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PNE Effectiveness Cluster Trial (PNE)

2020年7月28日 更新者：Elizabeth Lane、University of Utah

The Effectiveness of Training Physical Therapists in Pain Neuroscience Education on Patient Reported Outcomes for Patients With Chronic Spinal Pain

This is a cluster randomized trial that involves training regions of physical therapy clinics to use pain neuroscience education or continue with usual care. The investigators will examine outcomes for patients with chronic neck or back pain.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Chronic spinal pain is a very common and costly condition. An estimated 26.4% of Americans have experienced an episode low back pain (LBP) and 13.8% have experienced neck pain in the past 3 months. Lifetime prevalence of spinal pain ranges from 54% to 80% and the estimated healthcare costs for those with spinal pain are 57% higher than those without. While many with acute LBP have a favorable prognosis, those who develop chronic pain continue will experience persistent poor health and place a large burden on the healthcare system.

With growing healthcare costs and mounting disability, there is increased demand for physical therapists to promote more effective self-management strategies for patients with chronic spinal pain. Education is a critical component of self-management. Pain neuroscience education (PNE) is an education method used by physical therapists to help patients understand the biology, physiology and psychological factors influencing their pain experience and to reconcile faulty cognitions and beliefs associated with persistent pain and disability8. PNE has been shown to have positive effects on patient-reported outcomes for a variety of spinal pain conditions. This study will examine the impact of widespread implementation of PNE into routine physical therapy care.

The proposed mechanism of PNE is proposed to relate changes in patients' conceptualization of the pain experience, specifically concepts associated with fear, knowledge, and beliefs of pain. Additional research has identified autonomous motivation and self-efficacy as relevant to patients' behavioral responses to pain. Autonomous motivation is proposed to be an essential factor for behavior change, adhering to a treatment program and persistent positive health behavior changes. Autonomous motivation has not been examined as an influencing factor in the PNE model. Self-efficacy relates to the degree an individual feels they have control over their situation; and high self-efficacy has been associated with more active coping efforts. This study will examine self-efficacy and autonomous motivation as potential mediators of the ability of a PNE intervention improve functional outcomes in a pragmatic clinical environment.

This project's overall goal is to determine the effectiveness of providing physical therapists with PNE training on patient-centered outcomes (physical function and pain interference) for patients with chronic neck or back pain receiving physical therapy. Secondarily, the investigators will explore mechanisms of effects of PNE by examining the role of autonomous motivation and self-efficacy. To accomplish these goals, the investigators will conduct a cluster-randomized clinical trial, randomly assigning groups of clinics to receive PNE training or usual care with no additional training for physical therapists working in the clinic. This design allows for maximum external validity and generalizability across outpatient physical therapy clinics.

Primary Aims I. Compare effectiveness of PNE training vs. no additional training for physical therapists on patient-centered outcomes (physical function and pain interference) for patients with chronic spinal pain. The investigators hypothesize patients receiving treatment from physical therapists receiving PNE education will show greater improvement in patient-centered outcomes.

Secondary Aims I. Compare the effects of PNE training vs. no additional training for physical therapists on the patient-physical therapist alliance. The investigators hypothesize patients receiving treatment from physical therapists receiving PNE education will show greater alliance with their physical therapist.

II. Explore the mediating effects of autonomous motivation and self-efficacy on patient-centered outcomes. The investigators hypothesize autonomous motivation and/or self-efficacy will mediate the effects of education on patient-centered outcomes.

研究类型

介入性

注册 (实际的)

316

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

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35242-8601
        • BenchMark
      • Birmingham、Alabama、美国、35243-2366
        • BenchMark
      • Helena、Alabama、美国、35080-3773
        • BenchMark
      • Hoover、Alabama、美国、35244-1254
        • BenchMark
      • Moody、Alabama、美国、35004-3101
        • BenchMark
      • Phenix City、Alabama、美国、36867-7484
        • BenchMark
    • Georgia
      • Acworth、Georgia、美国、30101-8352
        • Benchmark Physical Therapy
      • Alpharetta、Georgia、美国、30005-4202
        • BenchMark
      • Atlanta、Georgia、美国、30306-4530
        • BenchMark
      • Atlanta、Georgia、美国、30308-1245
        • BenchMark
      • Atlanta、Georgia、美国、30316-6833
        • BenchMark
      • Atlanta、Georgia、美国、30318-3117
        • BenchMark
      • Atlanta、Georgia、美国、30319
        • BenchMark
      • Atlanta、Georgia、美国、30342-1461
        • BenchMark
      • Austell、Georgia、美国、30106-8531
        • BenchMark
      • Canton、Georgia、美国、30114-5603
        • BenchMark
      • Canton、Georgia、美国、30115-9376
        • BenchMark
      • Carrollton、Georgia、美国、30117-4456
        • BenchMark
      • Cartersville、Georgia、美国、30121-3305
        • BenchMark
      • Columbus、Georgia、美国、31909-5649
        • BenchMark
      • Dallas、Georgia、美国、30157-4702
        • BenchMark
      • Decatur、Georgia、美国、30033-5305
        • BenchMark
      • Dunwoody、Georgia、美国、30338-4163
        • BenchMark
      • Hiram、Georgia、美国、30141-2692
        • BenchMark
      • Jasper、Georgia、美国、30143-8704
        • BenchMark
      • Kennesaw、Georgia、美国、30144-3210
        • BenchMark
      • Lawrenceville、Georgia、美国、30046-8767
        • Rehab South
      • Marietta、Georgia、美国、30060-9412
        • BenchMark
      • Marietta、Georgia、美国、30062-4197
        • BenchMark
      • Marietta、Georgia、美国、30064-5037
        • BenchMark
      • Marietta、Georgia、美国、30067-8642
        • BenchMark
      • Marietta、Georgia、美国、30068-5418
        • BenchMark
      • Newnan、Georgia、美国、30265-6506
        • Rehab South
      • Peachtree City、Georgia、美国、30269-1571
        • Rehab South
      • Peachtree City、Georgia、美国、30269
        • BenchMark
      • Roswell、Georgia、美国、30075-7524
        • BenchMark
      • Roswell、Georgia、美国、30076-0929
        • BenchMark
      • Roswell、Georgia、美国、30076-3866
        • BenchMark
      • Smyrna、Georgia、美国、30080-9213
        • BenchMark
      • Suwanee、Georgia、美国、30024-9104
        • BenchMark
      • Tucker、Georgia、美国、30084-4916
        • BenchMark

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 18-75 at time of first physical therapy session
  • Primary reason for physical therapy is low back and/or neck pain
  • Meets the NIH definition of chronic pain (i.e., neck or back pain on at least half the days in the past 6 months.)

Exclusion Criteria:

  • No spinal surgery within the previous 12 months
  • No evidence of "red flag" conditions (e.g., cauda equine syndrome, cancer, fracture, infection or systemic disease) that requires immediate referral from physical therapy to medical care
  • Not currently known to be pregnant

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：Usual Care
Usual care, no intervention
实验性的：Pain Neuroscience Education Training
The region of clinics randomized to this arm will receive PNE education, which consists of 6 weeks online training followed by an on-site training day.
其他：Pain neuroscience education training
PNE training will consist of 6 weeks online training followed by one day training session.

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
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
大体时间：2 week and 12 week
Change score of Physical Function scores from baseline
2 week and 12 week

次要结果测量

结果测量
措施说明
大体时间
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
大体时间：2 week and 12 week
Change score of Pain Interference scores from baseline
2 week and 12 week
pain self-efficacy
大体时间：2 week and 12 week
Measured by Pain Self-Efficacy Questionnaire
2 week and 12 week
Autonomous motivation
大体时间：2 week and 12 week
Measured by Treatment Self-regulation Questionnaire
2 week and 12 week
Therapeutic Alliance
大体时间：2 week and 12 week
As measured by Working Alliance Theory of Change Inventory
2 week and 12 week

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

University of Utah

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)

2017年5月24日

初级完成 (实际的)

2019年6月1日

研究完成 (实际的)

2019年6月1日

研究注册日期

首次提交

2017年5月23日

首先提交符合 QC 标准的

2017年5月24日

首次发布 (实际的)

2017年5月30日

研究记录更新

最后更新发布 (实际的)

2020年7月29日

上次提交的符合 QC 标准的更新

2020年7月28日

最后验证

2020年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 00097154

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

不

研究美国 FDA 监管的设备产品

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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