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Not yet recruiting Not applicable NCT07544745

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

No applicable phase (e.g. observational)
Conditions: Chronic Pain

Sponsor: Universidade Federal de Sao Carlos

trial.available_in: БГ
Overview
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.
Description
Introduction: Chronic musculoskeletal pain represents a global health challenge, affecting individuals' quality of life and functional capacity. Approximately 40% of Brazil's adult population suffers from this condition, with women being the most affected. In this context, the biopsychosocial model (BPSM) has gained prominence for integrating biological, psychological, and social factors in pain management. Implementing the biopsychosocial model in specialized healthcare services appears to enhance the assessment and treatment of individuals with chronic pain, improving functional outcomes and quality of life. A key element in this process is the interdisciplinary team, contributing to a more comprehensive assessment and treatment plan. Objective: To determine whether the biopsychosocial model centered on functionality has a greater effect on reducing pain and increasing functionality in the care of individuals with chronic pain than the biopsychosocial model centered on pain, both based on interdisciplinary action. Methods: This is a retrospective cohort study that will use data from medical records of the specialized chronic pain service (Pain Clinic) at the Federal University of São Carlos (UFSCar). Participants with chronic musculoskeletal pain who will undergo a three-month treatment at the clinic will be included. The sample will be divided into two groups: one treated using a pain-centered biopsychosocial model, which involves assessments with various tools to identify key pain-related characteristics, and another with a functionality-centered biopsychosocial model, guided by WHODAS 2.0 and WHOQoL, developing an interdisciplinary therapeutic plan with SMART goals. The outcomes for analyzing the effect on pain and functionality will be pain intensity, pain location (number of body regions affected on the pain map), pain frequency (days per week), pain interference (BPI), and the individual's functional status (Patient-Specific Functional Scale). For the cost-effect-related objectives, metrics of frequency and attendance of individuals to healthcare services will be used. Data will be analyzed using SPSS version 26, with statistical analysis based on the intention-to-treat principle. Mixed linear regression models will also be used. Expected Results: The functionality-centered biopsychosocial model is anticipated to achieve greater pain reduction, improved functional outcomes, and higher treatment adherence compared to the pain-centered model. In addition, the study seeks to provide support for the implementation of more efficient strategies in the treatment of chronic pain, focusing on patient functionality.
Who can participate
Inclusion Criteria: * Aged 18 years or older * Chronic musculoskeletal pain * Have previously undergone unsuccessful pain treatment * Referred from the municipal healthcare system to the Pain Clinic * Undergo treatment at the Pain Clinic for a period of 3 months. Exclusion Criteria: * Uncontrolled diabetes mellitus * Recent postoperative status * Neurological conditions with significant motor impairments * Individuals with oncological conditions * Dementia * Psychopathy * Schizophrenia * Other severe mental disorders * Individuals presenting only acute pain conditions.
Interventions
Pain-Centered Biopsychosocial Model
OTHER
Functionality-Centered Biopsychosocial Model Group
OTHER
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.12.2026
Registry ID
NCT07544745
Source
clinicaltrials.gov
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