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

Official title

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

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.

Detailed 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.

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
• 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 Ne

Primary outcome measures

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

Secondary outcome measures (5)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07544745 · BPS-FUNC-DCM-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗