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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Pain-Centered Biopsychosocial Model; Other: Functionality-Centered Biopsychosocial Model Group

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Biopsychosocial Pain-Centered Intervention Group; Participants undergo an initial assessment focused on pain, including clinical history, pain characteristics, and psychosocial factors. Standardized instruments are used to evaluate pain intensity, impact, fear of movement, catastrophizing, central sensitization, sleep quality, anxiety, depression, and functional status.	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.
Active Comparator: Biopsychosocial Functionality-Centered Intervention Group; Participants undergo an initial assessment focused on functionality, including clinical history and functional evaluation. In addition to pain-related measures, instruments assessing disability and quality of life (WHODAS 2.0 and WHOQOL) are applied. The most affected functional domains are identified and prioritized, guiding individualized goal-setting (SMART goals) and treatment planning. The interdisciplinary team develops a personalized intervention targeting functional improvement, with Pain Neuroscience Education integrated as appropriate.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Location	Assessed as part of the Brief Pain Inventory (BPI), which includes a body map where the individual marks all areas in which they feel pain. The greater the number of marked areas, the more widespread the participant's pain.	During the intervention period (up to 3 months)
Pain improvement and/or worsening	Patient-reported factors that influence pain will be analyzed by categorizing responses to the questions "What improves your pain?" and "What worsens your pain?" into biological, psychological, and social domains. Responses will be quantified within each domain, and the number of events (frequency) related to improvement or worsening in each domain will be reported.	During the intervention period (up to 3 months)
Number of psychotherapy sessions	Participants' attendance in psychotherapy will be recorded, and the total number of sessions attended will also be reported.	During the intervention period (up to 3 months)
Numeric Rating Scale (NRS)	Pain intensity is assessed using the Numeric Rating Scale (NRS), an instrument that quantifies the individual's pain sensation from zero to ten, where zero represents no pain and ten represents the worst pain ever experienced by the individual. Higher scores indicate greater pain intensity, while lower scores indicate reduced pain intensity.	Baseline and follow-up assessments throughout the intervention period (up to 3 months)
Brief Pain Inventory (BPI)	Pain interference will be assessed using the Brief Pain Inventory (BPI), through seven items scored from zero to ten that evaluate how pain interferes with daily life. Higher scores indicate greater interference of pain in daily activities, while lower scores indicate less impairment.	During the intervention period (up to 3 months)
Patient-Specific Functional Scale (PSFS)	Functional status will be assessed using the Patient-Specific Functional Scale (PSFS). Participants will list three or more activities of daily living that are important to them and that, due to chronic pain, they are no longer able to perform as before. After listing them, participants will assign a score from zero to ten for each activity. Scores closer to zero indicate greater difficulty in performing the activity, while scores closer to ten indicate less impact of chronic pain on functional status.	During the intervention period (up to 3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of assessment sessions	The total number of sessions conducted for the purpose of evaluating the patient will be quantified.	During the intervention period (up to 3 months)
Number of treatment sessions	The total number of treatment sessions carried out during the 3-month treatment period will be quantified.	During the intervention period (up to 3 months)
Number of missed appointments	The number of absences and/or missed appointments will be recorded, as well as the reason why the session did not take place.	During the intervention period (up to 3 months)
Number of assessment instruments applied	All additional instruments used to evaluate the patient will be recorded.	During the intervention period (up to 3 months)
Weekly frequency of medication intake for pain control	At each weekly session, information will be collected regarding medication intake on the days preceding the appointment.	During the intervention period (up to 3 months)

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; cost-effectiveness; biopsychosocial model; interdisciplinary healthcare team
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: BPS-FUNC-DCM-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to participant-level data will not be publicly shared due to confidentiality and privacy concerns. However, de-identified (masked) data may be made available upon reasonable request to the corresponding investigator. All shared data will have any information that could potentially identify participants removed or anonymized to ensure protection of personal and sensitive information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No