Multimodal Intervention for Persistent Musculoskeletal Pain in Primary Care (DolorAP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Musculoskeletal Pain
• Intervention / Treatment: Behavioral: Multimodal Pain Management Program; Other: Usual Primary Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victor Ortiz Mallasen; Phone Number: 34964387810; Email: ortizv@uji.es

Study Locations

• Spain
  • Alicante
    • Elda, Alicante, Spain
      • Centro de Salud Marina Española
      • Contact: Cristina Cuadrado Baca; Email: cuadrado_cri@gva.es
    • Villena, Alicante, Spain
      • Centro de Salud de Villena I
      • Contact: Mª Rosario Mondéjar Martín; Email: mondejar_mro@gva.es
  • Castellón
    • Vall d'Uixó, Castellón, Spain
      • Centro de Salud Integrado de la Vall d'Uixó
      • Contact: Marta Masiá Ramos; Email: masia_marram@gva.es
  • Valencia
    • Alginet, Valencia, Spain
      • Centro de Salud de Alginet
      • Contact: Rosa Navarro Catalá; Email: navarro_roscat@gva.es
    • Benifaió, Valencia, Spain
      • Centro de Salud de Benifaió
      • Contact: Mª José Llácer Bosch; Email: llacer_marbos@gva.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Multimodal 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.
Active Comparator: 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.	Other: Usual 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-Related Quality of Life	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.	Baseline, immediately post-intervention, 6 months, and 12 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Pain intensity measured using a numerical rating scale (NRS), where higher scores indicate greater pain intensity.	Baseline, immediately post-intervention, 6 months, and 12 months after intervention
Number of Painful Body Areas	Number of body areas with reported pain as self-identified by participants.	Baseline, immediately post-intervention, 6 months, and 12 months after intervention
Pain Catastrophizing	Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS). Higher scores indicate greater catastrophizing.	Baseline, immediately post-intervention, 6 months, and 12 months after intervention
Kinesiophobia	Fear of movement assessed using the Tampa Scale of Kinesiophobia (TSK). Higher scores indicate greater fear of movement.	Baseline, immediately post-intervention, 6 months, and 12 months after intervention
Central Sensitization	Central sensitization symptoms assessed using the Central Sensitization Inventory (CSI). Higher scores indicate greater symptom severity.	Baseline, immediately post-intervention, 6 months, and 12 months after intervention
Anxiety Symptoms	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.	Baseline, immediately post-intervention, 6 months, and 12 months after intervention
Depressive Symptoms	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.	Baseline, immediately post-intervention, 6 months, and 12 months after intervention
Perceived Social Support	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.	Baseline, immediately post-intervention, 6 months, and 12 months after intervention
Medication Consumption	Changes in the number and type of medications used for pain management.	Baseline, immediately post-intervention, 6 months, and 12 months after intervention
Participant Satisfaction With the 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.	Immediately post-intervention

Collaborators and Investigators

• Sponsor: Universitat Jaume I

Publications and helpful links

General Publications

• Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
• Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
• Malfliet A, Kregel J, Coppieters I, De Pauw R, Meeus M, Roussel N, Cagnie B, Danneels L, Nijs J. Effect of Pain Neuroscience Education Combined With Cognition-Targeted Motor Control Training on Chronic Spinal Pain: A Randomized Clinical Trial. JAMA Neurol. 2018 Jul 1;75(7):808-817. doi: 10.1001/jamaneurol.2018.0492.
• Geneen LJ, Moore RA, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2017 Jan 14;1(1):CD011279. doi: 10.1002/14651858.CD011279.pub2.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Primary Health Care; Self-Management; Physical exercise; Pain Neuroscience Education; Health-Related Quality of Life; Multimodal Intervention; Patient Care Group
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: UJI-DMP-AP-2026; OSF-ptwfy (Other Identifier: Open Science Framework)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) underlying the results reported in publications will be made available upon reasonable request. Data will be shared after publication of the primary results and will include variables necessary to reproduce the analyses. All shared data will be fully anonymized in accordance with applicable data protection regulations (including GDPR). Requests must include a methodologically sound research proposal and will require approval by the principal investigator and the corresponding ethics committee where applicable.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No