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临床试验/NCT04870957
NCT04870957已完成4 期

University of Michigan Mechanistic Research Center -The Back Pain Consortium Research Program

University of Michigan1 个研究点 分布在 1 个国家目标入组 494 人开始时间: 2021年6月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
494
试验地点
1
主要终点
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a Between Week 6 (T2) to Week 15 (T3)

研究概览

简要总结

This study is being completed to better understand who benefits from different chronic pain treatments and how these treatments work.

This study will include a four week run-in period for all cLBP participants. After completing the PainGuide (online or smart phone accessible website) run-in period, participants will be assessed using either the light or light plus deep phenotyping assessment battery and those who minimal or modest improvement in their pain (based on PGIC) will be randomized to one of four 8-week treatments (mindfulness-based stress reduction (MBSR), physical therapy (PT) and exercise, acupressure self-management, or duloxetine).

In addition, participants will complete study visits including physical exams, complete surveys, provide samples (blood,saliva, etc.), wear an electronic wrist device at certain times, and have Magnetic resonance imaging (MRIs) during the study.

Following one of the 4 treatments (8 weeks) if participants have a certain level of pain (that meets eligibility for more treatment) they will be then randomized to complete one of the 3 treatments that was not already assigned to them.

The study hypothesizes the following:

that this interventional response phenotyping can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based interventions for chronic lower back pain (cLBP).

详细描述

In addition, the following mechanistic hypothesis and Aims are included:

Mindfulness-Based Stress Reduction:

Aim 2: the study predicts that patients with chronic low back pain (cLBP) will preferentially respond to this therapy if PROs indicate higher levels of pain catastrophizing, as measured by the Pain Catastrophizing Scale, or lower scores on the Experiences Questionnaire.

Aim 3: the study hypothesizes that cLBP patients with decreased activation in response to pain in the subgenual anterior cingulate cortex (sgACC) and Prefrontal Cortex and increased activation in somatosensory cortex (S1) and thalamus will respond preferentially to MBSR.

Physical Therapy (PT) and Exercise

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

MBSR (mindfulness-based stress reduction)

Experimental

Participants receiving MBSR during Treatment 1 or 2.

干预措施: MBSR (Behavioral)

MBSR (mindfulness-based stress reduction)

Experimental

Participants receiving MBSR during Treatment 1 or 2.

干预措施: Pro-Diary monitor (Device)

PT and exercise

Experimental

Participants receiving PT during Treatment 1 or 2.

干预措施: PT and exercise (Behavioral)

PT and exercise

Experimental

Participants receiving PT during Treatment 1 or 2.

干预措施: Pro-Diary monitor (Device)

Acupressure

Experimental

Participants receiving Acupresure during Treatment 1 or 2.

干预措施: Self -administered acupressure (Device)

Acupressure

Experimental

Participants receiving Acupresure during Treatment 1 or 2.

干预措施: Pro-Diary monitor (Device)

Duloxetine

Experimental

Participants receiving Duloxetine during Treatment 1 or 2.

干预措施: Duloxetine (Drug)

Duloxetine

Experimental

Participants receiving Duloxetine during Treatment 1 or 2.

干预措施: Pro-Diary monitor (Device)

Run-In

Experimental

Pre-treatment run-in period with access to the PainGuide self management platform.

干预措施: PainGuide (Behavioral)

Run-In

Experimental

Pre-treatment run-in period with access to the PainGuide self management platform.

干预措施: Pro-Diary monitor (Device)

结局指标

主要结局

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a Between Week 6 (T2) to Week 15 (T3)

时间窗: week 6 (T2), week 15 (T3)

The PROMIS pain interference consists of 4 questions on a Likert scale ranging from 'Not at all" (1) to "Very much" (5). Total scores are between 4 and 20, with higher scores indicating increased pain interference.

次要结局

  • Change in the Pain, Enjoyment, and General Activity Scale (PEG) From Week 6 (T2) to Week 15 (T3)(week 6 (T2), week 15 (T3))
  • Patient Global Impression of Change (PGIC) From Week 6 (T2) to Week 15 (T3)(week 15 (T3))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Afton Hassett, Psy.D.

Associate Professor of Anesthesiology

University of Michigan

研究点 (1)

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