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

NCT07544745 | Not Yet Recruiting

• 1 other identifier: BPS-FUNC-DCM-2026
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Pain

Keywords

chronic pain; interdisciplinary healthcare team; cost-effectiveness; biopsychosocial model

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

Secondary Outcomes (5)

• Number of assessment sessions

  During the intervention period (up to 3 months)

• Number of treatment sessions

  During the intervention period (up to 3 months)

• Number of missed appointments

  During the intervention period (up to 3 months)

• Number of assessment instruments applied

  During the intervention period (up to 3 months)

• Weekly frequency of medication intake for pain control

  During the intervention period (up to 3 months)

Study Arms (2)

Biopsychosocial Pain-Centered Intervention Group

ACTIVE COMPARATOR

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

Biopsychosocial Functionality-Centered Intervention Group

ACTIVE COMPARATOR

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

Interventions

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.

Biopsychosocial Pain-Centered Intervention Group

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.

Biopsychosocial Functionality-Centered Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in the Department of Physical Therapy at the Federal University of São Carlos

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share