Multimodal Intervention for Persistent Musculoskeletal Pain in Primary Care

NCT07461298 | Not Yet Recruiting

• 2 other identifiers: UJI-DMP-AP-2026OSF-ptwfy
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Musculoskeletal Pain

Keywords

Physical exercise; Patient Care Group; Primary Health Care; Multimodal Intervention; Health-Related Quality of Life; Self-Management; Pain Neuroscience Education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Pain Intensity

  Baseline, immediately post-intervention, 6 months, and 12 months after intervention

• Number of Painful Body Areas

  Baseline, immediately post-intervention, 6 months, and 12 months after intervention

• Pain Catastrophizing

  Baseline, immediately post-intervention, 6 months, and 12 months after intervention

• Kinesiophobia

  Baseline, immediately post-intervention, 6 months, and 12 months after intervention

• Central Sensitization

  Baseline, immediately post-intervention, 6 months, and 12 months after intervention

Study Arms (2)

Multimodal Intervention Group

EXPERIMENTAL

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

Usual Care Group

ACTIVE COMPARATOR

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

Interventions

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.

Multimodal Intervention Group

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.

Usual Care Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (5)

Centro de Salud Marina Española

Elda, Alicante, Spain

Location

Centro de Salud de Villena I

Villena, Alicante, Spain

Location

Centro de Salud Integrado de la Vall d'Uixó

Vall d'Uixó, Castellón, Spain

Location

Centro de Salud de Alginet

Alginet, Valencia, Spain

Location

Centro de Salud de Benifaió

Benifaió, Valencia, Spain

Location

Related Publications (4)

• 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.

  PMID: 29710099 BACKGROUND

• 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.

  PMID: 28087891 BACKGROUND

• 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.

  PMID: 27351541 BACKGROUND

• 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.

  PMID: 28192789 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Victor Ortiz Mallasen

CONTACT

34964387810; ortizv@uji.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 10, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ES (5)