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

ConditionChronic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidade Federal de Sao Carlos

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Pain-Centered Biopsychosocial Model

    Other intervention

    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 intervention

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Biopsychosocial Pain-Centered Intervention GroupActive comparator 1 intervention
Group B: Biopsychosocial Functionality-Centered Intervention GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and follow-up assessments throughout the intervention period (up to 3 months)
2

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.

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

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.

Time frame
During the intervention period (up to 3 months)
4

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.

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

Secondary outcomes

1

Number of assessment sessions

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

Time frame
During the intervention period (up to 3 months)
2

Number of treatment sessions

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

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

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.

Time frame
During the intervention period (up to 3 months)
4

Number of assessment instruments applied

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Federal de Sao Carlos

Lead sponsor

Fundação de Amparo à Pesquisa do Estado de São Paulo

Collaborator

This trial is not recruiting at the moment. You can still explore other options: