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

Manhattan Physical Medicine and Rehabilitation, LLP

Status and phase: Enrolling; Phase 2

Conditions: Scoliosis; Lumbar Region; Scoliosis; Adolescence; Scoliosis Idiopathic

Treatments: Behavioral: Placebo; Behavioral: Isometric Yoga-like exercise; Drug: Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT04922983

Pro00047989

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 14 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

42 participants in 4 patient groups, including a placebo group

Group I: Placebo isometric measure, no injection

Sham Comparator group

Description:

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

Treatment:

Behavioral: Placebo

Group II Isometric yoga-like exercise, placebo injection given

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Isometric Yoga-like exercise

Group III: True isometric exercise, botulinum injection

Active Comparator group

Description:

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

Treatment:

Drug: Botulinum toxin type A

Behavioral: Isometric Yoga-like exercise

Crossover

Active Comparator group

Description:

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.

Treatment:

Drug: Botulinum toxin type A

Behavioral: Isometric Yoga-like exercise