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NCT Number: NCT07461298

Multimodal Intervention for Persistent Musculoskeletal Pain in Primary Care

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Salud Marina Española, Elda, Alicante, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Multimodal Pain Management Program

Behavioral

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.

Usual Primary Care

Other

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.

Primary outcomes

  1. Health-Related Quality of Life

    Time frame: 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 outcomes

  1. Pain Intensity

    Time frame: 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.

  2. Number of Painful Body Areas

    Time frame: Baseline, immediately post-intervention, 6 months, and 12 months after intervention

    Number of body areas with reported pain as self-identified by participants.

  3. Pain Catastrophizing

    Time frame: 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.

  4. Kinesiophobia

    Time frame: 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.

  5. Central Sensitization

    Time frame: 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.

  6. Anxiety Symptoms

    Time frame: 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.

  7. Depressive Symptoms

    Time frame: 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.

  8. Perceived Social Support

    Time frame: 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.

  9. Medication Consumption

    Time frame: Baseline, immediately post-intervention, 6 months, and 12 months after intervention

    Changes in the number and type of medications used for pain management.

  10. Participant Satisfaction With the Intervention

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Victor Ortiz Mallasen

CONTACT

[email protected]

34964387810

Sponsors and collaborators

Lead sponsor

Universitat Jaume I

Other

Registry information

Official study title

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

Acronym: DolorAP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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