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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I: Placebo isometric measure, no injection | Sham Comparator | Group I: no isometric yoga-like exercise, no injection given. |
|
| Group II Isometric yoga-like exercise, placebo injection given | Placebo Comparator | Group II isometric yoga-like exercise, injection of preservative-free normal saline. |
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| Group III: True isometric exercise, botulinum injection | Active Comparator | Group III: Isometric yoga-like exercise, botulinum injection given |
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| Crossover | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Drug | A position similar to the side-plank (Vasisthasana) held for maximal time at least once daily (usual duration: 30 - 90 seconds). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in lumbar and thoracic scoliotic curve | Measured by the Cobb angle in coronal X-rays | At study onset |
| Reduction in lumbar and thoracic scoliotic curve | Measured by the Cobb angle in coronal X-rays | 3 weeks after study onset |
| Reduction in lumbar and thoracic scoliotic curve | Measured by the Cobb angle in coronal X-rays | 3 months after study onset |
| Reduction in lumbar and thoracic scoliotic curve | Measured by the Cobb angle in coronal X-rays | 3 weeks after crossover group injections |
| 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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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Loren M Fishman, MD | Contact | 646-642-0700 | lorenmartinfishman@gmail.com | |
| Cara M Cipriano, BA | Contact | (2120 472-0077 | Cara@sciatica.org |
| Name | Affiliation | Role |
|---|---|---|
| Loren M Fishman | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhattan Physical Medicine and Rehabilitation, PLLC | Recruiting | Manhattan | New York | 10022 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25568820 | Result | 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. | |
| 33717658 | Result | 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. |
| Label | URL |
|---|---|
| Adult Scoliosis and Yoga Study | View source |
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Three groups: Group I: Placebo isometric measure, no injection Group II True isometric exercise, placebo injection Group III: True isometric exercise, botulinum injection
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Participants will understand they may receive placebo, and that they will not be told Investigators will know whether they give injections or not, but will not know if injection is placebo.
Outcomes assessors will be blinded to the entire procedure (radiologists reading X-rays).
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| Isometric Yoga-like exercise | Behavioral | Extended torso and legs held diagonally by one straight arm, back against wall if necessary |
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| Placebo | Behavioral | Used as placebo |
|
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| Result | 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. |
| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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