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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04922983
Other study ID # Pro00047989
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 1, 2021
Est. completion date January 1, 2026

Study information

Verified date August 2023
Source Manhattan Physical Medicine and Rehabilitation, LLP
Contact Loren M Fishman, MD
Phone 646-642-0700
Email lorenmartinfishman@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date January 1, 2026
Est. primary completion date July 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 18 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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
Placebo
Used as placebo

Locations

Country Name City State
United States Manhattan Physical Medicine and Rehabilitation, PLLC Manhattan New York

Sponsors (1)

Lead Sponsor Collaborator
Manhattan Physical Medicine and Rehabilitation, LLP

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in lumbar and thoracic scoliotic curve Measured by the Cobb angle in coronal X-rays At study onset
Primary Reduction in lumbar and thoracic scoliotic curve Measured by the Cobb angle in coronal X-rays 3 weeks after study onset
Primary Reduction in lumbar and thoracic scoliotic curve Measured by the Cobb angle in coronal X-rays 3 months after study onset
Primary Reduction in lumbar and thoracic scoliotic curve Measured by the Cobb angle in coronal X-rays 3 weeks after crossover group injections
Primary Reduction in lumbar and thoracic scoliotic curve Measured by the Cobb angle in coronal X-rays 3 months after crossover group injections
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