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临床试验/NCT05057988
NCT05057988已完成不适用

Virtual Empowered Relief for People With Chronic Pain Who Take Methadone or Buprenorphine

Stanford University2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2021年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
2
主要终点
Perceived Usefulness

研究概览

简要总结

The purpose of the current pilot study is to examine a feasibility and the preliminary efficacy of Empowered Relief (ER) class when it is delivered 'virtually' to patients with chronic pain who take methadone or buprenorphine. The ER class is a single-session pain management class, which has demonstrated to be effective in improving pain and pain-related distress in patients with chronic low back pain, but its efficacy has not been examined in patients with chronic pain who take methadone or buprenorphine. Class participants will learn self-regulatory skills and develop a personalized plan to use the skills every day. The current study will examine a feasibility and participant's perception and satisfaction of this class at post-class. The study will also follow participants 3 months by administering 5 surveys (baseline, 2 weeks and 1 month, 2 months, and 3 months post-treatment) to determine whether the class confers the short-term and medium-term benefits across various aspects of health.

详细描述

Some patients with chronic pain are on long-term opioid therapy. Methadone and buprenorphine are often used in long-term opioid therapy for chronic pain. Additionally, chronic pain is highly prevalent in people receiving methadone or buprenorphine for opioid use disorder (MOUD). It is observed that up to 68% of people with MOUD have chronic pain condition. Therefore, a large number of people taking methadone or buprenorphine will suffer from chronic pain, but they frequently face limited availability of clinicians offering non-pharmacological pain management programs. Thus, a brief internet-based pain relief skills program may be one option that can overcome such treatment barrier. A recent randomized control trial on patients with chronic low back pain has demonstrated that a single-session, 2-hour, pain management class (Empowered Relief; ER) was effective to improve pain and pain-related distress. The ER class consists of pain neuroscience education and self-regulatory skills. While the ER is a promising and scalable option, it is not yet tested in patients with chronic pain who take methadone or buprenorphine. The current proposed, single-arm, uncontrolled pilot project will determine a) a feasibility in this patient population, b) patients' perceptions and satisfaction of the ER class and c) preliminary efficacy to inform the design of a future, larger, controlled trial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age at least 18 years old
  • Chronic Pain (> 3 months)
  • Taking Methadone or Buprenorphine
  • English Fluency

排除标准

  • Pregnant,
  • Gross Cognitive Impairment,
  • Acute Suicidality,
  • Severe Depression

结局指标

主要结局

Perceived Usefulness

时间窗: once immediately after class

How useful was the information presented in the class? (a single item, 0-10 scale, higher scores correspond to greater perceived usefulness).

Participant Satisfaction

时间窗: once immediately after class

Please rate your overall satisfaction with the class (a Single Item, 0-10 Scale, higher scores correspond to greater satisfaction).

Likelihood of Using the Skills

时间窗: once immediately after class

How likely are you to use the skills and information you learned? (a Single Item, 0-10 Scale, higher scores correspond to greater likelihood)

次要结局

  • Pain Bothersomeness(At 1 month post-tx)
  • PCS Total Scores(At 1 month post-tx)
  • Pain Intensity(At 1 month post-tx)
  • PROMIS-Sleep Disturbance(At 1 month post-tx)

研究者

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

Beth Darnall

Professor

Stanford University

研究点 (2)

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