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脊柱手术后的远程医疗正念

2026年7月22日 更新者:Carrie Brintz、Vanderbilt University Medical Center

腰椎手术后远程医疗正念干预:随机对照试验

该试点临床试验的目的是比较两种行为干预措施,这些干预措施适用于因退行性脊柱疾病而从腰椎手术中恢复过来的患者。 该研究旨在回答以下问题:

  1. 在该患者群体中实施干预和开展研究程序是否可行且可接受?
  2. 这些干预措施在术后 3 个月和 6 个月的疼痛相关、功能、阿片类药物使用和社会心理结果方面是否有益于患者,一种干预措施是否比另一种干预措施更有益?

参与者将被要求做以下事情:

  1. 在脊柱手术前以及脊柱手术后约 2 周、3 个月和 6 个月在线完成自我报告问卷。
  2. 在脊柱手术前以及脊柱手术后约 2 周、3 个月和 6 个月完成一项感觉疼痛任务。
  3. 手术后大约两周,参与者将随机分配到两种行为干预中的一种——正念或教育。 然后,参与者将被要求参加 8 次每周一次的远程医疗(使用摄像头和麦克风在线)与研究治疗教练的会议。

研究概览

详细说明

这是一项随机临床试验,比较远程医疗正念干预 (MBI) 和远程医疗教育干预 (EDU) 对脊柱手术康复患者的影响。 程序如下:

  1. 在范德比尔特综合脊柱中心接受腰椎退行性脊柱手术前的患者入组。 招募、登记和筛选将在例行的术前门诊就诊时或通过电话进行。
  2. 在登记的参与者完成手术两周后,他们将以 3:2 的比例随机分配到 MBI 或 EDU 条件。 随机化将根据术前长期使用阿片类药物(是/否)进行分层。 在随机化之前,随机分配将对所有研究人员保密。 结果评估员和手术提供者将对参与者的研究条件保持不知情。
  3. 在手术后的四个星期内,参与者将开始指定的干预。 干预措施将包括与一名干预人员会面,每周通过在线远程医疗平台进行八次一对一的远程医疗 MBI 会议。 MBI 课程将由临床心理学家主持,时长 75 分钟(第一节课 90 分钟)。 EDU 课程将由物理治疗师主持,时长 30 分钟。 会议将被录音并监控保真度。

3) 参与者将在手术前、手术后两周(干预前)、手术后三个月(干预后)和手术后 6 个月在线完成自我报告评估。

4) 参与者将在手术前、手术后两周、手术后三个月和手术后 6 个月完成疼痛耐受性、疼痛阈值和疼痛时间总和的定量感官测试评估。

研究类型

介入性

注册 (实际的)

67

阶段

  • 不适用

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

    • Tennessee
      • Nashville、Tennessee、美国、37232
        • Vanderbilt University Medical Center

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 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准:

  1. 说英语的成年人
  2. 年满 18 岁
  3. 计划在范德比尔特脊柱中心进行椎板切除术和/或融合术
  4. 计划进行他们的第一次腰椎手术
  5. 退行性疾病的放射学证据,包括但不限于椎管狭窄、伴有或不伴有脊髓病的脊椎病和脊椎滑脱
  6. 背部和/或下肢疼痛持续至少 3 个月
  7. 访问稳定的互联网。
  8. 能够在手术后 8 周内每周与研究治疗师一起参加远程会议

排除标准:

  1. 显微外科技术作为主要程序(即 单独的椎板切开术或显微椎间盘切除术)
  2. 针对脊柱畸形的主要指征进行手术
  3. 继发于假关节形成、外伤、感染或肿瘤的手术
  4. 原发性精神病或主要思想障碍的当前/历史或因与精神病相关的原因住院(例如 精神分裂症、短暂性精神病、妄想症)。 药物诱发的精神病不是排他性的。
  5. 阿尔茨海默病或其他形式的痴呆症的诊断
  6. 创伤性脑损伤(严重程度大于轻度)
  7. 双相情感障碍或解离障碍史
  8. 活性物质使用障碍(上个月)
  9. 目前的创伤后应激障碍 (PTSD) 症状(过去一个月)
  10. 有意图的主动自杀意念

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
实验性的:远程医疗正念干预 (MBI)
八次每周一次的远程健康正念课程,与正念教练进行一对一的授课
远程医疗 MBI 改编自针对慢性疼痛的基于正念的认知疗法,包括八次每周 75 分钟的个人会议(第一次会议分配 90 分钟),正念干预师提供远程医疗干预(在线音频和摄像机) ) 除了患者接受他们通常的术后护理。 参与者将在完成 2 周的术后评估后和手术后 4 周内开始干预。 参与者将被要求在会议之间每天练习大约 20-40 分钟的技能。
有源比较器:远程医疗教育 (EDU)
每周八次与物理治疗师进行一对一的术后教育课程
参与者将在随机化时(手术后 2-4 周内)和 8 次每周 30 分钟的远程医疗会议以及常规的术后护理收到一份书面教育手册。 物理治疗师在每周一次的远程医疗会议(通过音频和摄像机在线)期间与参与者单独审查教育材料。

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
干预满意度
大体时间:术后3个月
总体满意度大于或等于 7 分(满分 10 分)的参与者比例
术后3个月
Enrollment Rate
大体时间:Preoperatively, from when the potential participant is approached for recruitment until the time at which a potential participant is either eligible and consents to enroll in the study, or is ineligible or declines to enroll in the study, up to 2 weeks.
Proportion of participants approached who are eligible and enroll in the study
Preoperatively, from when the potential participant is approached for recruitment until the time at which a potential participant is either eligible and consents to enroll in the study, or is ineligible or declines to enroll in the study, up to 2 weeks.
Participant Study Retention
大体时间:6 months postoperative
Proportion of participants who complete the study (6 month assessment)
6 months postoperative
Session Attendance
大体时间:Through 3 months postoperative
Average proportion of sessions attended out of 8 sessions
Through 3 months postoperative
Home Practice Completion
大体时间:Through 3 months postoperative
Average days practiced out of days assigned practice (MBI group only)
Through 3 months postoperative

次要结果测量

结果测量
措施说明
大体时间
疼痛困扰
大体时间:术前、术后2周、术后3个月、术后6个月
一项评估过去 7 天疼痛程度的项目,从 0 = 完全没有到 4 = 极度疼痛。 较低的分数表示较低的疼痛烦扰度。
术前、术后2周、术后3个月、术后6个月
Pain Interference Short-form 8a
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Interference short-form 8a from the Patient Reported Outcomes Measurement Information System scale. Measures interference of pain over the past 7 days. Consists of 8 items with response options from 1 = not at all to 5 = very much. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. A lower score indicates lower pain interference, or a better outcome.
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Back Pain Intensity
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
1 item assessing back pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off. Lower scores indicate less pain, or better outcome.
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Leg Pain Intensity
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
1 item assessing leg pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off. Lower scores indicate less pain, or better outcome.
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Anxiety Short Form 4a
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. 4 items assessing anxiety symptoms in the past 7 days (e.g. "I felt fearful") with response options from 1 = never to 5 = always. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. Lower scores represent lower anxiety, a better outcome
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Physical Function
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Physical Function short-form 4a - Patient Reported Outcomes Measurement Information System. 4 items assessing physical function in the past 7 days (e.g. "Are you able to do chores such as vacuuming or yard work?") with response options from 1 = Unable to do to 5 = Without any difficulty. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. Higher scores represent better physical function, a better outcome
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Depression Short Form 4a
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. 4 items assessing depressive symptoms over the past 7 days (e.g. "I felt worthless) with response options from 1 = never to 5 = always. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. A lower score indicates less depression, a better outcome.
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Sleep Disturbance Short Form 4a
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Sleep disturbance short-form 4a - Patient Reported Outcomes Measurement Information System scale. 4 items assessing sleep disturbance over the past 7 days (e.g. "I had difficulty falling asleep) with response options from 1 = not at all to 5 = very much (1 item reverse-scored). The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. A lower score indicates less sleep disturbance, a better outcome.
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Oswestry Disability Index
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Assesses impact of pain on level of functioning in 10 areas (e.g. walking, sleep, social life) with 10 items with response options with scores 0 to 5. Total scores are calculated as a percentage, ranging from 0% to 100%. Lower scores indicate a lower level of disability due to pain, a better outcome.
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Catastrophizing Scale
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
13 items assessing thoughts and feelings when in pain (e.g. "I become afraid that the pain will get worse" with response options ranging from 0 = never to 4 = all the time. Total scores range from 0 to 52 units on the scale. Lower scores indicate lower pain catastrophizing, a better outcome.
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Self-efficacy Questionnaire
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
10 items assessing confidence in ability to do certain things despite pain (e.g. "I can enjoy things, despite the pain" with response options 0 = not at all to 6 = completely. Total scores range from 0 to 60 units on the scale. Higher scores indicate greater pain self-efficacy, a better outcome.
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Perceived Stress Scale - 4
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
4 items assessing perceived level of stress in the past month (e.g. "In the last month, how often have you felt that you were unable to control the important things in your life?"), with response options ranging from 0 = never to 4 = very often (2 items reverse-scored). Total scores range from 0 to 16 units on the scale. Lower scores indicate lower perceived stress, a better outcome.
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Tampa Scale for Kinesiophobia -13
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
13 items assessing fear of movement (e.g. "I'm afraid that I might injure myself if I exercise" with response options ranging from 1 = strongly disagree to 4 = strongly agree. Total scores range from 13 to 52 units on the scale. Lower scores indicate lower levels of kinesiophobia, a better outcome.
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Five Facet Mindfulness Questionnaire - 15
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
15 items assessing 5 facets of mindfulness, including observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Response options range from 1 = never to 5 = always (7 items reverse scored). Total scores are an average of the sum of all items, ranging from 1 to 5 units on the scale. Higher scores indicate higher levels of mindfulness, a better outcome.
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Number of Participants Indicating They Currently Use Opioids
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Participants were asked in one item "Are you currently taking an opioid medication?" Response options included "Yes" or "No." A response of Yes counted as 1 and No counted as 0 when calculating total frequency of participants reporting current opioid use.
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Tolerance
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
The duration of time participants tolerated an inflated blood pressure cuff: Using an ischemic task involving squeezing a dynamometer followed by inflated blood pressure cuff on arm, the time in seconds at which the participant indicated they could no longer tolerate the stimulus (inflated blood pressure cuff). Scores could range from 0 seconds to 300 seconds, as the task was discontinued at 300 seconds if reached prior to the participant indicating to stop the task.
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Threshold
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Duration at which participants indicate a stimulus is experienced as painful: Using an ischemic task involving squeezing a dynamometer followed by inflated blood pressure cuff on arm, the point in seconds at which the stimulus (inflated blood pressure cuff) is first reported by the participant as painful. Scores could range from 0 seconds to 300 seconds, as the task was discontinued at 300 seconds if participants did not yet indicate that the stimulus was painful.
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Temporal Summation of Pain
大体时间:Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Using a punctate stimuli (von frey hairs of 100g and 180g of force to the finger), the difference between reported pain intensity during a single prick and the reported highest pain intensity during repeated brief pricks at a constant intensity. Pain intensity was measured on a scale of 0 to 100. The difference score was calculated by subtracting the pain intensity with single prick from the pain intensity with repeated pricks and could range from 0 to 100 units of difference on the pain intensity scale. Lower values are a more favorable outcome.
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative

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:Carrie E Brintz, PhD、Vanderbilt University Medical Center

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)

2023年2月22日

初级完成 (实际的)

2025年7月11日

研究完成 (实际的)

2025年7月11日

研究注册日期

首次提交

2022年12月27日

首先提交符合 QC 标准的

2023年1月16日

首次发布 (实际的)

2023年1月26日

研究记录更新

最后更新发布 (实际的)

2026年8月13日

上次提交的符合 QC 标准的更新

2026年7月22日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 221711
  • K23AT011569 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

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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