Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients

NCT ID: NCT06003010

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Study group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Yoga group

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

Group Type: EXPERIMENTAL

Yoga

Intervention Type: BEHAVIORAL

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

Interventions

Yoga

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pediatric Orthopaedic Society of North America

OTHER

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dell Children's Medical Center

Austin, Texas, United States

Countries

United States

Other Identifiers

STUDY00003670

Identifier Type: -

Identifier Source: org_study_id