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Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis

Primary Purpose

Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis; Lumbar Region

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Botulinum toxin type A

Isometric Yoga-like exercise

Placebo

About this trial

This is an interventional treatment trial for Scoliosis Idiopathic focused on measuring Adolescent idiopathic scoliosis, scoliosis, yoga, isometric, botulinum

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1. Fourteen - 18 years of age, 2. Scoliotic curve greater than 25 degrees, less than 45 degrees, 3. Stated willingness to do the yoga and yoga-like poses daily, 4. Written, signed consent by patient and parent/guardian 5. Pre-test Cobb films no less than 3 months old read by independent radiologists.

Exclusion Criteria:
1. Neurological, muscular or neuromuscular disease, (e.gs., cerebral palsy, myopathy, stroke),
2. Genetic abnormalities that affect limb growth, proportionality or metabolism, (e.gs., mucopolysaccharidoses, Marfan's syndrome, Refsums disease).
3. Pregnancy and other conditions prohibiting X-rays or minute(s)-long exertion (e.gs., congestive heart failure, great weakness, COPD).
4. Previous exposure to botulinum neurotoxin Type A. Sexually active female subjects must present a recent negative pregnancy test.

Sites / Locations

Manhattan Physical Medicine and Rehabilitation, PLLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Placebo Comparator

Active Comparator

Arm Label

Group I: Placebo isometric measure, no injection

Group II Isometric yoga-like exercise, placebo injection given

Group III: True isometric exercise, botulinum injection

Crossover

Arm Description

Group I: no isometric yoga-like exercise, no injection given.

Group II isometric yoga-like exercise, injection of preservative-free normal saline.

Group III: Isometric yoga-like exercise, botulinum injection given

After the three months, Arm I and Arm II patients will be given botulinum injections, and Group I will be given the proper yoga-like exercise. These two arms will constitute a further comparator with their own performances in the first 3 months of the study.

Outcomes

Primary Outcome Measures

Reduction in lumbar and thoracic scoliotic curve

Measured by the Cobb angle in coronal X-rays

Reduction in lumbar and thoracic scoliotic curve

Measured by the Cobb angle in coronal X-rays

Reduction in lumbar and thoracic scoliotic curve

Measured by the Cobb angle in coronal X-rays

Reduction in lumbar and thoracic scoliotic curve

Measured by the Cobb angle in coronal X-rays

Reduction in lumbar and thoracic scoliotic curve

Measured by the Cobb angle in coronal X-rays

Secondary Outcome Measures

Full Information

NCT ID

NCT04922983

First Posted

April 3, 2021

Last Updated

October 17, 2023

Sponsor

Manhattan Physical Medicine and Rehabilitation, LLP

1. Study Identification

Unique Protocol Identification Number

NCT04922983

Brief Title

Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis

Official Title

Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2021 (Actual)

Primary Completion Date

July 1, 2025 (Anticipated)

Study Completion Date

January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Manhattan Physical Medicine and Rehabilitation, LLP

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study uses a yoga-like isometric posture and botulinum injections to reduce the curves in adolescent idiopathic lumbar scoliosis. Three previous studies show that the yoga pose is effective for reversing scoliotic curves; Botulinum toxin has been approved by the FDA for teenagers. However, no studies using the two of them together have been done until this one.

Detailed Description

The randomized control 6-month study employs an isometric yoga-like posture to strengthen the weak side, and one set of botulinum injections to weaken the strong side of adolescent idiopathic lumbar scoliosis between 25 and 60 degrees. It is open to people between 12 and 18 years of age who are willing to do the pose every day for three months. This is a crossover study: After 3 months, every patient who was placebo will be offered the actual proven yoga pose and botulinum toxin injections. Two additional free X-rays at 3 weeks and 3 months following the botulinum injection will also be available to each placebo patient. In this way every patient - placebo or not - will receive the full proper treatment within 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis; Lumbar Region

Keywords

Adolescent idiopathic scoliosis, scoliosis, yoga, isometric, botulinum

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

Three groups: Group I: Placebo isometric measure, no injection Group II True isometric exercise, placebo injection Group III: True isometric exercise, botulinum injection

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Participants will understand they may receive placebo, and that they will not be told Investigators will know whether they give injections or not, but will not know if injection is placebo. Outcomes assessors will be blinded to the entire procedure (radiologists reading X-rays).

Allocation

Randomized

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group I: Placebo isometric measure, no injection

Arm Type

Sham Comparator

Arm Description

Group I: no isometric yoga-like exercise, no injection given.

Arm Title

Group II Isometric yoga-like exercise, placebo injection given

Arm Type

Placebo Comparator

Arm Description

Group II isometric yoga-like exercise, injection of preservative-free normal saline.

Arm Title

Group III: True isometric exercise, botulinum injection

Arm Type

Active Comparator

Arm Description

Group III: Isometric yoga-like exercise, botulinum injection given

Arm Title

Crossover

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Botulinum toxin type A

Other Intervention Name(s)

Incobotulinumtoxin A

Intervention Description

A position similar to the side-plank (Vasisthasana) held for maximal time at least once daily (usual duration: 30 - 90 seconds).

Intervention Type

Behavioral

Intervention Name(s)

Isometric Yoga-like exercise

Other Intervention Name(s)

Side-Plank, Vasisthasana

Intervention Description

Extended torso and legs held diagonally by one straight arm, back against wall if necessary

Intervention Type

Behavioral

Intervention Name(s)

Placebo

Other Intervention Name(s)

no active intervention by drug or yoga-like exercise

Intervention Description

Used as placebo

Primary Outcome Measure Information:

Title

Reduction in lumbar and thoracic scoliotic curve

Description

Measured by the Cobb angle in coronal X-rays

Time Frame

At study onset

Title

Reduction in lumbar and thoracic scoliotic curve

Description

Measured by the Cobb angle in coronal X-rays

Time Frame

3 weeks after study onset

Title

Reduction in lumbar and thoracic scoliotic curve

Description

Measured by the Cobb angle in coronal X-rays

Time Frame

3 months after study onset

Title

Reduction in lumbar and thoracic scoliotic curve

Description

Measured by the Cobb angle in coronal X-rays

Time Frame

3 weeks after crossover group injections

Title

Reduction in lumbar and thoracic scoliotic curve

Description

Measured by the Cobb angle in coronal X-rays

Time Frame

3 months after crossover group injections

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. Fourteen - 18 years of age, 2. Scoliotic curve greater than 25 degrees, less than 45 degrees, 3. Stated willingness to do the yoga and yoga-like poses daily, 4. Written, signed consent by patient and parent/guardian 5. Pre-test Cobb films no less than 3 months old read by independent radiologists. Exclusion Criteria: Neurological, muscular or neuromuscular disease, (e.gs., cerebral palsy, myopathy, stroke), Genetic abnormalities that affect limb growth, proportionality or metabolism, (e.gs., mucopolysaccharidoses, Marfan's syndrome, Refsums disease). Pregnancy and other conditions prohibiting X-rays or minute(s)-long exertion (e.gs., congestive heart failure, great weakness, COPD). Previous exposure to botulinum neurotoxin Type A. Sexually active female subjects must present a recent negative pregnancy test.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Loren M Fishman, MD

Phone

646-642-0700

lorenmartinfishman@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Cara M Cipriano, BA

Phone

(2120 472-0077

Cara@sciatica.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Loren M Fishman

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Manhattan Physical Medicine and Rehabilitation, PLLC

City

Manhattan

State/Province

New York

ZIP/Postal Code

10022

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cara Cipriano, BA, MA

Phone

212-472-0077

carampmr@gmail.com

First Name & Middle Initial & Last Name & Degree

Loren Fishman, MD

Phone

646-642-0700

loren@sciatica.org

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25568820

Citation

Fishman LM, Groessl EJ, Sherman KJ. Serial case reporting yoga for idiopathic and degenerative scoliosis. Glob Adv Health Med. 2014 Sep;3(5):16-21. doi: 10.7453/gahmj.2013.064.

Results Reference

result

PubMed Identifier

33717658

Citation

Fishman LM. Isometric Yoga-Like Maneuvers Improve Adolescent Idiopathic Scoliosis-A Nonrandomized Control Trial. Glob Adv Health Med. 2021 Feb 24;10:2164956120988259. doi: 10.1177/2164956120988259. eCollection 2021.

Results Reference

result

Citation

Fishman LM, Groessl EJ, Bernstein P.Two Isometric Yoga Poses Reduce the Curves in Degenerative and Adolescent Idiopathic Scoliosis. Topics in Geriatric Rehabilitation. 33(4):231-237, October/December, 2017.

Results Reference

result

Links:

URL

https://journals.lww.com/topicsingeriatricrehabilitation/Abstract/2017/10000/Two_Isometric_Yoga_Poses_Reduce_the_Curves_in.3.aspx

Description

Adult Scoliosis and Yoga Study

Learn more about this trial

Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis

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