured by IPAQ ( International physical Activity questionnaire)(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
- Pain Threshold measured by algometer(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
- Cervical range of Motion measured by CROM ( cervical range of motion device)(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
- Catastrophization measured by PCS ( Pain Catastrophizing Scale)(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
- Phobic Disorders measured by Chronic Pain self-efficacy Scale, BECK(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
- Self Efficacy measured by Chronic Pain self-efficacy Scale(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
- Kinesiophobia measured by TSK ( Tampa Scale of Kinesiophobia)(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
- Temporal Summation measured by Von Frey filament(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
- Cope (Adaptation, Psychological) measured by CADC questionnaire ( Adaptation of the Chronic Pain self-efficacy Scale) and CAD- R questionnaire(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
- Pain perception outcome assessed by VAS(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
- Pain behaviour assessed by PBQ questionnaire ( Pain behaviour questionnaire)(Baseline , 6 weeks, 2 months, 4 months, 6 months, one year)
研究者
Paula Kindelan
Associate Professor, Universidad autónoma de Madrid
Universidad Autonoma de Madrid