Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients
Primary Purpose
Adolescent Idiopathic Scoliosis, Spinal Fusion
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
About this trial
This is an interventional supportive care trial for Adolescent Idiopathic Scoliosis
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
Sites / Locations
- Dell Children's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Study group
Yoga group
Arm Description
This group will be given standard pre- and post-surgery movement instructions.
This group will be asked to do a 6 week series of yoga videos at home pre- and post-surgery.
Outcomes
Primary Outcome Measures
Morphine Equivalent Units
Number of narcotics taken after surgery
Time to first ambulation
How long it takes patient to walk after surgery
Length of hospital stay
How long before the patient was discharged after surgery
Return to school/activities
How long before the patient returned to school/activities after surgery
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.
Secondary Outcome Measures
Compliance with yoga videos
How often patients did yoga videos via patient recorded log and YouTube Analytics
Full Information
NCT ID
NCT06003010
First Posted
February 16, 2023
Last Updated
August 29, 2023
Sponsor
University of Texas at Austin
Collaborators
Pediatric Orthopaedic Society of North America
1. Study Identification
Unique Protocol Identification Number
NCT06003010
Brief Title
Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients
Official Title
Efficacy of Perioperative Yoga at Reducing Pain in Surgical AIS Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
Collaborators
Pediatric Orthopaedic Society of North America
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis, Spinal Fusion
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
No Intervention
Arm Description
This group will be given standard pre- and post-surgery movement instructions.
Arm Title
Yoga group
Arm Type
Experimental
Arm Description
This group will be asked to do a 6 week series of yoga videos at home pre- and post-surgery.
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
6 yoga videos to be done 2-3x a week for 6 weeks before and after surgery.
Primary Outcome Measure Information:
Title
Morphine Equivalent Units
Description
Number of narcotics taken after surgery
Time Frame
7 weeks
Title
Time to first ambulation
Description
How long it takes patient to walk after surgery
Time Frame
1 week
Title
Length of hospital stay
Description
How long before the patient was discharged after surgery
Time Frame
1 week
Title
Return to school/activities
Description
How long before the patient returned to school/activities after surgery
Time Frame
7 weeks
Title
Pain scores
Description
Pain scores before and various times after surgery using Faces Pain Scale-Revised. Range is from 0-10. 10 being most severe pain.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Compliance with yoga videos
Description
How often patients did yoga videos via patient recorded log and YouTube Analytics
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Dell Children's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients
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