Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients

Sponsor
University of Texas at Austin (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06003010
Collaborator
Pediatric Orthopaedic Society of North America (Other)
40
1
2
6
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Yoga
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Efficacy of Perioperative Yoga at Reducing Pain in Surgical AIS Patients
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Morphine Equivalent Units [7 weeks]

    Number of narcotics taken after surgery

  2. Time to first ambulation [1 week]

    How long it takes patient to walk after surgery

  3. Length of hospital stay [1 week]

    How long before the patient was discharged after surgery

  4. Return to school/activities [7 weeks]

    How long before the patient returned to school/activities after surgery

  5. Pain scores [14 weeks]

    Pain scores before and various times after surgery using Faces Pain Scale-Revised

Secondary Outcome Measures

  1. Compliance with yoga videos [14 weeks]

    How often patients did yoga videos via patient recorded log and YouTube Analytics

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dell Children's Medical Center Austin Texas United States 78731

Sponsors and Collaborators

  • University of Texas at Austin
  • Pediatric Orthopaedic Society of North America

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT06003010
Other Study ID Numbers:
  • STUDY00003670
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 24, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2023