Effects of a Hybrid Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic Exercise in Individuals With Chronic Persistent Pain and Depressive Disorder: A Prospective Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pain Intensity (Numering Rating Scale)
研究概览
简要总结
This prospective longitudinal pre-post intervention study aims to evaluate the effects of an 8-week physiotherapy program combining face-to-face and asynchronous tele-rehabilitation sessions in individuals with chronic persistent pain and depressive disorder. The intervention is based on pain neuroscience education and therapeutic exercise. Outcomes include pain intensity, psychosocial factors, adherence to treatment, usability of telemedicine, balance, body awareness, and participants' experiences collected through focus groups.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
盲法说明
No Masking
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Age 45-75 years
- User of AFDA and ASAPME
- Chronic persistent pain
- Written informed consent provided
排除标准
- Severe psychiatric disorders (including schizophrenia)
- Neurological diseases preventing participation
- No internet access
- Mini-Mental State Examination score ≤24
- Acute musculoskeletal disorders
- Rheumatic diseases
- Severe respiratory insufficiency
- Inability to understand Spanish
- Pregnancy, immunosuppression, transplantation or active oncological condition
研究组 & 干预措施
Hybrid Physiotherapy Program
Hybrid Physiotherapy Program consisted of Pain Neuroscience Education and Therapeutic Exercise
干预措施: Hybrid Physiotherapy Program (Other)
结局指标
主要结局
Pain Intensity (Numering Rating Scale)
时间窗: Baseline and Week 8
It is a numerical scale ranging from 1 to 10, where 1 represents the absence of pain and 10 represents the highest intensity.
次要结局
- Pain Catastrophizing Scale(Baseline and Week 8)
- Chronic Pain Coping Questionnaire(Baseline and Week 8)
- Tampa Scale for Kinesiophobia (TSK-11)(Baseline and Week 8)
- Chronic Pain Self-Efficacy Questionnaire(Baseline and Week 8)
- Depression Anxiety Stress Scale (DASS-21)(Baseline and Week 8)
- Fear Avoidance Beliefs Questionnaire (FABQ)(Baseline and Week 8)
- Clinical Global Impression Scale (CGI)(Baseline and Week 8)
- Qualitative outcomes from focus groups(Week 8)
研究者
Sandra Calvo Carrión
Phd. Clinical professor
Instituto de Investigación Sanitaria Aragón
研究点 (1)
标识符
- NCT 编号
- NCT07764848
- 其他研究编号
- UZ-USJ_Pain-Mental Healht-Phys
日期
- 首次提交
- (上个月)
- 首次发布
- (上个月)
- 主要完成日期
- (4个月前)
- 研究完成日期
- (4个月前)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否