Research

YOGA AND MUSCLE INJECTIONS

FOR

ADOLESCENT SCOLIOSIS

A RANDOMIZED CONTROLLED  FREE TRIAL IN WHICH EVERYONE GETS THE FULL TREATMENT

SINGLE VISIT

We have been given a grant to study the effects of combining yoga and botulinum toxin on adolescent idiopathic scoliosis (AIS).  The study is for young people 14 – 18 years of age and requires only one visit to our offices in Manhattan.

The study adds to the already proven value of yoga in reversing the curves of scoliosis by using botulinum toxin, familiar to most people as “Botox,” made by the Allergan Corporation, although the medication is actually made by several different manufacturers in the United States and Europe.

The most recent peer-reviewed study demonstrates the efficacy of practicing one yoga pose for at most a few minutes daily in reversing lumbar curves in adolescents. It is backed up by two other, earlier peer-reviewed different-authored studies that come to the same conclusion.  Essentially, yoga strengthens the muscles of the weaker side, the convex side of the lumbar curve, and when the muscles are more or less equal in strength to the muscles on the concave side, the curve is substantially diminished.  In this study, we also use botulinum toxin to partially and temporarily weaken the stronger side, enabling the weaker side to gain traction and overcome the asymmetrical pull of the strong side.

At this writing (May 4th, 2022) we have followed 9 patients each of whom has improved 8 – 16 degrees in  secondary X-rays 3 weeks after being taught the yoga pose and receiving the botulinum.  In the history of treating scoliosis conservatively, this is noteworthy, even remarkable.  Most conservative methods are intended only to stop progression of scoliosis, not to reverse it, and even the successful yoga treatments by themselves would give just 25% as much correction in that time frame. Only surgery, which is not done unless the curves exceed 45 degrees, gives results like this.

The study protocol has been reviewed and approved by the FDA and the IRB (Institutional Review Board) relevant to this subject matter.  These boards approve prospective studies only if they are deemed safe and scientifically cogent, with a reasonable likelihood of success.  But the question arises:  if the study is randomized and with controls, how can everyone be guaranteed to receive the proper yoga pose and the actual botulinum toxin?

The answer is that this is a crossover study, so the control group receives the actual medicine three months after study onset. The study has three groups:

Group I: Placebo yoga pose and no injection

Group II The correct yoga pose and sham injection.

Group III: The correct yoga pose and botulinum injection.

We recommend EOS X-rays, which have only 1/9 the regular X-rays’ radiation (already extremely low) which are done at 3 weeks and 3 months after the visit to our office.

At that time patients may return to  our office, and those in Groups I and II will receive the botulinum injections, and those in Group I will be taught the proper yoga pose.

At that point Group III is done with the study; Groups I and II continue on for another 3 months.

They will have repeat (free) X-rays at 3 weeks and 3 months either in Manhattan or near their homes.

Subsequent treatment and/or injection is determined by consultation between the physician and patient and family.

To register for the study at our office in Manhattan, click here. For more information, please call (212) 472-0077 and speak with Cara Cipriano or Danielle Coombs, or write carampmr@gmail.com or Danielle Coombs at Danielle@sciatica.org.


Dr. Fishman is a physician with advanced Board in Rehabilitation Medicine, currently on the staff at Columbia University Medical School.  He has over 100 publications including 12 books and many peer-reviewed research articles. He is past President of the New York Society of PMR and  and has a graduate degree in Philosophy from Oxford University in England.  He has also spent nearly one year with B.K.S. Iyengar in India. For more on Dr. Fishman, click here.

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All donated funds are used for research.

Manhattan Physical Medicine and Rehabilitation

133 East 58th Street (Between Park and Lexington)

(212) 472-0077

Clinical Research Studies & New Resource

Osteoporosis: the Dose-Response Study

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Yoga vs. Osteoporosis: the Dose-Response study

In spite of positive comments about the study in the New York Times, the Harvard Women’s Health Letter and NPR, the almost free and effective treatment has not gained much application in the medical community. But we believe it should.  The current treatment for osteoporosis: medications have a deservedly bad reputation because of their many side-effects. Dr. Ethel Siris, a prominent authority in the field of osteoporosis studied more than 100,000 osteoporotic women who had health insurance covering the cost of osteoporosis medications. She found that less than 30% actually took these medicines, at least partially because of their common and severe side-effects. But the side-effects of yoga are better posture, improved balance, greater strength, range of motion and coordination, and lower anxiety, all factors that mitigate the risk of fractures just about as strongly as the rise in bone mineral density. Therefore we are beginning a new study, seeking a dose-response relationship between yoga and bone mineral density and bone quality, a more compendious measure of a bone’s resistance to fracture.

For those interested in the new study, beginning summer-fall 2016 and ongoing until further notice, the following is relevant.

This study attempts to prove that properly chosen yoga poses can reverse osteoporosis without having negative effects on the joints. In addition, we hope to establish a dose-response relationship between the quantity and quality of yoga, and rise in bone mineral density, and possibly bone quality.

Conventional medical wisdom puts people in an impossible position: exercise with impact, jogging, for example, is needed to stimulate the cells that build bone, but unfortunately, such exercise fairly reliably brings about arthritic joint destruction. No-impact exercise is harmless to the joints, but unfortunately, leaves the bones to slowly weaken even to the breaking point.

Therefore when it comes to bones, it is literally both ends against the middle. At the same time, it is universally acknowledged that not exercising at all tightens joints and ligaments, weakens muscles and bones alike, and is the worst of both worlds.

As the population of the world grows older, these questions are critical for the continued activity and health of an increasing number of people. Present estimates are that 200,000,000 people suffer from osteoporosis or osteopenia.

Evidence in the animal literature confirms that unconventional tugs of the sinews and ligaments can arrest, and often reverse osteoporosis. The pilot study detailed below corroborates these findings. The transcriptional coactivator PGC-1alpha is liberated from muscles in exercises such as yoga, and suppresses a broad array of inflammatory responses, likely including arthritis.1 There are also physiological reasons to believe that yoga improves the circulation of synovial fluid, within joints, slowing the “wear and tear” that may stand at the origins of osteoarthritis.

The proposed study measures osteoporosis through the accepted means, radiographic bone density measurement, dual energy X-ray absorptiometry otherwise known as DEXA scans. We measure progression in osteoarthritis with standard hip and lumbar spine X-rays. Each subject has thyroid functions, standard electrolyte, mineral and liver/kidney function tests, two assays for vitamin D, and a urine test measuring the rate of bone resorption before learning the 12 yoga poses that comprise the program. Bone scans and X-rays, performed at study onset and at the end of year 2, are read by radiologists that have no idea which patients are receiving yoga, and which are not.  A DVD of the poses is for sale on the Store page of this site, and its full contents are also available to stream without cost at:

https://www.youtube.com/watch?v=o8SjystaH-E.

A scientific paper will be written if and when results are judged significant.

In order to do a meaningful analysis of the “dose” of yoga, it will be necessary for participants to study with a yoga teacher who has more than five years teaching experience and who is certified in Dr. Fishman’s Yoga vs. Osteoporosis method every two weeks. Your arrangement with the teacher is up to you and the teacher. It may be a group class or an individual session or a short review. There are currently 500 certified teachers in 48 states and twelve countries. For a state-by-state list, click Teachers’ tab above.  If you are not located near a certified teacher, you can also study online with any certified teacher willing to do so. Dr. Fishman teaches a weekly class on Tuesdays 5:30 – 6:30 PM  (ET).

If you would like to become a certified teacher of Dr. Fishman’s Method of Yoga vs. Osteoporosis, please note that we generally offer this certification course several times a year. The best way to find out about upcoming teacher trainings is by signing up for the newsletter using the fields below.

We have already completed a ten-year study of yoga vs. osteoporosis.  The results of this study were published by the peer-reviewed journal Topics in Geriatric Rehabilitation. In this study, we analyzed the outcome of 741 people who completed at least two years of yoga (the intervention group), and their change in bone mineral density during the two year period after they began doing the poses on the Series 1 DVD. These people had an average age of over 68 years, and all had normal laboratory values. Over 80% had osteoporosis or osteopenia at the study’s onset.

The patients that did yoga for two years now have stronger bones than they did when they started. Statistically, this result was significant.

Sometimes we have had to adapt the yoga poses for people that are unable to use the classical position. The DVD has three versions of each pose, and your teacher will very likely be able to help you with that.The idea is to progress from the simplest level to the more advanced levels in any pose for which it is safe to do so. Trying hard, putting some effort into the 12 minutes of yoga, is also important. The Iyengar yoga method that stands behind each of the poses pays great attention to alignment, enabling people to try hard without injury.

There were no injuries reported as a result of doing the yoga in the ten years of the study. With 741 people in the study, (227 fully documented) and well beyond 100,000 hours of people doing these poses, many of them having before-and-after X-rays of spine and hips, we had no reported fractures related to yoga. Interestingly, we have over 20 fractures reported from falls on the street, traffic accidents, and the like.

The results of the study are now in, and the statistician has found that yoga does significantly improve bone mineral density for the spine, (P <.05) the femur (P < .002) and, slightly less convincingly, for the hip (P < .05 on 2 of 3 measures; not significant for the third). This work appeared in the peer-reviewed journal “Topics in Geriatric Rehabilitation.”

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4851231/

If desired, the First Series DVD may be purchased by anyone for $25 on the home page of this website, and its full contents are available for free at YouTube. The Second Series DVD series can also be purchased at the Store page of this website.  Participants who are accepted to the Dose-Response Study receive copies of both DVDs free of charge.

To join the Dose-Response Study (Dose of yoga – Response in bone mineral density), candidates must:

  1. Submit a current DEXA scan (less than 6 months from date of study entry).  Results must be shown in g/cm. T-scores alone are not sufficient.
  2. Submit one or more past DEXA scans, at least one year previous to study entry. Results must be shown in g/cm. T-scores alone are not sufficient.
  3. Complete the Application Form available at the website “sciatica.org” under the tab “Osteoporosis.”
  4. If the candidate’s most recent DEXA scan shows osteopenia or osteoporosis, then he or she must complete six blood tests and one urine test:
    1. Blood Tests:
      1. TSH (thyroid stimulating hormone
      2. PTH (parathyroid hormone)
      3. Vitamin D,25 – hydroxyl
      4. Vitamin D, 1,25 dihydroxyl
      5. CMP (Complete Metabolic Profile
      6. ESR Erythrocyte Sedimentation rate) or CRP (C-reactive protein
    2. Urine Test:
      1. NTX (a measure of collagen bonds to determine bone resorption rate)

This is a clinical study, so it is critical that relevant (bone building or resorbing) medicines remain unchanged during the entire study period. This period begins when you had the first DEXA scan one or more years ago, and will extend until you have your first DEXA following two years practicing the yoga.  If you have begun or discontinued any relevant medicine after the DEXA scan you submitted to us from one or more years ago, unfortunately you cannot be in the study.If you have been taking a medicine that either improves or resorbs bone from before the time you had the first DEXA a year or more ago, and are committed to continue taking it at least until the third DEXA scan is done, that is acceptable.  So long as these medicines are consistently held at a given level (or not at all), you are eligible for the study.  However, if you need to change one of these bone-active medicines during the study period, you must let us know. 

Medications reported to build bone:  Bisphosphonates:Fosamax (alendronate), Binosto (alendronate), Boniva (ibandronate), Reclast (zoledronic acid), Zometa (zoledronic acid), Aclasta (zoledronic acid), Prolia (denosumab), Evista (raloxifine), Atelvia (raloxifine), Forteo (teriparatide), Evenity (romosozumab). 

Supplement: Strontium

Medications reported to promote significant bone loss:Steroids taken orally or injected such as cortisone and triamcinolone, chemotherapeutic agents, and aromatase inhibitors.

Summary:  All you need to do is keep taking all the relevant medications (or not taking them) from the first DEXA you submitted to the study until you’ve submitted your third DEXA at the conclusion of your 24-month participation in the study.

  1. If the candidate’s most recent DEXA scan does not show osteoporosis or osteopenia, he or she does not need to have these blood tests and urine tests.
  2. Recommended but not required:  If you are under 75 years of age, take 1500 mg Calcium, 1500 IU of Vitamin D3, and 250 mg of Magnesium, preferably as a chelate with amino acids.  Those over 75 should take 500 mg of Calcium.
  3. Have a live session (either in-person or online) with a Certified Teacher** every 2 weeks for the 2-year study period.  Attending Dr. Fishman’s online Zoom class on Tuesdays at 5:30 PM ET may be used to fulfill this requirement.  Attendance at this class must be live in order to receive feedback on poses. Attendance solely via recording is not permitted.
  4. Complete another DEXA scan two years after entering the study, preferably at the same facility, and provide the results to us.
  5. Optional: hip and spine X-rays at study onset and after 2 years.

*Candidates whose DEXA scans do not reveal osteopenia or osteoporosis do not need to take these tests.

**Certified teachers’ names and emails are listed by state in the Teachers tab above.

We request that all study participants inform us of any major medical, dietary and/or major activity changes that occur during the course of the study.

Questions may be addressed to Dr. Fishman at Loren@sciatica.org. To save time and trouble, see the FAQ section below first.

FAQ

  1. When does the study start and end?

The study has begun and we are taking rolling admission of qualified applicants until further notice.

  1. What is required of me to be in the study?

Two DEXA scans one of which  is from at least one year ago, the other within 6 months of entering the study.

If the current DEXA scan shows you have osteopenia or osteoporosis, then you must complete the blood tests and urine test described above. If you do not have osteopenia or osteoporosis the you do not need to submit any blood or urine tests.

Completed Application Form

Arrange to meet with certified teacher bi-monthly, OR opt to participate in Dr. Fishman’s online Zoom class on Tuesdays at 5:30 PM ET. Please note that as of June 1, 2022, we are very close to capacity for Dr. Fishman’s class: there are only eight places left in his class.

Track progress weekly using the online form which we will provide to you after you are accepted into the study.  Please note that data must be entered on a weekly basis using our form.  Other forms of record-keeping are not acceptable.  You must use the form that we provide to you.  If data is not entered on a regular and consistent basis, then participants may be deemed inactive and removed from the study, and from Dr. Fishman’s weekly classes.

3. Do I need to work with a certified teacher 30 min bi-weekly or 60 min? What is the cost?

In order to participate in the study, you study with a teacher who is certified in Dr. Fishman’s Method of Yoga vs. Osteoporosis, and who has been teaching for more than five years, for either 30 minutes or 60 minutes two times per month. You are required to meet with them bi-monthly in person or live online, OR you can opt to take Dr. Fishman’s online class via Zoom on Tuesday evenings at 5:30 PM. Costs vary per teacher. Please contact the teacher directly to learn about rates. Some teachers are developing Yoga for Osteoporosis classes, which are likely to be lower cost.  Dr. Fishman’s Tuesday class on Zoom at 5:30 PM fulfills this requirement and is free to study participants in good standing (i.e. entering their data weekly on a consistent basis. using our form). Please note that as of June 1, 2022, we are very close to capacity for Dr. Fishman’s class: there are only eight places left in his class.

  1. When does the study officially begin for me? Does it start after my first session with the certified teacher?

Yes.

  1. What is the new study?

The new study measures the participants’ involvement closely, and compares the versions of the poses they use, their frequency, and the intensity with which they are performed.

  1. Why do another study about yoga and osteoporosis?

The first 741 patient study had 241 patients who submitted all the data we requested. The study showed that yoga significantly improved bone mineral density in the spine and the hip bone and caused no known fractures or serious injuries of any kind in over 100,000 hours of people, 83% of whom had osteoporosis or osteopenia. But it did not change most physicians’ minds; the vast majority still prescribe the medicines, and regard yoga as just recreation and “dangerous” for people with weakened bones. This second study matches the amount, quality and intensity of the yoga with the resultant changes in bone mineral density. This is one of the ways pharmaceutical firms establish and illustrate the beneficial effects of medications. The second study attempts to match the model that is quite familiar to physicians and health-care executives in an effort to persuade them at least to try yoga to reverse osteoporosis.

  1. If I have osteoporosis, is it dangerous for me to do the Intermediate (formerly known as Osteopenia version) or Classical (formerly known as Preventive) version of the postures?

Absolutely not. We ask everybody to start with the beginner (formerly known as Osteoporosis version) poses for a week, but then encourage each person to advance as quickly as he or she safely can. That means in some poses an individual with osteoporosis may be doing the intermediate version, and before long may progress to the Classical version of some of the poses. The key to doing safe, vigorous poses is good alignment. That is the purpose of the visits to the Certified Teacher.

  1. Do I have to advance from all Beginner poses to all Intermediate poses and then to all Classical/Advanced poses?

Definitely not. You may find that you are at different levels for the various poses.  Some will be more challenging than others; this is normal. So you may be doing a mix of beginner, intermediate and classical variations of the poses during the course of the study.

  1. Are the Classical/Advanced poses more powerful bone builders than the Intermediate poses, and are the Intermediate poses better bone builders than the Beginner poses?

We’re not sure, but we think so. But each pose at each level will benefit those people more who practice it more vigorously. Still, in every case, safety first.

  1. What if I am sick for a week and cannot do the poses. Am I out of the study?

By no means. This is a dose-response study. A lower “dose” of yoga may affect your second DEXA scan a little. There are 104 weeks in your participation. One week is less than 1%.  Continue to enter your data on our form, indicating that you did not practice.

  1. How does the study record participants’ yoga?

You will record your own consistency, and which versions of the poses you are performing using an online form that we provide to you. For example, you might indicate that you did the intermediate version of the twisted triangle 5 times last week. When you are admitted to the study, you will receive a unique identifying participant number. In order to comply with HIPAA rules, you must use the number when you input your yoga involvement each week. If unfeasible, you can report your yoga activity on a two-week basis, but if you let it go longer than that, the data becomes unreliable.

  1. What stops people from “cheating” by working harder when they see the teacher than when they are at home, or saying they did the poses more often (or less often) than they really did?

We expect people to tell the truth. If they do not, to please us or their teachers, or for whatever reason, it will impair or ruin the entire effort.

16. Do I need both DEXA scans and labs to join the study?

Yes, you need a DEXA scan from at least a year ago, and another within 6 months of your entry to the study. It is best to have it close to study entry, so the results can determine whether or not you need the blood and urine tests. If your DEXA does not reveal either osteopenia or osteoporosis, you do not need the blood or urine tests. If you have either osteopenia or osteoporosis, you need the blood and urine tests. If any of the tests are abnormal, then you must see the appropriate specialist and correct the value(s) before being accepted into the study. At the end of your 24 months of participation in the study, you will need to have another DEXA scan, and provide us with the results.

Reference (Click on name to go to reference)

1. Handschin C, Spiegelman BM. “The role of exercise and PGC1alpha in inflammation and chronic disease.”Nature. 2008 Jul 24;454(7203):463-9.

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A New Resource: YIP.guru (Yoga Injury Prevention)

What are the major causes of yoga injuries, in which poses, and what are the major injuries?

A 33,000 yoga teacher and student study.

https://sciatica.org/?page_id=769&preview=true

On the basis of this, and 40+ years devoted to medicine, teaching yoga, and using yoga for medicinal goals, we have constructed a website, YIP.guru (Yoga Injury Prevention),  which physicians, therapists, teachers and practitioners of yoga can use to see which poses are contraindicated by common medical and orthopedic conditions, and also which poses will benefit people with a large variety of medical and orthopedic issues, including pregnancy. Click here

YIP.guru (Yoga Injury Prevention)

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Piriformis Syndrome

We have recently completed a double blinded randomized controlled study comparing botulinum injection to placebo in people for whom the electromyographic evidence favored piriformis syndrome.

The entire study is being reviewed now for publication (August 27, 2016), but the graphic representations of the results are so good that I cannot resist putting them here.

https://sciatica.org/?page_id=775

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Rotator Cuff Syndrome

We stumbled upon a series of maneuvers which activates muscles that perform the actions of the torn supraspinatus muscle. Then a process akin to operant conditioning prompts the same muscles to be active whenever the torn muscle would be brought into play, perpetuating the substitution so that people may painlessly and powerfully lift the arm in ways that previously were prevented by the torn muscle.

https://sciatica.org/?page_id=795

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Yoga Poses to Reverse Scoliosis

We have found a simple yoga pose which, done one time daily, reverses nearly every case of scoliosis we have encountered. We published a small series of adolescent idiopathic scoliosis patients’ and degenerative scoliosis patients’ successes with this simple method, and are currently studying more advanced methods with more complex curves.

https://sciatica.org/?page_id=786

Emboldened by this early success, we did a larger study, published in November 2017:

https://journals.lww.com/topicsingeriatricrehabilitation/Fulltext/2017/10000/Two_Isometric_Yoga_Poses_Reduce_the_Curves_in.3.aspx 

And a third article in 2021:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4268609/

Surprising to some, the method works almost as well for adults with degenerative scoliosis as it does for adolescent idiopathic scoliosis. Once again, although mentioned and appreciated in main-stream news media such as the Wall Street Journal, the pediatricians, family practitioners and orthopedic surgeons of this world have taken little note of what we have shown can be done.

Therefore we are continuing to study the patients we are honored to treat with this non-invasive do-it-yourself-at-home method that takes minutes a day and works for almost everyone. Those interested should just make an appointment at our office: (212)-472-0077. For people too far away, we have actually taught the method with equal success through Skype and Zoom.

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