Yoga in the Treatment of Adolescent Idiopathic and Degenerative Scoliosis
Primary Purpose
Scoliosis, Scoliosis Idiopathic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga poses
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis
Eligibility Criteria
Inclusion Criteria:
- Scoliosis
- Willingness to do pose at least once daily for 4 -10 months
- Willingness to have a second X-ray 4-10 months after starting to do pose
Exclusion Criteria:
- Neuromuscular disease
- Previous Spinal surgery
- Pregnancy
Sites / Locations
- Manhattan Physical Medicine and Rehabilitation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental arm
Arm Description
Patients will have an X-ray before beginning to do one or two yoga poses daily for 4 - 10 months. After that period, they will have a second X-ray.
Outcomes
Primary Outcome Measures
Change in Cobb angle
Baseline scoliotic curve - scoliotic curve measured after treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT03110965
First Posted
April 7, 2017
Last Updated
August 23, 2022
Sponsor
Manhattan Physical Medicine and Rehabilitation, LLP
1. Study Identification
Unique Protocol Identification Number
NCT03110965
Brief Title
Yoga in the Treatment of Adolescent Idiopathic and Degenerative Scoliosis
Official Title
Yoga in the Treatment of Adolescent Idiopathic and Degenerative Scoliosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Manhattan Physical Medicine and Rehabilitation, LLP
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
The effect of two isometric exercises is measured on Cobb angles from films taken 4-10 months apart.
Detailed Description
The investigators obtained baseline Cobb angles on simple and complex curves, and collected previous, earlier studies of each adolescent idiopathic and degenerative scoliosis patient. The investigators then taught them to do the side-plank pose with the convex side of lumbar and thoracolumbar scoliotic curves downward, and a slightly altered version of the the half moon pose of yoga with the convex side of thoracic and cervicothoracic curves downward. The half moon pose was altered in that a belt was looped around the horizontal leg's foot, and held in a vertically extended upper arm's hand, and pulled tightly in that vertical position.
Each pose was held as long as the patient could at least once daily.
Cobb angles were again measured in films taken 4-10 months later.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis, Scoliosis Idiopathic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Patient's change in previous X-ray compared with baseline, and baseline compared with X-ray done 4-10 months later
Masking
None (Open Label)
Masking Description
Radiologists are unaware of study.
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Patients will have an X-ray before beginning to do one or two yoga poses daily for 4 - 10 months. After that period, they will have a second X-ray.
Intervention Type
Behavioral
Intervention Name(s)
Yoga poses
Intervention Description
Patients are asked to perform one or two yoga poses daily for 4-10 months
Primary Outcome Measure Information:
Title
Change in Cobb angle
Description
Baseline scoliotic curve - scoliotic curve measured after treatment
Time Frame
4 - 10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Scoliosis
Willingness to do pose at least once daily for 4 -10 months
Willingness to have a second X-ray 4-10 months after starting to do pose
Exclusion Criteria:
Neuromuscular disease
Previous Spinal surgery
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loren M Fishman, MD
Organizational Affiliation
Columbia Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Physical Medicine and Rehabilitation
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Yoga in the Treatment of Adolescent Idiopathic and Degenerative Scoliosis
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