Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory (BPI)
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The project manager, who is blinded of treatment group assignment, has the primary responsibility of collecting outcome data throughout the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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)
- •current use of duloxetine
- •current use of any of the following medications (to avoid adverse drug-to-drug interactions): tricyclic antidepressant > 25 mg daily dose, monoamine oxidase inhibitors, fluoxetine, sertraline, paroxetine, citalopram, escitalopram, venlafaxine, milnacipran, mirtazapine, gabapentin or aripiprazole, serotonin precursors (e.g., tryptophan), and strong CYP1A2 inhibitors (e.g., ciprofloxacin, other fluoroquinolones, fluvoxamine and verapamil)
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 (Drug)
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)
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 (Other)
behavioral intervention plus medication
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
干预措施: duloxetine (Drug)
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) (Behavioral)
medication only
Subjects randomized to this arm will receive duloxetine only.
干预措施: duloxetine (Drug)
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)