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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal Physiotherapy Intervention | Experimental | Participants will receive a multimodal physiotherapy intervention designed to improve active coping and health-related quality of life in individuals with persistent musculoskeletal pain. The program combines pain neuroscience education sessions with guided therapeutic exercise, delivered by physiotherapists in Primary Care settings. The intervention will be conducted in group sessions over several weeks and will include education on pain mechanisms, movement retraining, and individualized exercise progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic Exercise | Behavioral | 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 Primary Care settings over several weeks. Participants will be encouraged to progressively integrate the exercises and concepts into their daily activities to foster self-management and long-term adherence. |
| Measure | Description | Time Frame |
|---|---|---|
| Health-Related Quality of Life Measured With the 36-Item Short Form Health Survey (SF-36) | 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. | Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Catastrophizing Measured With the Pain Catastrophizing Scale (PCS) | Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), a 13-item questionnaire evaluating rumination, magnification, and helplessness related to pain. Total scores range from 0 to 52, with higher scores indicating greater pain catastrophizing. | Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention. |
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Inclusion Criteria:
- Persistent nonspecific musculoskeletal pain lasting at least 6 months
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victor Ortiz-Mallasen | Contact | 34964387810 | ortizv@uji.es |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Kinesiophobia Assessed Using the Tampa Scale for Kinesiophobia (TSK-11 or TSK-17) | Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK), a validated questionnaire measuring fear of movement and reinjury. Higher scores indicate greater kinesiophobia. | Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention. |
| Central Sensitization Assessed With the Central Sensitization Inventory (CSI) | Central sensitization will be assessed using the Central Sensitization Inventory (CSI), a 25-item questionnaire evaluating symptoms associated with central sensitivity syndromes. Scores range from 0 to 100, with higher scores indicating greater central sensitization. | 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) | Pain intensity will be measured using the 11-point Numerical Rating Scale (NRS), where participants rate their average pain during the previous week from 0 ("no pain") to 10 ("worst imaginable pain"). Higher scores indicate greater pain intensity. | Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention. |
| Treatment Adherence Assessed With a Session Attendance Log | Treatment adherence will be assessed by recording the number of intervention sessions attended by each participant, expressed as the percentage of sessions completed relative to the total scheduled. | During the intervention period |
| Patient Satisfaction Measured With a Likert-Type Satisfaction Questionnaire | Patient satisfaction with the intervention will be assessed using a Likert-type questionnaire (e.g., 0-10 scale or 5-point scale). Higher scores indicate greater satisfaction. | Immediately after the intervention. |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |