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

Официальное название

Effects of a Biopsychosocial Model Centered on Functionality in the Care of Individuals With Chronic Musculoskeletal Pain in a Specialized Health Service: A Retrospective Cohort Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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
• Другое 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 Ne

Первичные конечные точки

• Numeric Rating Scale (NRS) [Срок оценки: Baseline and follow-up assessments throughout the intervention period (up to 3 months)]
• Pain Location [Срок оценки: During the intervention period (up to 3 months)]
• Brief Pain Inventory (BPI) [Срок оценки: During the intervention period (up to 3 months)]
• Patient-Specific Functional Scale (PSFS) [Срок оценки: During the intervention period (up to 3 months)]
• Pain improvement and/or worsening [Срок оценки: During the intervention period (up to 3 months)]
• Number of psychotherapy sessions [Срок оценки: During the intervention period (up to 3 months)]

Вторичные конечные точки (5)

• Number of assessment sessions [Срок оценки: During the intervention period (up to 3 months)]
• Number of treatment sessions [Срок оценки: During the intervention period (up to 3 months)]
• Number of missed appointments [Срок оценки: During the intervention period (up to 3 months)]
• Number of assessment instruments applied [Срок оценки: During the intervention period (up to 3 months)]
• Weekly frequency of medication intake for pain control [Срок оценки: During the intervention period (up to 3 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07544745 · BPS-FUNC-DCM-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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