ScoliosisNCT03110965
Yoga in the Treatment of Adolescent Idiopathic and Degenerative Scoliosis
A study testing Yoga poses in people with Scoliosis and Scoliosis Idiopathic, run by Manhattan Physical Medicine and Rehabilitation, LLP at 1 site in United States.
Trial summary
The effect of two isometric exercises is measured on Cobb angles from films taken 4-10 months apart. Read more about this study
- Who is it for?
- Ages 6 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis, Scoliosis Idiopathic
- What is being tested?
- Yoga poses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2015to 1 Jan 2019
- 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 6 to 105 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Neuromuscular disease
- Previous Spinal surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Physical Medicine and Rehabilitation
New York, New York, 10022
About this study
The effect of two isometric exercises is measured on Cobb angles from films taken 4-10 months apart.
Read the 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.
- Conditions
- Scoliosis, Scoliosis Idiopathic
- Being tested
- Yoga poses
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga posesBehavioural
Patients are asked to perform one or two yoga poses daily for 4-10 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Yoga poses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cobb angle
Baseline scoliotic curve - scoliotic curve measured after treatment
Measured: 4 - 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 Jan 2015
- Primary completion1 Mar 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manhattan Physical Medicine and Rehabilitation, LLP
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loren M. Fishman,MD, Columbia University
- Investigators
- Loren M Fishman, MD, Principal investigator, Columbia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110965
- Sponsor's protocol ID
- MANHATTANPMR
- Status last verified
- Aug 2022
- First submitted
- 7 Apr 2017
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga in the Treatment of Adolescent Idiopathic and Degenerative Scoliosis
- ClinicalTrials.gov ID
- NCT03110965
- Acronym / sponsor ID
- MANHATTANPMR
- Conditions
- Scoliosis, Scoliosis Idiopathic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Manhattan Physical Medicine and Rehabilitation, LLPUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 12 Apr 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patient's change in previous X-ray compared with baseline, and baseline compared with X-ray done 4-10 months later
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Behavioral: Yoga posesPatients 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. |
Who may qualify
- Ages
- 6 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Neuromuscular disease
- Previous Spinal surgery
- Pregnancy
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 |
|---|---|---|
| Yoga posesPatients are asked to perform one or two yoga poses daily for 4-10 months | Behavioural | Experimental arm |
Primary outcome
Change in Cobb angle
Time frame: 4 - 10 months
Baseline scoliotic curve - scoliotic curve measured after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Scoliosis
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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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.
Loren M Fishman, MD principal investigator
Columbia Medical School
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 poses in people with Scoliosis and Scoliosis Idiopathic, run by Manhattan Physical Medicine and Rehabilitation, LLP 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 3 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: finished, as of the sponsor's last update on 26 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Cobb angle (time frame: 4 - 10 months). 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 26 Aug 2022.