Multimodal Physiotherapy and Pain Coping in Primary Care

Официальное название

Multimodal Physiotherapy Intervention for Active Coping With Persistent Musculoskeletal Pain in Primary Care

Обзор

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.

Вмешательства

• Поведенческое Multimodal Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic Exercise
  The intervention consists of a multimodal physiotherapy program designed to promote active coping and improve health-related quality of life in patients with persistent musculoskeletal pain. It includes educational sessions on pain neuroscience aimed at reconceptualizing pain and reducing maladaptive beliefs, combined with supervised therapeutic exercise focused on mobility, strength, and functional recovery. The program will be delivered in small group sessions by trained physiotherapists in Pr

Первичные конечные точки

• Health-Related Quality of Life Measured With the 36-Item Short Form Health Survey (SF-36) [Срок оценки: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.]

Вторичные конечные точки (6)

• Pain Catastrophizing Measured With the Pain Catastrophizing Scale (PCS) [Срок оценки: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.]
• Kinesiophobia Assessed Using the Tampa Scale for Kinesiophobia (TSK-11 or TSK-17) [Срок оценки: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.]
• Central Sensitization Assessed With the Central Sensitization Inventory (CSI) [Срок оценки: 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) [Срок оценки: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.]
• Treatment Adherence Assessed With a Session Attendance Log [Срок оценки: During the intervention period]
• Patient Satisfaction Measured With a Likert-Type Satisfaction Questionnaire [Срок оценки: Immediately after the intervention.]

Критерии участия

Критерии включения

\- Persistent nonspecific musculoskeletal pain lasting at least 6 months

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07299929 · DC-GVA-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗