Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE)
概览
- 阶段
- 4 期
- 干预措施
- duloxetine
- 疾病 / 适应症
- Chronic Pain
- 发起方
- Wake Forest University Health Sciences
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory (BPI)
- 状态
- 已完成
- 最后更新
- 6个月前
概览
简要总结
The purpose of this research is is to determine if the combination of non-opioid medication (duloxetine) and web-based pain-coping skills training (PCST) is beneficial for individuals with chronic musculoskeletal pain (CMP).
详细描述
With this study, the study team hopes to address two important unanswered questions: (1) Does combination treatment consisting of duloxetine and web-based Cognitive Behavioral Therapy (CBT) optimize treatment outcomes? (2) Would adherence-focused guidance delivered by nurse clinician using motivational interviewing (MI) techniques enhance treatment effectiveness? This study is significant because the study team aims to optimize pain-related treatment outcomes at the primary care level where most patients with pain are managed. Importantly, the use of nurse clinician providing adherence-focused guidance (as opposed to content-focused guidance) on the continued practice (or use) of pain coping skills increases the likelihood that the study's intervention is scalable in the future. Effective, accessible and scalable psychoeducational treatments are needed to manage CMP in real world clinic settings.
研究者
入排标准
入选标准
- •patients at the primary care clinic with daily pain for 3 months or longer affecting the low back, neck, hip, knee or widespread pain;
- •at least moderate in BPI global pain severity
排除标准
- •uncontrolled hypertension (because duloxetine rarely increases blood pressure)
- •active suicidal ideation
- •planned elective surgery during the study period (to avoid the confounding effect of possible complicated post-surgery recovery course on the primary outcome)
- •ongoing unresolved disability claims
- •inflammatory arthritis (e.g., lupus and ankylosing spondylitis)
- •cancer-related musculoskeletal pain
- •pregnancy
- •history of bipolar disorder or schizophrenia
- •narrow angle glaucoma
- •severe renal impairment (creatinine clearance \<30)
研究组 & 干预措施
behavioral intervention, nurse support plus medication
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
干预措施: duloxetine
behavioral intervention, nurse support plus medication
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
干预措施: Web-based Cognitive Behavioral Therapy (CBT)
behavioral intervention, nurse support plus medication
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
干预措施: Nurse-delivered Motivational Interviewing
behavioral intervention plus medication
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
干预措施: duloxetine
behavioral intervention plus medication
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
干预措施: Web-based Cognitive Behavioral Therapy (CBT)
medication only
Subjects randomized to this arm will receive duloxetine only.
干预措施: duloxetine
结局指标
主要结局
Brief Pain Inventory (BPI)
时间窗: week 25 of treatment phase
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Brief Pain Inventory (BPI) Total Pain Severity
时间窗: week 13 of treatment phase
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function(week 25 of treatment phase)
- Patient Health Questionnaire 8-Item Depression Scale (PHQ-8)(week 25 of treatment phase)
- Generalized Anxiety Disorder 7-item Scale (GAD-7)(week 25 of treatment phase)