Effectiveness of a Multimodal Intervention Based on Pain Neuroscience Education, Therapeutic Exercise and Healthy Lifestyle Promotion in Patients With Persistent Musculoskeletal Pain in Primary Care: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 146
- 试验地点
- 5
- 主要终点
- Health-Related Quality of Life
研究概览
简要总结
This multicenter randomized controlled trial aims to evaluate the effectiveness of a multimodal intervention for the active management of persistent musculoskeletal pain in primary care. The intervention combines pain neuroscience education, therapeutic exercise, and the promotion of self-care and healthy lifestyle habits to improve health-related quality of life in adults with persistent nonspecific musculoskeletal pain lasting at least six months.
A total of 146 participants aged 18 to 70 years will be recruited from five primary care centers in the Comunitat Valenciana (Spain) and randomly assigned to either the experimental group or the control group. The primary outcome is health-related quality of life measured using the SF-36 Health Survey. Secondary outcomes include pain intensity, pain catastrophizing, kinesiophobia, central sensitization, emotional symptoms, perceived social support, medication use, and lifestyle-related variables. Assessments will be conducted at baseline, post-intervention, 6 months, and 12 months follow-up.
详细描述
Persistent musculoskeletal pain represents a major public health problem and is one of the most frequent reasons for consultation in primary care. It is associated with reduced quality of life, functional limitations, emotional distress, increased healthcare utilization, and high socioeconomic costs. Contemporary pain science recognizes that persistent pain is a multidimensional experience involving biological, psychological, and social mechanisms, including central sensitization and maladaptive cognitive-emotional processes such as catastrophizing and fear-avoidance behaviors.
Current clinical practice guidelines recommend multimodal and non-pharmacological approaches as first-line management strategies. Pain neuroscience education (PNE) aims to reconceptualize pain by explaining the neurobiological and psychosocial mechanisms involved in persistent pain, thereby reducing perceived threat and maladaptive beliefs. Therapeutic exercise contributes to functional improvement, modulation of central pain mechanisms, and psychological well-being. Additionally, the promotion of self-care strategies and healthy lifestyle habits (including physical activity, sleep hygiene, stress management, and nutritional counseling) may enhance long-term outcomes and patient empowerment.
This study is a multicenter, parallel-group, single-blind randomized controlled trial conducted in five primary care centers in the Comunitat Valenciana (Spain). A total of 146 adults aged 18 to 70 years with nonspecific persistent musculoskeletal pain lasting at least six months will be recruited and randomly allocated to either an experimental group receiving the multimodal intervention or a control group receiving usual care.
The multimodal intervention integrates structured group-based pain neuroscience education sessions, supervised therapeutic exercise, and guidance on self-care and healthy lifestyle habits. The control group will continue to receive standard primary care management.
The primary outcome is health-related quality of life assessed using the SF-36 Health Survey. Secondary outcomes include pain intensity, number of painful areas, pain catastrophizing, kinesiophobia, central sensitization, emotional symptoms, perceived social support, medication consumption, and lifestyle-related variables. Data will be collected at baseline, immediately post-intervention, and at 6- and 12-month follow-ups using the REDCap electronic data capture system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors responsible for statistical analysis will be blinded to group allocation. Due to the nature of the intervention, participants and care providers cannot be blinded.
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
- •Adults aged between 18 and 70 years
- •Diagnosis of nonspecific persistent musculoskeletal pain lasting at least 6 months
- •Receiving care in participating primary care centers
- •Ability to understand study procedures and provide written informed consent
- •Ability to complete self-administered questionnaires
排除标准
- •Specific musculoskeletal pathology requiring specialized treatment (e.g., fracture, inflammatory rheumatic disease, malignancy)
- •Neurological disorders affecting movement or pain perception
- •Severe psychiatric disorders that may interfere with participation
- •Participation in another structured pain management program during the study period
- •Cognitive impairment preventing questionnaire completion
- •Pregnancy (if considered clinically relevant)
研究组 & 干预措施
Multimodal Intervention Group
Participants assigned to the experimental group will receive a structured multimodal intervention delivered in primary care settings. The intervention integrates group-based pain neuroscience education sessions, supervised therapeutic exercise, and guidance on self-care strategies and healthy lifestyle habits. The program aims to promote active coping, improve functional capacity, and enhance health-related quality of life in individuals with persistent musculoskeletal pain.
干预措施: Multimodal Pain Management Program (Behavioral)
Usual Care Group
Participants assigned to the control group will receive usual primary care management for persistent musculoskeletal pain. Usual care may include pharmacological treatment, medical follow-up, and referral to other healthcare services when considered necessary, according to standard clinical practice.
干预措施: Usual Primary Care (Other)
结局指标
主要结局
Health-Related Quality of Life
时间窗: Baseline, immediately post-intervention, 6 months, and 12 months after intervention
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). The SF-36 measures eight health domains and provides physical and mental component summary scores. Higher scores indicate better health-related quality of life.
次要结局
- Pain Intensity(Baseline, immediately post-intervention, 6 months, and 12 months after intervention)
- Number of Painful Body Areas(Baseline, immediately post-intervention, 6 months, and 12 months after intervention)
- Pain Catastrophizing(Baseline, immediately post-intervention, 6 months, and 12 months after intervention)
- Kinesiophobia(Baseline, immediately post-intervention, 6 months, and 12 months after intervention)
- Central Sensitization(Baseline, immediately post-intervention, 6 months, and 12 months after intervention)
- Anxiety Symptoms(Baseline, immediately post-intervention, 6 months, and 12 months after intervention)
- Depressive Symptoms(Baseline, immediately post-intervention, 6 months, and 12 months after intervention)
- Perceived Social Support(Baseline, immediately post-intervention, 6 months, and 12 months after intervention)
- Medication Consumption(Baseline, immediately post-intervention, 6 months, and 12 months after intervention)
- Participant Satisfaction With the Intervention(Immediately post-intervention)