Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07544745

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain-Centered Biopsychosocial Model

Other

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.

Functionality-Centered Biopsychosocial Model Group

Other

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.

Primary outcomes

  1. Numeric Rating Scale (NRS)

    Time frame: Baseline and follow-up assessments throughout the intervention period (up to 3 months)

    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.

  2. Pain Location

    Time frame: During the intervention period (up to 3 months)

    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.

  3. Brief Pain Inventory (BPI)

    Time frame: During the intervention period (up to 3 months)

    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.

  4. Patient-Specific Functional Scale (PSFS)

    Time frame: During the intervention period (up to 3 months)

    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.

  5. Pain improvement and/or worsening

    Time frame: During the intervention period (up to 3 months)

    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.

  6. Number of psychotherapy sessions

    Time frame: During the intervention period (up to 3 months)

    Participants' attendance in psychotherapy will be recorded, and the total number of sessions attended will also be reported.

Secondary outcomes

  1. Number of assessment sessions

    Time frame: During the intervention period (up to 3 months)

    The total number of sessions conducted for the purpose of evaluating the patient will be quantified.

  2. Number of treatment sessions

    Time frame: During the intervention period (up to 3 months)

    The total number of treatment sessions carried out during the 3-month treatment period will be quantified.

  3. Number of missed appointments

    Time frame: During the intervention period (up to 3 months)

    The number of absences and/or missed appointments will be recorded, as well as the reason why the session did not take place.

  4. Number of assessment instruments applied

    Time frame: During the intervention period (up to 3 months)

    All additional instruments used to evaluate the patient will be recorded.

  5. Weekly frequency of medication intake for pain control

    Time frame: During the intervention period (up to 3 months)

    At each weekly session, information will be collected regarding medication intake on the days preceding the appointment.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Sao Carlos

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.