Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients

NCT06003010 | Unknown

• 1 other identifier: STUDY00003670
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis; Spinal Fusion

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Compliance with yoga videos

  14 weeks

Study Arms (2)

Study group

NO INTERVENTION

This group will be given standard pre- and post-surgery movement instructions.

Yoga group

EXPERIMENTAL

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

Behavioral: Yoga

Interventions

Yoga BEHAVIORAL

6 yoga videos to be done 2-3x a week for 6 weeks before and after surgery.

Yoga group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Idiopathic Scoliosis patients
• English speaking patient and parents

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead
• Pediatric Orthopaedic Society of North America: collaborator

Study Sites (1)

Dell Children's Medical Center

Austin, Texas, 78731, United States

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: August 21, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)