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临床试验/NCT06003010
NCT06003010尚未招募不适用

Efficacy of Perioperative Yoga at Reducing Pain in Surgical AIS Patients

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
2
主要终点
Time to first ambulation

研究概览

简要总结

Adolescent Idiopathic Scoliosis (AIS) is defined as a three-dimensional lateral deformity of the spine. It is described with a cobb angle of greater than 10 degrees. There is no known etiology of AIS. Once the degrees of curvature become severe (greater than 45 degrees), surgical intervention (posterior spinal fusion - PSF) is often discussed. Most adolescent patients and their families opt for surgical correction to decrease future complications of severe scoliosis, such as decreased vital capacity of the lungs, potential future activity restrictions, cosmetic appearance, and self-esteem. While the patient and family are eager to undergo PSF, they do have concerns. The major concerns are pain control and their ability to return to activities.

In current literature, there are many studies completed regarding pharmacologic pain control management with the use of IV patient-controlled analgesia (PCA) with opioids, narcotics, non-steroidal anti-inflammatories, muscle relaxers, Tylenol, and gabapentin. However, there is not a well-established multimodal pain management plan for postoperative PSF patients. There is also no current literature discussing nonpharmacologic pain management methods, such as stretching, strengthening and yoga, for patients undergoing PSF. There are multiple studies discussing core stabilization used for helping AIS patients non-operatively. There is no literature discussing the use of nonpharmacologic pain management methods for improved pain control (including decreased use of pharmacologic agents) and quicker return to activities.

The aim of this study is to determine if patients with AIS undergoing PSF require fewer pain medications and have an earlier return to activities if completing a yoga program six weeks prior to their surgery.

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
None

入排标准

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

入选标准

  • Idiopathic Scoliosis patients
  • English speaking patient and parents

排除标准

  • Non idiopathic scoliosis diagnosis
  • no access to internet or computer
  • non-English speaking parents and/or patient

结局指标

主要结局

Time to first ambulation

时间窗: 1 week

How long it takes patient to walk after surgery

Return to school/activities

时间窗: 7 weeks

How long before the patient returned to school/activities after surgery

Morphine Equivalent Units

时间窗: 7 weeks

Number of narcotics taken after surgery

Pain scores

时间窗: 14 weeks

Pain scores before and various times after surgery using Faces Pain Scale-Revised. Range is from 0-10. 10 being most severe pain.

Length of hospital stay

时间窗: 1 week

How long before the patient was discharged after surgery

次要结局

  • Compliance with yoga videos(14 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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