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治疗腰痛患者的负面影响 (TNA-LBP)

2026年8月27日 更新者：Ajay Wasan, MD, Msc

治疗慢性腰痛负面影响的概念研究证明

本研究将检查抗抑郁药、物理疗法以及两者的结合如何影响慢性腰痛患者的疼痛、功能和抑郁结果。

研究概览

地位

完全的

条件

干预/治疗

详细说明

大约有 2000 万美国人受到慢性腰痛和抑郁和焦虑等负面情绪状态的影响。 在腰痛患者中，这些负面状态都与较高的疼痛强度、较低的疼痛耐受性、更多的止痛药使用、较差的疼痛治疗反应以及较高水平的精神疾病合并症有关。 为了改善腰痛患者的这些结果，重要的是实施多种方法，重点是治疗对疼痛管理的负面影响，而不是单独使用阿片类药物。

抗抑郁药 (AD) 和基于恐惧回避的物理疗法 (EFAR) 已分别证明是有前途的疼痛管理方法。 在这项研究中，将探索和实施 AD、EFAR 以及两种疗法的联合疗法，以研究它们在改善疼痛、功能、抑郁和焦虑方面的有效性。 关键的创新是测试一种新的有效的多模式治疗，它可以帮助控制疼痛，并解决负面影响。

研究类型

介入性

注册 (实际的)

308

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Massachusetts
      • Chestnut Hill、Massachusetts、美国、02467
        • BWH Pain Management Center
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15206
        • UPMC Pain Medicine At Centre Commons

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 18-75岁
  • 疼痛持续时间 > 6 个月
  • 必须满足使用 PROMIS 2 项认知筛选器 (>3) 的认知功能最低标准
  • 平均疼痛评分 > 3/10，腰痛是主要疼痛部位
  • CLBP 会议魁北克特别工作组分类系统类别 I-III（从仅轴向疼痛到没有神经系统体征的膝关节以外的放射痛）。 与感觉丧失相关的持续根性疼痛在不手术的情况下具有很高的治疗抵抗力
  • 先前腰椎 X 光检查的证据，以排除危险信号，例如感染、肿瘤或骨折
  • 必须在第一次研究访问时满足高负面影响的标准：PHQ-4（也称为 PHQ-2 + GAD-2）至少有 5 个。 高于此水平的分数与共病重度抑郁症或广泛性焦虑症诊断高度相关
  • 从 UPMC、布莱根妇女医院或罗切斯特梅奥诊所获得电子病历。
  • 对于服用阿片类药物的人（阿片类药物亚组），参与者必须在入组前至少连续 3 个月服用阿片类药物。 患者必须服用阿片类药物至少三个月，每天服用或在一周内间歇服用。 调查人员将包括那些服用强阿片类药物（如羟考酮）和弱阿片类药物（如曲马多）的人。
  • 受试者必须同意在研究期间不能增加阿片类药物
  • 对于服用阿片类药物的人，PI 在过去一年中使用烟草、酒精、处方药和其他物质工具 (TAPS) 和尿液毒理学筛查确定没有活性物质使用障碍。 例外情况是在宾夕法尼亚州或明尼苏达州使用烟草、医用大麻、在波士顿工厂使用休闲或医用大麻，或轻度处方阿片类药物使用障碍，例如阿片类药物滥用
  • 没有急性自杀倾向或主要思想障碍史（如躁狂症或精神病）。 这将在研究开始时进行评估，其中还将包括对 EPIC/EMR 历史的回顾
  • 必须拥有可以发送和接收短信和访问互联网的移动设备或平板电脑

排除标准：

  • 过去六个月内做过背部手术
  • 在职员工的赔偿或诉讼索赔
  • 入组后 2 周内接受新的疼痛和/或精神治疗
  • 打算在研究期间增加新的或增加疼痛治疗，例如背部手术、神经阻滞手术或药物治疗
  • 打算在研究的前 4 个月内增加新的精神科治疗
  • 任何被判断为干扰试验的临床不稳定的全身性疾病
  • 心脏、神经系统或呼吸系统疾病的病史，根据研究者的判断，由于呼吸抑制的可能性增加而排除参与研究
  • 非卧床状态
  • 在研究期间怀孕或打算怀孕。 有生育能力的妇女将在入学时提交尿液样本妊娠试验。
  • 英语不流利和/或无法完成问卷

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Antidepressant (AD)

Subjects will be randomly assigned to receive the antidepressant medication for 4 months prescribed by a psychiatrist or an advanced practice provider supervised by a psychiatrist. During Phase 1 phone calls every 2 weeks or in person visits will be used to evaluate the treatment and adjust the medication. If the patient was prescribed opioids prior to study entry, they will meet separately with a study physician to discuss possible weaning during the first 4 months (Phase 1)

Non-responders determined at the end of 4 months will be re-randomized to continue receiving AD or EFAR for another 4 months.
药品：抗抑郁药

抗抑郁治疗利用抗抑郁药物来改善疼痛、功能和抑郁结果。

抗抑郁药治疗史表 (ATHF) 将用于评估任何先前抗抑郁药治疗的充分性，并协助决定开始使用哪种抗抑郁药。 药物流程图将有助于在整个药物选择和剂量确定过程中充当指南。 受试者完成的每周评估将有助于确定反应、耐受性和调整剂量或改变药物的必要性。

其他名称：
  • AD：阿立哌唑、安非他酮、度洛西汀、艾司西酞普兰、米氮平、舍曲林、文拉法辛
实验性的：Enhanced Fear Avoidance Rehabilitation (EFAR)

Subjects will be randomly assigned to receive 8, 1-hour fear avoidance rehabilitation sessions conducted by a physical or occupational therapist, consisting of therapy sessions, pain education, and motivational messaging via a pain education self-help app for 4 months. Trained physical/occupational therapists will determine the activities as part of the treatment. If the patient was prescribed opioids prior to study entry, they will meet separately with a study physician to discuss possible weaning during the first 4 months (Phase 1).

Non-responders determined at the end of 4 months will be re-randomized to continue receiving EFAR or AD for another 4 months.
其他：Enhanced Fear Avoidance Rehabilitation
The EFAR treatment utilizes standardized physical and/or occupational therapy fear avoidance approaches, including pain education, and motivational messaging to improve pain, function, and depression outcomes. Subjects will engage in gradual exposure to exercises and activities they are apprehensive about, such as standing to wash dishes.
其他名称：
  • 埃法尔
实验性的：Antidepressant (AD) + Enhanced Fear Avoidance Rehabilitation (EFAR)
Subjects will receive a combination of antidepressant medication and EFAR for the first 4 months (Phase 1). In the 2nd 4 months (Phase 2) the AD treatment will be continued at the same dose(s) and they will be asked to maintain a home exercise program. If the patient was prescribed opioids prior to study entry, they will meet separately with a study physician to discuss possible weaning during the first 4 months (Phase 1). No re-randomization will be done in this treatment group.
药品：抗抑郁药

抗抑郁治疗利用抗抑郁药物来改善疼痛、功能和抑郁结果。

抗抑郁药治疗史表 (ATHF) 将用于评估任何先前抗抑郁药治疗的充分性，并协助决定开始使用哪种抗抑郁药。 药物流程图将有助于在整个药物选择和剂量确定过程中充当指南。 受试者完成的每周评估将有助于确定反应、耐受性和调整剂量或改变药物的必要性。

其他名称：
  • AD：阿立哌唑、安非他酮、度洛西汀、艾司西酞普兰、米氮平、舍曲林、文拉法辛
其他：Enhanced Fear Avoidance Rehabilitation
The EFAR treatment utilizes standardized physical and/or occupational therapy fear avoidance approaches, including pain education, and motivational messaging to improve pain, function, and depression outcomes. Subjects will engage in gradual exposure to exercises and activities they are apprehensive about, such as standing to wash dishes.
其他名称：
  • 埃法尔
实验性的：AD -> EFAR

Subjects will be randomly assigned to receive the antidepressant medication for 4 months prescribed by a psychiatrist or an advanced practice provider supervised by a psychiatrist. During Phase 1 phone calls every 2 weeks or in person visits will be used to evaluate the treatment and adjust the medication. If the patient was prescribed opioids prior to study entry, they will meet separately with a study physician to discuss possible weaning during the first 4 months (Phase 1)

Non-responders determined at the end of 4 months will be re-randomized to continue receiving AD or EFAR for another 4 months. Those re-randomized to EFAR for 4 months will receive 8 treatment visits. The same opioid weaning process will be followed as in Phase 1.
药品：抗抑郁药

抗抑郁治疗利用抗抑郁药物来改善疼痛、功能和抑郁结果。

抗抑郁药治疗史表 (ATHF) 将用于评估任何先前抗抑郁药治疗的充分性，并协助决定开始使用哪种抗抑郁药。 药物流程图将有助于在整个药物选择和剂量确定过程中充当指南。 受试者完成的每周评估将有助于确定反应、耐受性和调整剂量或改变药物的必要性。

其他名称：
  • AD：阿立哌唑、安非他酮、度洛西汀、艾司西酞普兰、米氮平、舍曲林、文拉法辛
其他：Enhanced Fear Avoidance Rehabilitation
The EFAR treatment utilizes standardized physical and/or occupational therapy fear avoidance approaches, including pain education, and motivational messaging to improve pain, function, and depression outcomes. Subjects will engage in gradual exposure to exercises and activities they are apprehensive about, such as standing to wash dishes.
其他名称：
  • 埃法尔
实验性的：EFAR -> AD

Subjects will be randomly assigned to receive 8, 1-hour fear avoidance rehabilitation sessions conducted by a physical or occupational therapist, consisting of therapy sessions, pain education, and motivational messaging via a pain education self-help app for 4 months. Therapists will determine the activities as part of the treatment. If the patient was prescribed opioids prior to study entry, they will meet separately with a study physician to discuss possible weaning during the first 4 months (Phase 1).

Non-responders at the end of 4 months will be re-randomized to continue receiving EFAR or AD for another 4 months (Phase 2). Those re-randomized to receive AD will be prescribed medications by a psychiatrist or an advanced practice provider supervised by a psychiatrist. Phone calls every 2 weeks or in person visits will be used to evaluate the treatment and adjust the medication.

The same opioid weaning process will be followed as in Phase 1.
药品：抗抑郁药

抗抑郁治疗利用抗抑郁药物来改善疼痛、功能和抑郁结果。

抗抑郁药治疗史表 (ATHF) 将用于评估任何先前抗抑郁药治疗的充分性，并协助决定开始使用哪种抗抑郁药。 药物流程图将有助于在整个药物选择和剂量确定过程中充当指南。 受试者完成的每周评估将有助于确定反应、耐受性和调整剂量或改变药物的必要性。

其他名称：
  • AD：阿立哌唑、安非他酮、度洛西汀、艾司西酞普兰、米氮平、舍曲林、文拉法辛
其他：Enhanced Fear Avoidance Rehabilitation
The EFAR treatment utilizes standardized physical and/or occupational therapy fear avoidance approaches, including pain education, and motivational messaging to improve pain, function, and depression outcomes. Subjects will engage in gradual exposure to exercises and activities they are apprehensive about, such as standing to wash dishes.
其他名称：
  • 埃法尔

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
"Composite Responder", Involving the Domains of Pain, Function, and Depression. See "Other Pre-Specified Outcomes" for Description of These Sub-components.
大体时间：Baseline vs. 4th month of study

To create the "composite responder" measure, Pain+ function changes will be 1 meaure, and the response rate to depression will be the 2nd component, which simplifies the assessment of multi-domain responses. We will determine the "composite responder" rate of multimodal vs. single-modal treatment primarily, and then between each arm secondarily, along with the subcomponents. The "composite responder" measure will be the number and percentage of participants meeting the measure in each arm in Phase 1.

A participant could be a pain+function responder, a depression responder, both, or neither. We use standard benchmarks for determining responses in each domain. The primary outcome is the rate of response vs. non-response on the "Composite Responder" measure. It will be expressed as percentiles in each category. We will also report the rate of pain+function responders and the rate of depression responders (other pre-specified outcomes).
Baseline vs. 4th month of study

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline Pain Interference at 4 Months Using PROMIS
大体时间：Baseline vs. 4 months
The PROMIS Short Form v1.1 - Pain Interference 4a will assess self-reported consequences of pain with 4 questions ranked on a 5-point scale, from "not at all" to "very much". The minimum raw summed score is 4 and the maximum score is 20. This is converted to a T score. A lower T-scores suggest better outcomes. The population mean is 50 and 10 points is +/- 1 standard deviation. A T score >60 suggests moderately elevated levels of the measure. Outcomes will be measured and compared between the 3 treatment groups.
Baseline vs. 4 months
Change From Baseline Anxiety at 4 Months Using PROMIS
大体时间：Baseline vs. 4 months
The PROMIS Short Form v1.0 - Anxiety 4a will assess self-reported symptoms with 4 questions ranked on a 5-point scale, from "never" to "always". The minimum raw score is a 4 and the maximum is 20.. These are converted to a T score. The population mean is 50 and 10 points is +/- 1 standard deviation. A T score >60 suggests moderately elevated levels of the measure. Lower T-scores suggest better outcomes. Outcomes will be measured and compared between the 3 treatment groups.
Baseline vs. 4 months
Change From Baseline Sleep Disturbance at 4 Months Using PROMIS
大体时间：Baseline vs. 4 months
The PROMIS Short Form v1.0 - Sleep Disturbance 6a self-reported perceptions of sleep quality and sleep depth with 6 questions ranked on a 5-point scale. The minimum raw summed score is 6 and the maximum score is 30. This is converted to a T score. Lower T scores suggest better outcomes. Outcomes will be measured and compared between the 3 treatment groups. The population mean is 50 and 10 points is +/- 1 standard deviation. A T score >60 suggests moderately elevated levels of the measure.
Baseline vs. 4 months
Change From Baseline Subject's Perception of Change From Treatment at 4 Months Using Patient Global Impression of Change (PGIC)
大体时间：Baseline vs. 4 months
The subject's impression of the impact of the treatment on their pain and function will be measured with a 7-item scale (1 = very much worse, 2 = much worse, 3 = minimally worse, 4 = no change, 5 = minimally improved, 6 = much improved, 7 = very much improved). This is the percentage reporting "very much improved" or "much improved" at the end of Phase 1. We averaged their PGIC ratings in the 4th month.
Baseline vs. 4 months
Neuropathic Pain Symptoms Change, Baseline vs. 4 Months
大体时间：Baseline vs. 4 months
Using PainDetect, we will compare changes in neuropathic pain symptoms from baseline to 4 months. PainDetect is scored from 0-38 and based on ratings to symptom items scored from '0' (never) to '5' (very strongly). Lower scores are better.
Baseline vs. 4 months
Fear Avoidance Beliefs, Baseline vs. 4 Months
大体时间：Baseline vs. 4 months
Using the Fear Avoidance Beliefs Questionnaire, Physical Activities Items, subjects rate from '0' (completely disagree) to '6' (completely agree) five physical activities which may make their pain worse. The items are summed to produce the total score. The minimum score is a 0 and the maximum is a 30. Lower scores are better.
Baseline vs. 4 months
Widespread Pain Index
大体时间：Baseline vs. 4 months
This measure assesses the degree of widespread pain. 20 body regions are rated by patient as having pain or not. The minumum scores is a 0 and the maximum is a 20. The number of regions is summed to give the total score. Lower scores are better.
Baseline vs. 4 months
Change in PROMIS Fatigue Score From Baseline vs. 4 Months
大体时间：Baseline vs. 4 months
The PROMIS short form v. 1.0 for Fatigue consists of 2 items rated from 1-5, from "not at all" to "very much." The minimum raw score is a 2 and the maximum is a 10. The raw score is summed and converted to a T score. Lower T scores are better. The population mean is 50 and 10 points is +/- 1 standard deviation. A T score >60 suggests moderately elevated levels of the measure.
Baseline vs. 4 months
WPI Symptom Severity Score
大体时间：Baseline to 4 months
Overall symptom severity is rated 0-10. Lower scores are better.
Baseline to 4 months

其他结果措施

结果测量
措施说明
大体时间
Change in Physical Function Using PROMIS Short Form 2.0. Function is Part of the Composite Responder Measure, and a Pain+Function Metric More Specifically. A Subject Could be a Pain+Function Responder, a Depression Responder, Both, or Neither.
大体时间：Baseline vs. 4 months
The PROMIS Short Form v2.0 - Physical Function 6b questionnaire will assess self-reported capability with 6 qualitatively scaled questions ranked on a 5-point scale, from "without any difficulty" to "unable to do" or "not at all" to "cannot do." The minimum raw summed score is 6 and the maximum score is 30. Lower t-scores suggest better outcomes. A responder analysis was used as a subcomponent of the "composite responder" primary outcome. A "physical function responder" had to have at least a 3-point improvement in T score at 4 months vs. baseline. The "physical function responder" measure will be the number and percentage of participants meeting the measure in each arm in Phase 1.
Baseline vs. 4 months
Change in Pain Intensity Using PROMIS. Pain is Part of the Composite Responder Measure, and a Pain+Function Metric More Specifically. A Subject Could be a Pain+Function Responder, a Depression Responder, Both, or Neither.
大体时间：Baseline vs. 4 months
The PROMIS Numeric Rating Scale v1.0 for average pain intensity-- Pain Intensity 1a questionnaire will assess how much a person hurts on average over the past 7 days, with a question ranked on a 11-point scale, from "0 = no pain" to "10 = worst imaginable pain." The minimum raw summed score is 0 and the maximum score is 10. Lower scores suggest lower pain intensity and better outcomes. To be a "pain responder" a subject had to have at least 30% improvement in pain. The "pain responder" measure will be the number and percentage of participants meeting the measure in each arm in Phase 1.
Baseline vs. 4 months
Change in Depression Using PROMIS. Depression is Part of the "Composite Responder" Measure. A Subject Could be a Pain+Function Responder, a Depression Responder, Both, or Neither.
大体时间：Baseline vs. 4 months
The PROMIS Short Form v1.0 - Depression 4a will assess self-reported negative mood and views of self with 4 questions ranked on a 5-point scale, from "never" to "always". The minimum raw summed score is 4 and the maximum score is 20. Lower T scores suggest better outcomes. A T score improvement of at least 5 points is considered a responder. The "depression responder" measure will be the number and percentage of participants meeting the measure in each arm in Phase 1.
Baseline vs. 4 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ajay Wasan, MD, Msc

合作者

Massachusetts General Hospital
Mayo Clinic
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health (NIH)

调查人员

  • 首席研究员：Ajay Wasan, MD, MSc、University of Pittsburgh

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年3月31日

初级完成 (实际的)

2024年11月4日

研究完成 (实际的)

2024年12月20日

研究注册日期

首次提交

2021年1月6日

首先提交符合 QC 标准的

2021年2月5日

首次发布 (实际的)

2021年2月10日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月27日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STUDY21010105
  • UG3AR076568 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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