Multimodal Physiotherapy Intervention for Active Coping With Persistent Musculoskeletal Pain in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 主要终点
- Health-Related Quality of Life Measured With the 36-Item Short Form Health Survey (SF-36)
研究概览
简要总结
This quasi-experimental, multicenter study aims to evaluate the effectiveness of a multimodal physiotherapy intervention-based on pain neuroscience education and therapeutic exercise-on health-related quality of life in patients with persistent musculoskeletal pain treated in Primary Care.
The study will be conducted in four Primary Care physiotherapy units in the Valencian Community (Spain). A total of at least 68 participants aged 18 to 70 years with nonspecific persistent musculoskeletal pain lasting at least six months will be recruited.
The intervention will consist of a structured multimodal physiotherapy program including educational sessions on pain neuroscience and guided therapeutic exercise. The main outcome will be health-related quality of life, assessed using the SF-36 Health Survey. Secondary outcomes will include pain catastrophizing (Pain Catastrophizing Scale), kinesiophobia (Tampa Scale for Kinesiophobia), and central sensitization (Central Sensitization Inventory), among others.
Data will be collected using the REDCap electronic platform at three time points: baseline (pre-intervention), immediately after the intervention, and six months post-intervention. Statistical analysis will include descriptive statistics, bivariate analyses, and paired comparisons to assess changes over time.
The study seeks to generate evidence on the feasibility and potential effectiveness of implementing a multimodal physiotherapy intervention for active coping with chronic musculoskeletal pain in the context of Primary Care.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Persistent nonspecific musculoskeletal pain lasting at least 6 months
排除标准
- •Oncologic pain.
- •Spinal fracture or surgical intervention within the 12 months prior to the intervention.
- •Cognitive impairment that prevents comprehension of the intervention content (in case of doubt, the Mini-Mental State Examination will be administered, requiring a minimum score of 25).
- •Physical performance deficit that prevents execution of the intervention (minimum requirement: completion of the Timed Up and Go test within the normal time of 10 seconds).
- •Pregnancy.
- •Cauda equina syndrome.
- •Presence of urinary and/or fecal incontinence.
- •Severe psychiatric disorders.
- •Autoimmune diseases.
- •Associated medical conditions that preclude participation in a physical exercise program (e.g., myopathies, neurological diseases with significant functional impairment).
- •Patients undergoing alternative therapies.
- •Patients with an implanted neurostimulator.
结局指标
主要结局
Health-Related Quality of Life Measured With the 36-Item Short Form Health Survey (SF-36)
时间窗: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The instrument provides eight domain scores and a total score, each ranging from 0 to 100. Higher scores indicate better perceived health-related quality of life.
次要结局
- Kinesiophobia Assessed Using the Tampa Scale for Kinesiophobia (TSK-11 or TSK-17)(Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.)
- Central Sensitization Assessed With the Central Sensitization Inventory (CSI)(Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.)
- Pain Intensity Measured Using the Numerical Rating Scale (NRS 0-10)(Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.)
- Treatment Adherence Assessed With a Session Attendance Log(During the intervention period)
- Patient Satisfaction Measured With a Likert-Type Satisfaction Questionnaire(Immediately after the intervention.)
- Pain Catastrophizing Measured With the Pain Catastrophizing Scale (PCS)(Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.)
研究者
Victor Ortiz Mallasen
Assistant Professor of Nursing
Universitat Jaume I