A Phase 2 interventional study of Botulinum toxin type A and Isometric Yoga-like exercise in Scoliosis Idiopathic, Scoliosis; Adolescence and Scoliosis; Lumbar Region, sponsored by Manhattan Physical Medicine and Rehabilitation, LLP. Status unknown at 1 site in United States. Open to participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by Manhattan Physical Medicine and Rehabilitation, LLP · Phase 2, Interventional, and Treatment
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.
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.
603 studies on the registry are indexed under Scoliosis; 141 are open to participants now.
This study's planned enrollment of 42 is close to the median of 44 across 350 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →Manhattan Physical Medicine and Rehabilitation, LLP is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Group I: no isometric yoga-like exercise, no injection given.
Behavioral: Placebo
Group II isometric yoga-like exercise, injection of preservative-free normal saline.
Behavioral: Isometric Yoga-like exercise
Group III: Isometric yoga-like exercise, botulinum injection given
Drug: Botulinum toxin type A · Behavioral: Isometric Yoga-like exercise
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.
Drug: Botulinum toxin type A · Behavioral: Isometric Yoga-like exercise
A position similar to the side-plank (Vasisthasana) held for maximal time at least once daily (usual duration: 30 - 90 seconds).
Also known as: Incobotulinumtoxin A
Extended torso and legs held diagonally by one straight arm, back against wall if necessary
Also known as: Side-Plank, Vasisthasana
Used as placebo
Also known as: no active intervention by drug or yoga-like exercise
Reduction in lumbar and thoracic scoliotic curve
Measured by the Cobb angle in coronal X-rays
Time frame: At study onset
Reduction in lumbar and thoracic scoliotic curve
Measured by the Cobb angle in coronal X-rays
Time frame: 3 weeks after study onset
Reduction in lumbar and thoracic scoliotic curve
Measured by the Cobb angle in coronal X-rays
Time frame: 3 months after study onset
Reduction in lumbar and thoracic scoliotic curve
Measured by the Cobb angle in coronal X-rays
Time frame: 3 weeks after crossover group injections
Reduction in lumbar and thoracic scoliotic curve
Measured by the Cobb angle in coronal X-rays
Time frame: 3 months after crossover group injections
Plan to share: No
This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Botulinum toxin type A
Manhattan Physical Medicine and Rehabilitation, LLP