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临床试验/NCT02674711
NCT02674711已完成不适用

The Effect of a Brief Pre-operative Pain Medication Educational Video on Post-operative Prescription Opioid Medication Use in Patients Undergoing Spine Surgery. A Randomized Controlled Trial

Brooke Army Medical Center2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Number of Opioid Medication Prescriptions

研究概览

简要总结

The purpose of this project is to assess the impact of an educational video on the use of prescription opioid medication during a 6-month period following spine surgery. Subjects will be recruited from the pool of patients coming in for the pre-operative appointment prior to spine surgery. Patients that consent and enroll will be randomized to receive either a brief educational video at this appointment or usual care. Patients will be followed after surgery weekly for the first month, and then again at 6 months to determine their prescription opioid medication utilization patterns. Prescription data will also be pulled from electronic medical records.

详细描述

After consenting, meeting inclusion criteria, and enrollment, all participants will complete several standard self-report questionnaires related to medical history, social demographic, and psychosocial variables that are related to low back pain, and often used in clinics that manage patients with low back pain. They will then be randomized to either receive the education, or only usual care (which is the typical information the surgeon provides the patient verbally during the pre-operative appointment). All patients will receive the usual care education from their surgeon.

Education Group:

The educational video is a white board style patient-centric video. The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer on-acute pain. It also discusses some of the dangers of long-term opioid usage.

All Subjects:

All subjects will receive the usual care education that is typically given by their surgeon. That will be left up to the discretion of each surgeon.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently scheduled for a pre-operative appointment with an orthopaedic spine surgeon or neurosurgeon specifically for a lumbar surgery.
  • Surgery is taking place for a condition that has been ongoing for 6 months or longer (chronic)
  • Between the age of 18 - 65 years
  • Read and speak English well enough to understand the education, provide informed consent and follow study instructions

排除标准

  • a. Known aversion or allergy that would prevent the patient from taking any opioid based pain medication

结局指标

主要结局

Number of Opioid Medication Prescriptions

时间窗: 12 months

Number of prescriptions within 12 months after surgery

次要结局

  • Numeric Pain Rating Scale (NPRS)(6 months)
  • Modified Oswestry Disability Index (ODI) or Neck Disability Index (NDI)(6 months)

研究者

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

Dan Rhon

Director of Physical Therapy, Center for the Intrepid

Brooke Army Medical Center

研究点 (2)

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