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

Scoliosis Idiopathic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04922983
• Other study ID #: Pro00047989
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic
• Scoliosis; Adolescence

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

External Links

•   Adult Scoliosis and Yoga Study