Personological Structure, Cognitive Functions and Central Sensitization in Headache: Obstacles and Resources in the Treatment of Chronic and Episodic Headache.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Neuropsychological assessment
研究概览
简要总结
Headache, in its episodic and chronic forms, cannot be considered solely as an isolated neurological symptom, but as a complex condition of a bio-psycho-social nature. While in the episodic form the painful episodes occur intermittently and have a variable impact on daily life, in the chronic form the disease evolves towards persistent pain, with more significant consequences on personal, social and work functioning. The following study protocol aims to investigate in an integrated manner the neurological, cognitive and psychological mechanisms involved in headache, with particular attention to the differences between episodic and chronic forms. The main objective is to assess the neuropsychological profiles and pain response of patients, monitoring their evolution over a period of approximately six months, considering the impact of central sensitisation, personality structure and any psychopathological comorbidities on pain management and treatment adherence. The protocol adopts a multidimensional approach aimed at optimising therapeutic efficacy and improving patients' quality of life, preventing progression to chronicity.
详细描述
This is an observational, prospective study with two assessment timepoints: baseline (T0) and follow-up at approximately six months (T1). The overall duration of the project is estimated at about three years, including enrollment of all planned participants, completion of follow-up, data analysis and dissemination of results.
The study is conducted at the IRCCS Centro Neurolesi "Bonino-Pulejo" with UTIC P.O. "Piemonte" in Messina, Italy, within the Headache Outpatient Clinic.
The target population consists of adult patients with a diagnosis of chronic or episodic headache referring to the Headache Outpatient Clinic. Sample size was calculated using G*Power 3.1, taking as reference the primary objective of comparing the evolution (baseline vs T1) of main clinical-neuropsychological outcomes between chronic and episodic headache groups. The primary test was modeled as a repeated-measures ANOVA on the group×time interaction (two groups, two measurements), analogous to the interaction component of a linear mixed model.
With a significance level α = 0.05, statistical power 1-β = 0.90, intra-subject correlation r = 0.60 and two measurements, assuming an interaction effect size f = 0.20 and nonsphericity correction ε = 1, the minimum required sample size is N = 56 subjects (28 per group). Taking into account an expected dropout rate of 15%, the required enrollment was increased to N = 64 participants (32 per group), in order to preserve the planned power for the primary analysis.
Inclusion criteria
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age between 18 and 60 years;
- •Diagnosis of chronic or episodic headache;
- •Patients attending the Headache Outpatient Clinic.
排除标准
- •Presence of severe psychiatric and neurological disorders;
- •Presence of oncological diseases in terminal stage
结局指标
主要结局
Neuropsychological assessment
时间窗: 6 months
•Cognitive functions: Brief Cognitive Status Exam (BCSE) and/or Montreal Cognitive Assessment (MoCA)
次要结局
- Central sensitization(6 months)
研究者
Anna Anselmo
Psychologist
IRCCS Centro Neurolesi Bonino Pulejo