Scoliosis IdiopathicPhase 2NCT04922983
Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis
A Phase 2 study testing Botulinum toxin type A and Isometric Yoga-like exercise in people with Scoliosis Idiopathic and Scoliosis; Adolescence, run by Manhattan Physical Medicine and Rehabilitation, LLP at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis; Lumbar Region
- What is being tested?
- Botulinum toxin type A and Isometric Yoga-like exercise
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Neurological, muscular or neuromuscular disease, (e.gs., cerebral palsy, myopathy, stroke),
- Genetic abnormalities that affect limb growth, proportionality or metabolism, (e.gs., mucopolysaccharidoses, Marfan's syndrome, Refsums disease).
- Pregnancy and other conditions prohibiting X-rays or minute(s)-long exertion (e.gs., congestive heart failure, great weakness, COPD).
- Previous exposure to botulinum neurotoxin Type A. Sexually active female subjects must present a recent negative pregnancy test.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Manhattan Physical Medicine and Rehabilitation, PLLC
Manhattan, New York, 10022
Cara Cipriano, BA, MA, 212-472-0077, carampmr@gmail.com
Loren Fishman, MD, 646-642-0700, loren@sciatica.org
About this study
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.
Read the 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.
- Being tested
- Botulinum toxin type A, Isometric Yoga-like exercise, Placebo
- Keywords
- Adolescent idiopathic scoliosis, scoliosis, yoga, isometric, botulinum
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Incobotulinumtoxin A
A position similar to the side-plank (Vasisthasana) held for maximal time at least once daily (usual duration: 30 - 90 seconds).
Isometric Yoga-like exerciseBehavioural
Also called Side-Plank, Vasisthasana
Extended torso and legs held diagonally by one straight arm, back against wall if necessary
PlaceboBehavioural
Also called no active intervention by drug or yoga-like exercise
Used as placebo
| Study group | Role | What they receive |
|---|---|---|
| Group I: Placebo isometric measure, no injection | Sham comparator | Group I: no isometric yoga-like exercise, no injection given. Receives: Behavioral: Placebo |
| Group II Isometric yoga-like exercise, placebo injection given | Placebo comparator | Group II isometric yoga-like exercise, injection of preservative-free normal saline. Receives: Behavioral: Isometric Yoga-like exercise |
| Group III: True isometric exercise, botulinum injection | Active comparator | Group III: Isometric yoga-like exercise, botulinum injection given Receives: Drug: Botulinum toxin type A; Behavioral: Isometric Yoga-like exercise |
| 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. Receives: Drug: Botulinum toxin type A; Behavioral: Isometric Yoga-like exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in lumbar and thoracic scoliotic curve
Measured by the Cobb angle in coronal X-rays
Measured: At study onset
Reduction in lumbar and thoracic scoliotic curve
Measured by the Cobb angle in coronal X-rays
Measured: 3 weeks after study onset
Reduction in lumbar and thoracic scoliotic curve
Measured by the Cobb angle in coronal X-rays
Measured: 3 months after study onset
Reduction in lumbar and thoracic scoliotic curve
Measured by the Cobb angle in coronal X-rays
Measured: 3 weeks after crossover group injections
Reduction in lumbar and thoracic scoliotic curve
Measured by the Cobb angle in coronal X-rays
Measured: 3 months after crossover group injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Jul 2021
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manhattan Physical Medicine and Rehabilitation, LLP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loren M Fishman, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922983
- Sponsor's protocol ID
- Pro00047989
- Status last verified
- Aug 2023
- First submitted
- 3 Apr 2021
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25568820Fishman 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.
PubMed 33717658Fishman 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis
- ClinicalTrials.gov ID
- NCT04922983
- Acronym / sponsor ID
- Pro00047989
- Keywords
- Adolescent idiopathic scoliosis, scoliosis, yoga, isometric, botulinum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Manhattan Physical Medicine and Rehabilitation, LLPUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Group I: Placebo isometric measure, no injection | Sham comparator | Behavioral: PlaceboGroup I: no isometric yoga-like exercise, no injection given. |
| Group II Isometric yoga-like exercise, placebo injection given | Placebo comparator | Behavioral: Isometric Yoga-like exerciseGroup II isometric yoga-like exercise, injection of preservative-free normal saline. |
| Group III: True isometric exercise, botulinum injection | Active comparator | Drug: Botulinum toxin type A, Behavioral: Isometric Yoga-like exerciseGroup III: Isometric yoga-like exercise, botulinum injection given |
| Crossover | Active comparator | Drug: Botulinum toxin type A, Behavioral: Isometric Yoga-like exerciseAfter 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AAlso: Incobotulinumtoxin AA position similar to the side-plank (Vasisthasana) held for maximal time at least once daily (usual duration: 30 - 90 seconds). | Drug | Crossover, Group III: True isometric exercise, botulinum injection |
| Isometric Yoga-like exerciseAlso: Side-Plank, VasisthasanaExtended torso and legs held diagonally by one straight arm, back against wall if necessary | Behavioural | Crossover, Group II Isometric yoga-like exercise, placebo injection given, Group III: True isometric exercise, botulinum injection |
| PlaceboAlso: no active intervention by drug or yoga-like exerciseUsed as placebo | Behavioural | Group I: Placebo isometric measure, no injection |
Primary outcome
Reduction in lumbar and thoracic scoliotic curve
Time frame: At study onset
Measured by the Cobb angle in coronal X-rays
Reduction in lumbar and thoracic scoliotic curve
Time frame: 3 weeks after study onset
Measured by the Cobb angle in coronal X-rays
Reduction in lumbar and thoracic scoliotic curve
Time frame: 3 months after study onset
Measured by the Cobb angle in coronal X-rays
Reduction in lumbar and thoracic scoliotic curve
Time frame: 3 weeks after crossover group injections
Measured by the Cobb angle in coronal X-rays
Reduction in lumbar and thoracic scoliotic curve
Time frame: 3 months after crossover group injections
Measured by the Cobb angle in coronal X-rays
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Results publication: PubMed 25568820Fishman 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.
- Results publication: PubMed 33717658Fishman 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.
- Results publicationFishman 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.
- Adult Scoliosis and Yoga StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loren M Fishman principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum toxin type A and Isometric Yoga-like exercise in people with Scoliosis Idiopathic and Scoliosis; Adolescence, run by Manhattan Physical Medicine and Rehabilitation, LLP at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Loren M Fishman, MD (646-642-0700, lorenmartinfishman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in lumbar and thoracic scoliotic curve (time frame: At study onset). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04922983, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.