Multidisciplinary Intervention in Patients With Non-Cancer Chronic Pain in a Primary Care Center: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Health-Related Quality of Life Measured With the EQ-5D-5L
研究概览
简要总结
Introduction:
Non-cancer chronic pain (NCCP) persists beyond the injury that caused it, affecting approximately 20% of the global population (around 1.6 billion people) and 17-18% in Spain (about 8 million people). Its treatment is complex and often insufficient, highlighting the need for an integrated, multimodal, multidisciplinary approach coordinated between primary and hospital care.
Objective:
To evaluate the effectiveness of a multidisciplinary intervention program combining pain neuroscience education, therapeutic physical exercise, and promotion of healthy habits, aiming to improve health-related quality of life in individuals with NCCP at the Benicàssim Health Center.
Methodology:
This is a quasi-experimental, before-and-after pilot study, non-randomized, without a control group, using a convenience sample of 12 participants. Sociodemographic, health-related, and clinical variables will be measured, including health-related quality of life, central sensitization, kinesiophobia, catastrophizing, pain level, body mass index, sleep quality, perceived social support, anxiety, and depression. Measurements will be taken before the program, at completion, and at 3 months.
The intervention is a 6-week group program with 17 sessions, combining pain neuroscience education, individualized therapeutic exercises, and promotion of healthy habits. Data will be analyzed using SPSS v.29 with a significance level of p<0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged between 18 and 79 years.
- •Individuals diagnosed with non-cancer chronic pain lasting more than 3 months.
排除标准
- •Individuals with pain of oncologic origin.
- •Individuals who have experienced a fracture or undergone surgery within the past year.
- •Pregnant women.
- •Individuals without adequate understanding of the Spanish language.
- •Individuals with cognitive impairment that prevents them from performing the program's interventions.
- •Individuals with physical performance deficits that prevent them from carrying out the program's activities.
- •Individuals with urinary and/or fecal incontinence.
结局指标
主要结局
Health-Related Quality of Life Measured With the EQ-5D-5L
时间窗: Baseline, immediately after the 6-week program, and 3 months after intervention completion.
Health-related quality of life will be assessed using the EQ-5D-5L questionnaire. The EQ-5D-5L index value typically ranges from less than 0 (worse than death) to 1.00 (full health). Higher scores indicate better health-related quality of life. The EQ-VAS ranges from 0 (worst imaginable health) to 100 (best imaginable health).
次要结局
- Pain Intensity Measured With the Visual Analog Scale (VAS)(Baseline, post-intervention, 3 months.)
- Central Sensitization Assessed With the Central Sensitization Inventory (CSI)(Baseline, immediately after the intervention, and 3 months after intervention completion.)
- Kinesiophobia Measured With the Tampa Scale for Kinesiophobia (TSK-11)(Baseline, immediately after the intervention, and 3 months after intervention completion.)
- Pain Catastrophizing Measured With the Pain Catastrophizing Scale (PCS)(Baseline, immediately after the intervention, and 3 months after intervention completion.)
- Sleep Quality Assessed With the Pittsburgh Sleep Quality Index (PSQI)(Baseline, immediately after the intervention, and 3 months after intervention completion.)
- Anxiety and Depression Assessed With the Hospital Anxiety and Depression Scale (HADS)(Baseline, immediately after the intervention, and 3 months after intervention completion.)
- Perceived Social Support Measured With the Duke-UNC Functional Social Support Questionnaire(Baseline, immediately after the intervention, and 3 months after intervention completion.)
研究者
Victor Ortiz Mallasen
Assistant Professor of Nursing
Universitat Jaume I