About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or older
Chronic musculoskeletal pain
Have previously undergone unsuccessful pain treatment
Referred from the municipal healthcare system to the Pain Clinic
Disqualifiers
Uncontrolled diabetes mellitus
Recent postoperative status
Neurological conditions with significant motor impairments
Individuals with oncological conditions
Trial design
Parallel
Treatments tested in this trial
Pain-Centered Biopsychosocial Model
Other interventionParticipants 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 interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Number of assessment sessions
The total number of sessions conducted for the purpose of evaluating the patient will be quantified.
Number of treatment sessions
The total number of treatment sessions carried out during the 3-month treatment period will be quantified.
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.
Number of assessment instruments applied
All additional instruments used to evaluate the patient will be recorded.
Locations
Sponsors and contacts
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Universidade Federal de Sao Carlos
Lead sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator
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