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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	14 Years - 18 Years
Gender	All

More Inclusion & Exclusion 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:
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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04922983
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Manhattan Physical Medicine and Rehabilitation, LLP
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Loren M Fishman
Principal Investigator Affiliation	Columbia University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis; Lumbar Region
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Sham Comparator: Group I: Placebo isometric measure, no injection

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

Placebo Comparator: Group II Isometric yoga-like exercise, placebo injection given

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

Active Comparator: Group III: True isometric exercise, botulinum injection

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

Active Comparator: Crossover

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.

Interventions

Drug: - Botulinum toxin type A

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

Behavioral: - Isometric Yoga-like exercise

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

Behavioral: - Placebo

Used as placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Manhattan, New York

Status

Recruiting

Address

Manhattan Physical Medicine and Rehabilitation, PLLC

Manhattan, New York, 10022

Site Contact

Cara Cipriano, BA, MA

[email protected]

212-472-0077

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