Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients

Efficacy of Perioperative Yoga at Reducing Pain in Surgical AIS Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adolescent Idiopathic Scoliosis; Spinal Fusion
• Intervention / Treatment: Behavioral: Yoga

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78731
      • Dell Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Study group; This group will be given standard pre- and post-surgery movement instructions.
Experimental: Yoga group; This group will be asked to do a 6 week series of yoga videos at home pre- and post-surgery.	Behavioral: Yoga; 6 yoga videos to be done 2-3x a week for 6 weeks before and after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine Equivalent Units	Number of narcotics taken after surgery	7 weeks
Time to first ambulation	How long it takes patient to walk after surgery	1 week
Length of hospital stay	How long before the patient was discharged after surgery	1 week
Return to school/activities	How long before the patient returned to school/activities after surgery	7 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance with yoga videos	How often patients did yoga videos via patient recorded log and YouTube Analytics	14 weeks

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: Pediatric Orthopaedic Society of North America

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: STUDY00003670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All participants will be assigned a study number. Any identifiable information will be stored separately from study data and will only be accessed by authorized team members.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No