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ClinicalTrials.gov ID

NCT07461298

Lead Sponsor

Universitat Jaume IOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

146Estimated

Last Update Posted

Mar 10, 2026Actual

Start Date

Jun 2026Estimated

Primary Completion Date

Jan 2028Estimated

Completion Date

Jan 2028Estimated

Official 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

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.

• Chronic Musculoskeletal Pain

• Multimodal Pain Management Program
• Usual Primary Care

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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)

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Universitat Jaume IOTHER

mondejar_mro@gva.es

navarro_roscat@gva.es

llacer_marbos@gva.es