Chronic Musculoskeletal Pain
Conditions
Keywords
Physical exercise, Patient Care Group, Primary Health Care, Multimodal Intervention, Health-Related Quality of Life, Self-Management, Pain Neuroscience Education
Brief summary
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.
Detailed description
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. Statistical analyses will include descriptive statistics and inferential analyses to compare within- and between-group differences over time. The study aims to provide robust evidence regarding the effectiveness of a multimodal, biopsychosocial intervention delivered in primary care for the management of persistent musculoskeletal pain.
Interventions
BEHAVIORALMultimodal Pain Management Program
The multimodal program combines pain neuroscience education, therapeutic exercise, and the promotion of self-care and healthy lifestyle habits. Pain neuroscience education focuses on reconceptualizing pain based on contemporary neurophysiological principles. Therapeutic exercise includes supervised physical activity aimed at improving strength, mobility, and functional capacity. The self-care component addresses lifestyle factors such as physical activity, sleep hygiene, stress management, and healthy nutrition.
OTHERUsual Primary Care
Participants in the control group will continue receiving standard primary care treatment as determined by their healthcare providers. This may include medication, medical advice, or referral to other services according to routine clinical practice.
Sponsors
Universitat Jaume I
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either the experimental group receiving the multimodal intervention or the control group receiving usual primary care. The two groups will be followed in parallel throughout the study period, with outcome assessments conducted at baseline, post-intervention, and at 6- and 12-month follow-ups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Baseline, immediately post-intervention, 6 months, and 12 months after intervention | Pain intensity measured using a numerical rating scale (NRS), where higher scores indicate greater pain intensity. |
| Number of Painful Body Areas | Baseline, immediately post-intervention, 6 months, and 12 months after intervention | Number of body areas with reported pain as self-identified by participants. |
| Pain Catastrophizing | Baseline, immediately post-intervention, 6 months, and 12 months after intervention | Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS). Higher scores indicate greater catastrophizing. |
| Kinesiophobia | Baseline, immediately post-intervention, 6 months, and 12 months after intervention | Fear of movement assessed using the Tampa Scale of Kinesiophobia (TSK). Higher scores indicate greater fear of movement. |
| Central Sensitization | Baseline, immediately post-intervention, 6 months, and 12 months after intervention | Central sensitization symptoms assessed using the Central Sensitization Inventory (CSI). Higher scores indicate greater symptom severity. |
| Anxiety Symptoms | Baseline, immediately post-intervention, 6 months, and 12 months after intervention | Anxiety symptoms assessed using the Overall Anxiety Severity and Impairment Scale (OASIS). The OASIS is a 5-item self-report questionnaire measuring the frequency and severity of anxiety symptoms and related functional impairment. Scores range from 0 to 20, with higher scores indicating greater anxiety severity. |
| Depressive Symptoms | Baseline, immediately post-intervention, 6 months, and 12 months after intervention | Depressive symptoms assessed using the Overall Depression Severity and Impairment Scale (ODSIS). The ODSIS is a 5-item self-report questionnaire assessing the frequency and severity of depressive symptoms and associated impairment. Scores range from 0 to 20, with higher scores indicating greater depressive symptom severity. |
| Perceived Social Support | Baseline, immediately post-intervention, 6 months, and 12 months after intervention | Perceived social support assessed using the Duke-UNC Functional Social Support Questionnaire (DUKE-UNC-11). The questionnaire evaluates perceived emotional and instrumental social support. Scores range from 11 to 55, with higher scores indicating greater perceived social support. |
| Medication Consumption | Baseline, immediately post-intervention, 6 months, and 12 months after intervention | Changes in the number and type of medications used for pain management. |
| Participant Satisfaction With the Intervention | Immediately post-intervention | Participant satisfaction assessed using the Client Satisfaction Questionnaire-8 (CSQ-8), an 8-item self-report instrument measuring satisfaction with healthcare services. Total scores range from 8 to 32, with higher scores indicating greater satisfaction with the intervention. |
Countries
Spain
Contacts
CONTACTVictor Ortiz Mallasen
Outcome results
None listed