Adolescent Idiopathic ScoliosisNCT06003010
Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients
A study testing Yoga in people with Adolescent Idiopathic Scoliosis and Spinal Fusion, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Spinal Fusion
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2023to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Idiopathic Scoliosis patients
- English speaking patient and parents
Who cannot join
- Non idiopathic scoliosis diagnosis
- no access to internet or computer
- non-English speaking parents and/or patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Perioperative Yoga at Reducing Pain in Surgical AIS Patients
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.
- Conditions
- Adolescent Idiopathic Scoliosis, Spinal Fusion
- Being tested
- Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
6 yoga videos to be done 2-3x a week for 6 weeks before and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Study group | No intervention | This group will be given standard pre- and post-surgery movement instructions. |
| Yoga group | Experimental | This group will be asked to do a 6 week series of yoga videos at home pre- and post-surgery. Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Equivalent Units
Number of narcotics taken after surgery
Measured: 7 weeks
Time to first ambulation
How long it takes patient to walk after surgery
Measured: 1 week
Length of hospital stay
How long before the patient was discharged after surgery
Measured: 1 week
Return to school/activities
How long before the patient returned to school/activities after surgery
Measured: 7 weeks
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.
Measured: 14 weeks
Secondary outcomes (1)
Compliance with yoga videos
How often patients did yoga videos via patient recorded log and YouTube Analytics
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Orthopaedic Society of North America
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003010
- Sponsor's protocol ID
- STUDY00003670
- Status last verified
- Aug 2023
- First submitted
- 16 Feb 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Perioperative Yoga at Reducing Pain in Surgical AIS Patients
- ClinicalTrials.gov ID
- NCT06003010
- Acronym / sponsor ID
- STUDY00003670
- Conditions
- Adolescent Idiopathic Scoliosis, Spinal Fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Pediatric Orthopaedic Society of North America
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | No intervention | –This group will be given standard pre- and post-surgery movement instructions. |
| Yoga group | Experimental | Behavioral: YogaThis group will be asked to do a 6 week series of yoga videos at home pre- and post-surgery. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Idiopathic Scoliosis patients
- English speaking patient and parents
Key exclusion criteria (3 listed)
- Non idiopathic scoliosis diagnosis
- no access to internet or computer
- non-English speaking parents and/or patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga6 yoga videos to be done 2-3x a week for 6 weeks before and after surgery. | Behavioural | Yoga group |
Primary outcome
Morphine Equivalent Units
Time frame: 7 weeks
Number of narcotics taken after surgery
Time to first ambulation
Time frame: 1 week
How long it takes patient to walk after surgery
Length of hospital stay
Time frame: 1 week
How long before the patient was discharged after surgery
Return to school/activities
Time frame: 7 weeks
How long before the patient returned to school/activities after surgery
Pain scores
Time frame: 14 weeks
Pain scores before and various times after surgery using Faces Pain Scale-Revised. Range is from 0-10. 10 being most severe pain.
1 secondary outcome
Compliance with yoga videos
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Adolescent Idiopathic Scoliosis and Spinal Fusion, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Equivalent Units (time frame: 7 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.