Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients

Not Applicable

Not yet recruiting

• Conditions: Adolescent Idiopathic Scoliosis; Spinal Fusion
• Interventions: Behavioral: Yoga

• Registration Number: NCT06003010
• Lead Sponsor: University of Texas at Austin

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-16
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-21
• Last Update Submitted: 2023-08-29
• Study Start: 2023-09
• Last Update Posted: 2023-09-01
• Primary Completion: 2023-12
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Idiopathic Scoliosis patients
• English speaking patient and parents

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga group	Yoga	This group will be asked to do a 6 week series of yoga videos at home pre- and post-surgery.

Primary Outcome Measures

Name	Time	Method
Morphine Equivalent Units	7 weeks	Number of narcotics taken after surgery
Length of hospital stay	1 week	How long before the patient was discharged after surgery
Time to first ambulation	1 week	How long it takes patient to walk after surgery
Return to school/activities	7 weeks	How long before the patient returned to school/activities after surgery
Pain scores	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.

Secondary Outcome Measures

Name	Time	Method
Compliance with yoga videos	14 weeks	How often patients did yoga videos via patient recorded log and YouTube Analytics

Trial Locations

Locations (1)

Dell Children's Medical Center; 🇺🇸 Austin, Texas, United States