Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

Efficacy of Perioperative Yoga at Reducing Pain in Surgical AIS Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06003010
• Other study ID #: STUDY00003670
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: March 2024

Study information

• Verified date: August 2023
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis
• Spinal Fusion

Intervention

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

Locations

Country	Name	City	State
United States	Dell Children's Medical Center	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	Pediatric Orthopaedic Society of North America

Country where clinical trial is conducted

United States, 

Outcome

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