Chronic PainNCT07544745
Effects of Biopsychosocial Models Based on Pain or Functionality in the Treatment of Chronic Musculoskeletal Pain
A study testing Pain-Centered Biopsychosocial Model and Functionality-Centered Biopsychosocial Model Group in people with Chronic Pain, run by Universidade Federal de Sao Carlos.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Pain-Centered Biopsychosocial Model and Functionality-Centered Biopsychosocial Model Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Uncontrolled diabetes mellitus
- Recent postoperative status
- Neurological conditions with significant motor impairments
- Individuals with oncological conditions
- Dementia
- Psychopathy
Show all 9Show fewer
- Schizophrenia
- Other severe mental disorders
- Individuals presenting only acute pain conditions.
About this study
Official 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
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?
Read more
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Pain-Centered Biopsychosocial Model, Functionality-Centered Biopsychosocial Model Group
- Keywords
- chronic pain, interdisciplinary healthcare team, cost-effectiveness, biopsychosocial model
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain-Centered Biopsychosocial ModelOther
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 GroupOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Functionality-Centered Biopsychosocial Model Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the intervention period (up to 3 months)
Secondary outcomes (5)
Number of assessment sessions
The total number of sessions conducted for the purpose of evaluating the patient will be quantified.
Measured: 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.
Measured: 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.
Measured: During the intervention period (up to 3 months)
Number of assessment instruments applied
All additional instruments used to evaluate the patient will be recorded.
Measured: 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.
Measured: During the intervention period (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Melina Nevoeiro Haik, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544745
- Sponsor's protocol ID
- BPS-FUNC-DCM-2026
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07544745
- Acronym / sponsor ID
- BPS-FUNC-DCM-2026
- Conditions
- Chronic Pain
- Keywords
- chronic pain, interdisciplinary healthcare team, cost-effectiveness, biopsychosocial model
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biopsychosocial Pain-Centered Intervention Group | Active comparator | Other: Pain-Centered Biopsychosocial ModelParticipants 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. |
| Biopsychosocial Functionality-Centered Intervention Group | Active comparator | Other: Functionality-Centered Biopsychosocial Model GroupParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Uncontrolled diabetes mellitus
- Recent postoperative status
- Neurological conditions with significant motor impairments
- Individuals with oncological conditions
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain-Centered Biopsychosocial ModelParticipants 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. | Other | Biopsychosocial Pain-Centered Intervention Group |
| Functionality-Centered Biopsychosocial Model GroupParticipants 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. | Other | Biopsychosocial Functionality-Centered Intervention Group |
Primary outcome
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.
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.
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.
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.
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.
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.
5 secondary outcomes
Number of assessment sessions
Time frame: During the intervention period (up to 3 months)
Number of treatment sessions
Time frame: During the intervention period (up to 3 months)
Number of missed appointments
Time frame: During the intervention period (up to 3 months)
Number of assessment instruments applied
Time frame: During the intervention period (up to 3 months)
Weekly frequency of medication intake for pain control
Time frame: During the intervention period (up to 3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pain-Centered Biopsychosocial Model and Functionality-Centered Biopsychosocial Model Group in people with Chronic Pain, run by Universidade Federal de Sao Carlos.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) (time frame: Baseline and follow-up assessments throughout the intervention period (up to 3 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.