Adolescent Idiopathic Scoliosis Clinical Trial
Official title:
Efficacy of Perioperative Yoga at Reducing Pain in Surgical AIS Patients
Verified date | August 2023 |
Source | University of Texas at Austin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | March 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | Inclusion Criteria: - Idiopathic Scoliosis patients - English speaking patient and parents Exclusion Criteria: - Non idiopathic scoliosis diagnosis - no access to internet or computer - non-English speaking parents and/or patient |
Country | Name | City | State |
---|---|---|---|
United States | Dell Children's Medical Center | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas at Austin | Pediatric Orthopaedic Society of North America |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morphine Equivalent Units | Number of narcotics taken after surgery | 7 weeks | |
Primary | Time to first ambulation | How long it takes patient to walk after surgery | 1 week | |
Primary | Length of hospital stay | How long before the patient was discharged after surgery | 1 week | |
Primary | Return to school/activities | How long before the patient returned to school/activities after surgery | 7 weeks | |
Primary | Pain scores | Pain scores before and various times after surgery using Faces Pain Scale-Revised. Range is from 0-10. 10 being most severe pain. | 14 weeks | |
Secondary | Compliance with yoga videos | How often patients did yoga videos via patient recorded log and YouTube Analytics | 14 weeks |
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