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

Sponsor
Universidade Federal de Sao Carlos
Study ID
NCT07544745
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Apr 22, 2026
Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Numeric Rating Scale (NRS) [ Time Frame: Baseline and follow-up assessments throughout the intervention period (up to 3 months) ]

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