Chronic Musculoskeletal Pain
Conditions
Brief summary
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.
Interventions
BEHAVIORALMultimodal 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 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.
Sponsors
Universitat Jaume I
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
\- Persistent nonspecific musculoskeletal pain lasting at least 6 months
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life Measured With the 36-Item Short Form Health Survey (SF-36) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Central Sensitization Assessed With the Central Sensitization Inventory (CSI) | Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention. | 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. |
| Pain Catastrophizing Measured With the Pain Catastrophizing Scale (PCS) | Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention. | 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. |
| Treatment Adherence Assessed With a Session Attendance Log | During the intervention period | 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. |
| Patient Satisfaction Measured With a Likert-Type Satisfaction Questionnaire | Immediately after the intervention. | 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. |
| 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. | 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. |
Contacts
Primary ContactVictor Ortiz-Mallasen
Outcome results
None listed