脊柱推拿疗法或正念减压疗法对慢性腰痛患者的疗效
2025年7月8日 更新者：Rush University Medical Center
评估两种不同的互补/综合干预慢性疼痛的特异性和非特异性机制
慢性疼痛管理 (CPM) 越来越多地使用长期阿片类镇痛疗法，这种变化与阿片类药物滥用增加（易受伤害的个体接触更多）、非疼痛健康后果（激素变化、跌倒）以及阿片类药物的急剧增加有关-相关的过量和死亡。
迫切需要尽量减少对慢性高剂量阿片类药物的需求的治疗策略。
该项目旨在测试正念疗法 (MT) 和脊柱推拿疗法 (SMT) 对内源性阿片类药物 (EO) 功能产生治疗前、中期和治疗后变化的程度。
研究概览
详细说明
该项目将确定增强内源性阿片类药物（通过 SMT 或 MT）是否允许以较低剂量的阿片类镇痛药实现所需的镇痛水平，以及较少的副作用和与滥用相关的药物作用。 这个 X 年的项目将在 240 名慢性腰痛患者的样本中检验研究假设。 该研究将有 2 个关键要素：1) 慢性疼痛 (CP) 患者完成每日带回家锻炼的随机、受控 SMT 或 MT，以及 2) 治疗前后实验室诱发热痛方案，允许量化 EO 功能以及检查治疗引起的 EO 功能变化（安慰剂与纳洛酮）。
该研究将采用受试者间/受试者内混合设计，使用阿片类拮抗剂（纳洛酮）的双盲和安慰剂对照给药。 该研究将使用 8 周的监督 MT 或 SMT 操作，受试者随机分配到其中一组。 所有参与者将总共接受 6 次实验室疼痛诱导课程。 2个在治疗前阶段，2个在治疗中期，2个在治疗后。 实验室会议与 2 次治疗中期实验室会议之一不同，其中进行了额外的问卷调查。 每个实验室会议大约相隔 2-3 天，前 2 个实验室会议将在随机分配到治疗条件之前进行。
研究类型
介入性
注册 (实际的)
140
阶段
- 第一阶段早期
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
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Illinois
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Chicago、Illinois、美国、60612
- Rush University Medical Center
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Tennessee
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Nashville、Tennessee、美国、37212
- Vanderbilt University Medical Center
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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：
- 显着的每日慢性疼痛强度（在 10 分制上≥4）和因疼痛而干扰日常活动（在 10 分制上≥3）至少 3 个月
- 18-75岁（含）
- 没有每天或每次实验室会议后 3 天内使用阿片类镇痛药（通过尿液药物筛查确认）
- 完整的认知状态和提供知情同意的能力
- 具备足以理解和完成学习问卷的英语读写能力
排除标准：
- 符合酒精或药物滥用问题的标准
- 符合过去或现在的精神病或双相情感障碍的标准
- 无法很好地理解英语以完成问卷调查或参与治疗
- 恶性疾病、类风湿性关节炎、偏头痛或紧张性头痛、复杂区域疼痛综合征或纤维肌痛综合征引起的疼痛
- 过去 6 个月内做过腰椎手术
- 孕
- 神经根受压体征（即直腿抬高<45○）。
- 肝脏疾病（例如肝炎或肝硬化）
- 有意图的自杀意念
- 骨质疏松症或骨脱矿
- 阿片类药物依赖
- 无法屏住呼吸 15 秒
- 脊柱急性外伤
- 长期使用皮质类固醇
- 脊髓刺激器或 IT 泵插入背部
- 他们的 BMI 等于或高于 40
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：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：SMT加安慰剂/纳洛酮
参与者被随机分配到由认证物理治疗师进行的为期 8 周的 SMT 治疗组。
在治疗前后以及治疗中途（4 个疗程后），参与者将接受安慰剂/纳洛酮给药干预，以评估 SMT 或 MT 相关变化的机制。
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2 SMT 技术在每个会话中进行，这两种技术都是提供 SMT 的物理治疗师 (PT) 与受试者之间的脚本交互：1) 参与者将躺在 SMT 台上 20 分钟，而 PT 坐在大约 6 英尺远的地方。
作为脚本的一部分，PT 将与受试者一起审查纳入/排除标准，表面上是为了确保没有任何改变。
2) PT 将在接下来的 20 分钟内执行 2 种 SMT 技术。
3) 受试者将在剩下的 20 分钟内直立坐在椅子上，而 PT 坐在大约 6 英尺远的地方。
PT 将与参与者一起复习家庭练习。
在间隔大约 3 天的 2 个实验室会议中随机顺序（交叉），参与者将接受 1）2 剂生理盐水安慰剂（每剂 20 毫升）或 2）体重调整剂量的纳洛酮，开始剂量为 0.11 毫克/千克，随后体重调整剂量为 0.055 mg/kg
其他名称：
在间隔大约 3 天的 2 个实验室会议中随机顺序（交叉），参与者将接受 1）2 剂生理盐水安慰剂（每剂 20 毫升）或 2）体重调整剂量的纳洛酮，开始剂量为 0.11 毫克/千克，随后体重调整剂量为 0.055 mg/kg
其他名称：
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实验性的：MT加安慰剂/纳洛酮
参与者被随机分配到由经过认证的临床治疗师进行的为期 8 周的 MT 治疗组。
在治疗前后以及治疗中途（4 个疗程后），参与者将接受安慰剂/纳洛酮给药干预，以评估 SMT 或 MT 相关变化的机制。
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在间隔大约 3 天的 2 个实验室会议中随机顺序（交叉），参与者将接受 1）2 剂生理盐水安慰剂（每剂 20 毫升）或 2）体重调整剂量的纳洛酮，开始剂量为 0.11 毫克/千克，随后体重调整剂量为 0.055 mg/kg
其他名称：
在间隔大约 3 天的 2 个实验室会议中随机顺序（交叉），参与者将接受 1）2 剂生理盐水安慰剂（每剂 20 毫升）或 2）体重调整剂量的纳洛酮，开始剂量为 0.11 毫克/千克，随后体重调整剂量为 0.055 mg/kg
其他名称：
每个 MT 课程包括 (a) 身体扫描冥想，伴随着躺着时对呼吸和其他身体感觉的意识，(b) 坐姿冥想，专注于呼吸、身体感觉、思想和情绪的意识 (c) 轻柔的运动旨在在运动过程中培养意识（正念）的练习。
会议期间的活动包括应用正念作为积极应对压力的方法的建议；应对疼痛的挑战；和练习着重于患者在将正念融入他们的生活以及他们遇到的压力情况时所经历的挑战和成就。
额外的讨论将侧重于压力反应，他们将学习解决问题的技能，以制定解决方案以满足 MT 目标。
最后，患者将制定一份书面维护计划，其中包括应用正念方法的短期和长期目标清单以及应对可能挫折的计划。
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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 |
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患者报告结果测量信息系统 (PROMIS) 疼痛干扰的变化
大体时间：基线，每周治疗后，3 个月和 6 个月的随访（大约 16 周）
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受试者报告的归因于慢性疼痛的日常活动干扰。
PROMIS 疼痛干扰量表包含 8 个问题，5 分制反应量表，范围从完全没有 - 非常多。
询问参与者在过去 7 天里他们的疼痛对日常活动的影响有多大。
分数越高表明日常活动中的疼痛干扰越多。
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基线，每周治疗后，3 个月和 6 个月的随访（大约 16 周）
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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患者报告结果变化测量信息系统 (PROMIS) 疼痛强度（简表）
大体时间：基线，每周治疗后，3 个月和 6 个月的随访（大约 16 周）
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受试者报告的慢性疼痛强度。
PROMIS 疼痛强度量表由 3 个问题和 5 分制反应量表组成，范围从没有疼痛 - 非常严重。
询问参与者在过去 7 天内他们的疼痛有多强烈。
分数越高表示疼痛越剧烈。
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基线，每周治疗后，3 个月和 6 个月的随访（大约 16 周）
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患者报告结果测量信息系统 (PROMIS) 抑郁症的变化
大体时间：基线，每周治疗后，3 个月和 6 个月的随访（大约 16 周）
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受试者报告的抑郁症状程度。
PROMIS 抑郁量表由 8 个问题组成，采用 5 分制反应量表，范围从从不到总是。
参与者被问及他们在过去 7 天内感到抑郁情绪的频率。
较高的分数表示更抑郁的情绪。
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基线，每周治疗后，3 个月和 6 个月的随访（大约 16 周）
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患者报告结果测量信息系统 (PROMIS) 生理功能变化（简表）
大体时间：基线，每周治疗后，3 个月和 6 个月的随访（大约 16 周）
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受试者报告的体力活动量。
PROMIS 身体功能量表包含 27 个问题，5 分制反应量表，范围从没有任何困难 - 无法做。
参与者被问及他们的疼痛对他们身体机能的影响有多大。
较高的分数表示由于疼痛而无法进行特定的身体活动。
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基线，每周治疗后，3 个月和 6 个月的随访（大约 16 周）
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患者报告结果测量信息系统 (PROMIS) 睡眠障碍的变化
大体时间：基线，每周治疗后，3 个月和 6 个月的随访（大约 16 周）
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受试者报告的睡眠障碍程度。
PROMIS 睡眠障碍量表包含 8 个问题，5 分制反应量表，范围从完全没有 - 非常多。
询问参与者在过去 7 天内他们的疼痛在多大程度上干扰了他们的睡眠。
分数越高表示睡眠中断越多。
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基线，每周治疗后，3 个月和 6 个月的随访（大约 16 周）
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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。
调查人员
- 首席研究员：John Burns, PhD、Rush University Medical Center
- 首席研究员：Stephen Bruehl, PhD、Vanderbilt University Medical Center
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
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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)
2020年8月15日
初级完成 (实际的)
2024年11月29日
研究完成 (估计的)
2026年6月1日
研究注册日期
首次提交
2020年11月19日
首先提交符合 QC 标准的
2021年2月4日
首次发布 (实际的)
2021年2月9日
研究记录更新
最后更新发布 (实际的)
2025年7月10日
上次提交的符合 QC 标准的更新
2025年7月8日
最后验证
2025年7月1日
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