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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Pain Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Uncontrolled diabetes mellitus
- •Recent postoperative status
- •Neurological conditions with significant motor impairments
- •Individuals with oncological conditions
- •Psychopathy
- •Schizophrenia
- •Other severe mental disorders
- •Individuals presenting only acute pain conditions.
研究组 & 干预措施
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.
干预措施: Pain-Centered Biopsychosocial Model (Other)
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.
干预措施: Functionality-Centered Biopsychosocial Model Group (Other)
结局指标
主要结局
Pain Intensity
时间窗: Baseline and follow-up assessments throughout the intervention period (up to 3 months)
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
时间窗: 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.
Pain Interference
时间窗: During the intervention period (up to 3 months)
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.
Functional Status
时间窗: During the intervention period (up to 3 months)
Measured 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
时间窗: 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
时间窗: 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.
Numeric Rating Scale (NRS)
时间窗: 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.
Brief Pain Inventory (BPI)
时间窗: 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)
时间窗: 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.
次要结局
- 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))
研究者
Melina Nevoeiro Haik
Professor in the Department of Physical Therapy at the Federal University of São Carlos
Universidade Federal de Sao Carlos