Clinical trial NCT06003010: Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients
Official title: Efficacy of Perioperative Yoga at Reducing Pain in Surgical AIS Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Spinal Fusion
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Pediatric Orthopaedic Society of North America
First posted: 2023-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Morphine Equivalent Units
timeFrame: 7 weeks
measure: Time to first ambulation
timeFrame: 1 week
measure: Length of hospital stay
timeFrame: 1 week
measure: Return to school/activities
timeFrame: 7 weeks
measure: Pain scores
timeFrame: 14 weeks
Secondary outcomes:
measure: Compliance with yoga videos
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
Study officials:
References: