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Effects of Biopsychosocial Models Based on Pain or Functionality in the Treatment of Chronic Musculoskeletal Pain

NCT07544745 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-29

No results posted yet for this study

Summary

The objective of this study is to evaluate whether a functionality-centered biopsychosocial model can improve clinical outcomes in the care of individuals with chronic musculoskeletal pain treated in a specialized healthcare service. The main questions it aims to answer are:

Does the functionality-centered biopsychosocial model lead to a greater reduction in pain intensity compared to the pain-centered biopsychosocial model?

Does the functionality-centered biopsychosocial model lead to greater improvement in functionality and performance of daily activities in individuals with chronic pain?

Researchers will compare individuals treated using a functionality-centered biopsychosocial model with individuals treated using a pain-centered biopsychosocial model to determine whether the functionality-centered model results in better clinical outcomes and greater treatment adherence.

Participants will:

Attend weekly interdisciplinary appointments in a specialized chronic pain service for approximately 3 months.

Undergo clinical assessments recorded in their medical records, including measures of pain intensity, pain interference, and functional status.

Participate in interdisciplinary therapeutic interventions based on the biopsychosocial model, which may include pain neuroscience education, therapeutic exercises, behavioral strategies, and the establishment of functional goals.

Conditions

Interventions

OTHER

Pain-Centered Biopsychosocial Model

Participants receive a biopsychosocial intervention centered on pain. The process begins with a comprehensive pain-focused assessment, including pain intensity, location, frequency, and psychosocial factors (e.g., fear of movement, catastrophizing, anxiety, depression, and sleep quality). Based on this evaluation, treatment goals are collaboratively defined with emphasis on pain reduction and pain-related outcomes. Participants receive Pain Neuroscience Education and an individualized treatment plan developed by an interdisciplinary team.

OTHER

Functionality-Centered Biopsychosocial Model Group

Participants receive a biopsychosocial intervention centered on functionality. After a comprehensive assessment, including measures of disability and quality of life, the most affected functional domains are identified using WHODAS 2.0. These domains guide the establishment of individualized SMART goals in collaboration with the patient. The interdisciplinary team develops a personalized treatment plan targeting improvement in functional performance and participation in daily activities. Pain Neuroscience Education is also included as part of the intervention, integrated according to the patient's needs.

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Universidade Federal de Sao Carlos

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-06-30
Completion
2026-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07544745 on ClinicalTrials.gov