Can Distraction Substitute for Procedural Sedation and Improve Tolerance in Patients Receiving Epidural Steroid Injection for Pain? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Pain Score During Procedure
研究概览
简要总结
This study examines the impact of virtual reality compared to sedation (midazolam and/or fentanyl) and no intervention on pain experienced from an epidural steroid injection (ESI). The intervention group (who receive virtual reality as a distraction modality) is compared to a sedation group and a control group.
详细描述
All patients enrolled in the study will already be undergoing lumbar epidural steroid injections for lumbar radicular pain as part of their clinical care. The epidural approach will either be transforaminal or interlaminar depending on clinical judgment (i.e. transforaminal ESI for unilateral pain, interlaminar ESI for bilateral pain). The study will consist of 3 groups: virtual reality, sedation, and a control group which receives no intervention (i.e. standard of care). The virtual reality group will receive virtual reality via a headset containing a menu of 6 programs that the subject can choose; the sedation group will receive from 1-5 mg of midazolam and up to 150 mcg of fentanyl as clinically indicated, and the control group will not receive an intervention (standard of care). All subjects will also receive 1% lidocaine local anesthetic through a 25-gauge needle for superficial anesthesia, which is standard of care. Subjects will be randomized to each of these groups, with sub-allocation being done stratified by the type of ESI (transforaminal vs. interlaminar).
A secondary pilot study will evaluate whether a processed electroencephalogram (pEEG) and continuous colored density spectral array monitored via a four-channel Masimo SEDLine frontal EEG sensor can serve as a biomarker for painful stimulation and the effectiveness of distraction and sedation to reduce acute pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor will be unaware of treatment allocation but the patient and provider cannot be.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females; ages 18-90 years
- •Lumbosacral radicular pain with a baseline average of leg pain score of > 4/10, MRI findings (if available) consistent with symptoms, duration of pain > 6 weeks, and no previous lumbar spine surgery.
- •Documented diagnosis of radicular pain caused by herniated disc, central stenosis, foraminal stenosis, degenerative disk disease
- •Willingness to adhere to undergo ESI with either sedation (midazolam and or fentanyl) or with virtual reality
- •Able to appear for a follow up visit between 24-40 days following the intervention
排除标准
- •MRI findings discordant with symptoms (absence of herniated disc, spinal stenosis or severe disc degeneration without nerve root impingement (e.g. annular tears) that could explain symptoms)
- •Previous lumbosacral spine surgery at the area affected
- •Prior ESI within the past 6 months
- •Allergy to contrast dye
- •Poorly controlled psychiatric conditions that could affect outcomes (e.g. active substance abuse) or impose a barrier to participation (e.g. anxiety disorder requiring procedural sedation)
- •Morbid obesity (BMI >40)
研究组 & 干预措施
Virtual reality (VR)
Subjects in the VR group will be fitted with an HTC headset and headphones with disposable ear covers. They will choose from a menu of 6 different programs. They will also receive 1% superficial anesthesia.
干预措施: Virtual reality (Device)
Sedation
Conscious sedation will be accomplished by the use of midazolam and/ or fentanyl. We will use a wide range of dosing (1-5 mg for midazolam, up to 150 mcg for fentanyl) to maximize generalizability and account for widespread variability in clinical circumstances, medical practice and patient response (personalized medicine). All medications will be titrated to conscious sedation by a board-certified anesthesiologist. Subjects will also receive 1% superficial anesthesia.
干预措施: Intravenous sedation (Drug)
Standard care
Patients in this arm will be administered only 1% lidocaine as superficial anesthesia, similar to the other 2 arms.
干预措施: Standard care (Other)
结局指标
主要结局
Pain Score During Procedure
时间窗: Immediately after procedure
0-10 verbal rating scale (higher scores indicate greater pain)
次要结局
- Amount of Local Anesthetic Required(At the start of the procedure)
- Subcutaneous Skin Wheal Pain Score(Immediately after skin wheal)
- Procedure Satisfaction(In postanesthetic care unit (within 1 hour))
- Ability to Communicate(In postanesthetic care unit (within 1 hour))
- Procedure-related Anxiety(In postanesthetic care unit (within 1 hour))
- Time to Discharge From Postanesthetic Care Unit(At discharge from postanesthetic care unit assessed up to 6 hours)
- Participants With Positive Categorical Outcome(4 weeks)
- Average Leg Pain Score(4 weeks)
- Worst Leg Pain Score(4 weeks)
- Average Back Pain Score(4 weeks)
- Worst Back Pain Score(4 weeks)
- Patient Global Impression of Change (PGIC)(4 weeks)
- Number of Participants With Analgesic Reduction(4 weeks)
- Oswestry Disability Index (ODI) Score(4 weeks)
- Hospital Anxiety and Depression Scale (HADS) Scores for Anxiety and Depressions(4 weeks)
- Number of Participants With Complications(4 weeks)
- Percentage Change of the Spectral Edge Frequency (SEF)(During the procedure for up to 20 minutes)
- Hospital Anxiety and Depression Scale (HADS) Scores for Depression and Anxiety(4 weeks)