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Not yet recruitingNCT06003010Updated Sep 1, 2023

Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients

An interventional study of Yoga in Adolescent Idiopathic Scoliosis and Spinal Fusion, sponsored by University of Texas at Austin. Not yet recruiting at 1 site in United States. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-01.

Sponsored by University of Texas at Austin · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Adolescent Idiopathic Scoliosis
  • Spinal Fusion

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03

In context

Scoliosis

594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.

This study's planned enrollment of 40 is close to the median of 44 across 344 interventional studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

University of Texas at Austin is the lead sponsor of 319 studies on the registry; 78 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Idiopathic Scoliosis patients
  • English speaking patient and parents

Exclusion criteria

Exclusion Criteria:

  • Non idiopathic scoliosis diagnosis
  • no access to internet or computer
  • non-English speaking parents and/or patient
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

Interventions

  • BehavioralYoga

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

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What researchers measure

Primary outcomes

  1. Morphine Equivalent Units

    Number of narcotics taken after surgery

    Time frame: 7 weeks

  2. Time to first ambulation

    How long it takes patient to walk after surgery

    Time frame: 1 week

  3. Length of hospital stay

    How long before the patient was discharged after surgery

    Time frame: 1 week

  4. Return to school/activities

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

    Time frame: 7 weeks

  5. 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.

    Time frame: 14 weeks

Secondary outcomes

  1. Compliance with yoga videos

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

    Time frame: 14 weeks

07

Study locations

1 site
  • Dell Children's Medical Center
    Austin, Texas 78731, United States
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06003010
Lead sponsor
University of Texas at Austin
Collaborators
Pediatric Orthopaedic Society of North America
Responsible party
Sponsor
First posted
Aug 21, 2023
Start date
Sep 2023 (estimated)
Primary completion
Dec 2023 (estimated)
Completion
Mar 2024 (estimated)
Last update
Sep 1, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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