Clinical trial NCT04922983: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Scoliosis Idiopathic
Scoliosis; Adolescence
Scoliosis; Lumbar Region
Keywords: Adolescent idiopathic scoliosis
scoliosis
yoga
isometric
botulinum
Lead sponsor: Manhattan Physical Medicine and Rehabilitation, LLP
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 42
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: TREATMENT

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.

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:

  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.

Primary outcomes:
measure: Reduction in lumbar and thoracic scoliotic curve
timeFrame: At study onset
measure: Reduction in lumbar and thoracic scoliotic curve
timeFrame: 3 weeks after study onset
measure: Reduction in lumbar and thoracic scoliotic curve
timeFrame: 3 months after study onset
measure: Reduction in lumbar and thoracic scoliotic curve
timeFrame: 3 weeks after crossover group injections
measure: Reduction in lumbar and thoracic scoliotic curve
timeFrame: 3 months after crossover group injections
Secondary outcomes:
Other outcomes:
Locations:
city: Manhattan
country: United States
facility: Manhattan Physical Medicine and Rehabilitation, PLLC
state: New York
Study officials:
affiliation: Columbia University
name: Loren M Fishman
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.