NCT03110965

Brief Summary

The effect of two isometric exercises is measured on Cobb angles from films taken 4-10 months apart.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

April 7, 2017

Last Update Submit

August 23, 2022

Conditions

ScoliosisScoliosis Idiopathic

Outcome Measures

Primary Outcomes (1)

  • Change in Cobb angle

    Baseline scoliotic curve - scoliotic curve measured after treatment

    4 - 10 months

Study Arms (1)

Experimental arm

EXPERIMENTAL

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.

Behavioral: Yoga poses

Interventions

Yoga posesBEHAVIORAL

Patients are asked to perform one or two yoga poses daily for 4-10 months

Experimental arm

Eligibility Criteria

Age6 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Neuromuscular disease
  • Previous Spinal surgery
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manhattan Physical Medicine and Rehabilitation

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Loren M Fishman, MD

    Columbia Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Radiologists are unaware of study.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Patient's change in previous X-ray compared with baseline, and baseline compared with X-ray done 4-10 months later
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 12, 2017

Study Start

January 1, 2015

Primary Completion

March 1, 2018

Study Completion

January 1, 2019

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)