Yoga for Juvenile Idiopathic Scoliosis

The side plank for treatment of idiopathic lumbar and thoracolumbar scoliosis in 8 - 12-year-olds: a randomized, controlled, blinded crossover study.

Prospective subjects and their families will be initially screened via telephone or other media to establish that subjects meet the criteria of the study:

Inclusion criteria:

1. 8-12 years of age.
2. Lumbar or thoracolumbar idiopathic scoliotic curve equal to or greater than 10 degrees, less than or equal to 45 degrees.
3. Stated willingness to do the yoga or yoga-like poses three times daily.
4. Verbal consent, validated assent by patient and written consent of parent/guardian.
5. Pre-test Cobb films 1) within 3 months prior to teaching, or within 72 hours afterwards." .

Exclusionary criteria:

1. Neurological, muscular or neuromuscular disease, (e.g.s., cerebral palsy, myopathy, osteogenesis imperfecta).
2. Genetic abnormalities that affect limb growth, proportionality or metabolism, (e.gs., mucopolysaccharidoses, Marfan's syndrome, Refsums phenylketonuria).
3. Previous spinal surgery or other conditions prohibiting X-rays or minute(s)-long exertion (e.gs., congestive heart failure, great weakness, severe COPD).
4. Previous exposure to botulinum neurotoxin Type A.

Sexually active female subjects must present a negative pregnancy test performed within one week of the initial visit. The urine test is preferred, but patients may present HCG or other test results if they desire.

Arrangements will be made to satisfy the criteria of the study, if necessary. E.g., A prescription for scoliosis films will be made out to obtain recent films if none are available. We will prefer EOS films with 1/9 the radiation of the (already low) standard X-rays when they are available.

Visits may be in person or online. Weight and vital signs will be recorded as possible before teaching the yoga pose(s).

After viewing the X-rays and physical examination, each patient will be taught the appropriate pose or placebo. The physical examination will have six parts: Vital signs, range of motion, strength, sensory systems, reflexes and coordination (including balance). These can be readily measured for in-office appointments.

For virtual visits:

Vital signs: we will rely on a pediatrician's record for a recent blood pressure reading and weight, but can do pulse by having the patient or parent call out heart beats while we time them, use a home scale for weight, and we can observe respiratory rate over the Internet. Patients' families can supply basal temperature using a home thermometer.

Range of motion is easily assessed visually.

Strength will be measured in pushups, deep squats and heel and toe walking.

Sensory systems will be measured with a parent, guardian or other reiable person gently prodding the upper and lower extermities for numbness or asymmetries.

Reflexes will be tested by a responsible party striking the Achilles tendons and patellar tendons.

Coordination and balance were already measured in part with heel and toe walking, but will be completed with finger-to-nose and one-legged standing with eyes open and with eyes closed.

The sessions generally last half an hour to one hour and one session is usually enough for parents or guardians and the young participant to learn their procedure. The participant will always have to show competence in performing the poses before the session ends.

Each pose has a strengthening component applied to the convex side and a stretching component applied to the concave side.

Randomization: Two groups in 1:1 ratio will have 14 participants in each group.

Intervention group procedure:

Participants with lumbar or thoracolumbar scoliosis will be shown the yoga pose(s) by a certified (IAYT) yoga therapist and then invited to do the pose with his or her back to a wall. Please see appendix for details of remedial versions for participants unable to perform the pose because of weakness, trepidation or poor coordination.

Lumbar curve:

Side Plank (Vasisthasana)

with convex side downward. The Side Plank involves supporting the practitioner's weight on the palm of the hand on the convex side. It is taught with back to the wall both for safety and to keep the torso at right angles to the floor to maximize the challenge to the convex (weaker) side's quadratus lumborum, psoas, and paraspinal musculature. Participants and their parent(s) or guardians are taught this pose in a single session, with a follow-up zoom or in person session in 3-5 weeks. Participants are to do the pose 3 times daily for as long as they safely hold the pose.

In addition, participants are to precede the three Side Planks with the "Lazy Side Plank," doing the same pose on the opposite side, but bulging the concave side downward as much as possible. This pose should be done for twice as long as the longest version of the Side Plank on the previous day. For example, someone who did the three Side Planks for 45 seconds, 50 seconds and 60 seconds on Monday would start off on Tuesday doing the "Lazy Side Plank" for 120 seconds.

Stretching Pose: "Lazy" Side Plank

Every day participants should do this stretching pose with the other side (the strong, concave side) down:

Let yourself sag down in the low ribs and side of your abdomen. Stretch your spine in the opposite direction of your scoliosis. Let your body bulge down like a hammock.

This pose stretches the concave side. It is done by reversing the regular side plank, this time with the concave side down, making that side sag down as much as you can.

Thoracolumbar curve:

Warrior II (Virabhadrasana II) with belt. This pose starts with concave side's foot parallel to the wall, and the knee bent 90 degrees. The shoulders are directly above the hips, aligned with them right to left and front to back. The arms are collinear, horizontal, and stretched as far apart as possible. This pose can also be done sitting on a chair but advancing to the pose shown here as soon as possible. Once again it should be done three times daily and held as long as possible.

The Latch-Gate pose (Parighasana) is the stretching pose that should precede the Warrior II every day. Pictured here, the right side is the originally concave side. It is being stretched by curving the back toward the convex side, and in the picture, actually reversing the curve and thereby stretching the right, originally concave side. It should be done before doing either the Warrior II or the Half-Moon pose described below. It should be done for twice as long as the longest version of the Side Plank on the previous day.

Half-moon (Ardha Chandrasana) with belt Like the other poses, this pose must be done with a wall behind, both for safety and to raise the upper torso so the shoulders are vertical.

The convex side is down, the supporting leg's foot is parallel to the wall and 2-3 inches from it. Both shoulder blades are flush with the wall. A belt loops around the elevated foot and is held in the upper hand. With

the upper arm perpendicular to the torso, the participant pulls on the belt as strongly as possible.

The stretching pose for the Half-Moon is the Gate-Latch. If a participant is doing both poses, he or she need do the stretching pose only once, at the beginning of each daily session. Its practice follows the same protocol as the "Lazy Side Plank" and Gate-Latch pose above.

Control group procedure:

This a standard yoga pose that is good for many physical, mental and spiritual aspects of a young person's development, but has no effect on scoliosis.

Injections, bracing or medication:

There is no injection, bracing or medication associated with this study.

Instructions to all participants after teaching the pose(s):

"Perform the pose(s) three times daily, holding the position for as long as you can. This can be done serially, e.g., three times right after each other in the morning, or spaced out, e.g., one in the morning, one at noon and one before dinner. If you feel dizzy, or think you're about to faint, come down, of course."

Number of sessions:

The intervention group patients will have in toto two scoliosis films and return for two follow-up visits: X-rays: 1) within 3 months prior to teaching, or within 72 hours afterwards, 2) Four months following teaching. Follow-up visits: 1) two months after teaching and 2) four months after teaching and second X-ray. Follow-up visits can be done as virtual visits. We encourage EOS X-rays, which have only 1/9th the radiation of the already low standard X-rays.

Each control group patient will have in toto three scoliosis films and return for three follow-up visits: X-rays: 1) within 3 months prior to teaching, or within 72 hours afterwards, 2) four months following teaching the placebo protocol, 3) four months after beginning intervention protocol. Follow-up visits: 1) Four months after teaching the control protocol, 3) four months following teaching the intervention protocol.

Patients and their consenting families will be notified of the results of all X-ray studies. EOS X-rays are preferred because of their lower radiation. The patients' families' cost of X-rays done after study's onset will be reimbursed at the study's conclusion at a rate not to exceed $100 per X-ray.

Notes: All instruction will be given by Dr. Fishman or other qualified personnel in our office or over the Internet in webinar format.

Background and Rationale for the Study:

Between 6 - 9 million Americans suffer from scoliosis. Since the advent of the Salk vaccine and good preventative measures for tuberculosis, approximately 90% of the cases of scoliosis are adolescent idiopathic scoliosis - curves of 10 degrees or more without known cause. Currently curves under 25 degrees are observed, those 25-45 degrees are braced, and those beyond 45 degrees are generally considered for surgery. Alternative treatments: physical therapy and the Schroth and Clear methods have conflicting reports of success in the literature, and the Cochrane database give them "very low" evidential ratings.

• Further, the success of bracing is also controversial, and although surgery is generally successful in lessening curves' intensity, Harrington Rods, Cottrell-Dubousset, Scottish Rite and tethering methods leave young patients with greatly lowered ranges of motion, aftereffects such as pseudarthrosis,
• Adjacent Segment Disease, infection, flatback syndrome and hardware complications, and are estimated to require subsequent revision 21-50 % of the time.1,2 The average cost of these surgeries (not including revisions) is $175,000, and often a semester of school.

Our Approach:

The vertebral column can be seen as a tensegrity structure: one held up by tension created by the muscles that attach to it. So regarded scoliosis appears to be due to asymmetry in the force these muscles exert on different regions of the column. We have investigated this for more than 20 years and using the simple yoga poses proposed here to strengthen muscles on the convex side of the curve, have improved over 80% of the more than 300 patients we have treated.3-9

Three factors motivate the proposed study:

1. Although botulinum toxin has hastened improvement in curves in past studies , we have encountered significant resistance from intra- and interarticular ligaments, facet joint capsules, vertebral asymmetries and asymmetrical fascial tightening that tend to preserve the status quo, i.e., the scoliotic curves.
2. Being physically present in the operating theatre more than 100 times, we have observed the significant resistance to surgically straightening the spine that these structures offer, even with muscle-relaxing anaesthesia.
3. In the course of this work, we have found that the people in the earlier age groups in fact tend to reverse their curves more quickly and more completely than older patients.

Currently the yoga, done daily to increase the strength and endurance capacity of convex-side muscles, reduces lumbar scoliotic curves by 2.5-3.5% per month.3-9 We project that using isometric yoga poses in very young patients will not encounter the toughened resistance of ligaments, tendons and fascia that oppose the strengthening of the muscles of the convex side of the curve in older people, and thus will increase the efficacy of the treatment, and shorten the treatment period. This is particularly important since the curves are naturally smaller at earlier periods in a person's life, and are easier to straighten on that account as well.

Study Objective Visit Schedule and Endpoints:

The objective of the study is to determine if judiciously applied yoga will expedite improvement in scoliosis, and to quantify any improvement detected. Cobb angle measurements, the long-time standard for measuring the size of scoliotic curves, will form the basis of the data.

The intervention group patients will have in toto two scoliosis films and return for two follow-up visits: X-rays: 1) within 3 months prior to teaching, or within 72 hours afterwards, 2) Four months following teaching. Each control group patient will have in toto three scoliosis films and return for three follow-up visits: X-rays: 1) within 3 months prior to teaching, or within 72 hours afterwards, 2) four months following teaching the placebo protocol, 3) four months after beginning intervention protocol. The chief value of the later visits is to counsel the patients and their families and sustain the young patients' efforts. Patients and their consenting families will be notified of the results of all X-ray studies, of course.

The endpoint of the study is when the last Control Group patient has had her or his final X-ray, approximately eight months after entering the study.

Recruitment of Subjects:

The principal investigator's website has up to 5,000 hits daily, and a mailing list of nearly 15,000 names. In addition, he has 3,000 friends on Face Book, 4,500 on Linked in, and gives webinars that may be attended by as many as 1,500 people. He also sees scoliosis patients approximately three times weekly.

It is likely we will acquire the 28 patients needed for this study without further efforts.

Randomization

Patients will be randomized into one of the two groups of 14 patients each, using random.org. The office manager will keep a hidden folder on the status of each subject.

Sample Size, Power Calculation and Probable Attenuation:

Based on a previous study using the same yoga-like methods3-9 we did a power calculation with pre- and post-yoga mean Cobb angles differing by 15.1 degrees (40.9%) and a variance of 23.5, we calculated that an optimal study-group size was 9 subjects for groups I and II. This will give an 80% power and 0.05 alpha for two-sided student t-tests and should give sufficient sensitivity and specificity to avoid Type I and Type II errors.

Distinguishing significantly between those who did the yoga-like poses and those that did not, mean differences were 17 degrees, with variance of 23.5 and 18.5 for the groups respectively. This yielded a group size of 8 patients, using the same parameters for power and alpha. We also plan Mann-Whitney U test and Xi2 in our analysis.

Since dropouts averaged nearly 35 % in our clinical work, we set groups sizes at 12 subjects each. We will follow the subjects in the study more closely than is usually seen in plain patient care, making it likely that our dropout rate will not exceed 35%.

Safety Monitoring and Assessment Plan:

The safety profile of yoga in children is very good.10 Moderate and severe adverse effects cannot be expected in healthy 8 - 12-year-olds doing a long-established and patently safe yoga pose. Our study explicitly excludes neurologically altered individuals. In our own practice we have seen only minimal adverse side-effects in hundreds of individuals.2-7

The attending physician will evaluate and treat adverse side effects of a nature treatable in a private office. If further care is deemed advisable, the patient will be sent to the Cornell-Weill emergency department, which is 5-10 minutes away in heavy traffic.

Delayed reactions are extremely rare in yoga.9 We will encourage subjects to call us in the event of any unusual symptom or sign, painful or not, and will request an immediate visit to our office of those who, after evaluation, may reasonably require it.

Injury from the yoga-like isometrics is also rare. The pose included here is part of a program in which no significant injuries of any kind have been reported in over 10,000 hours of practice.10-12 We will go over the pose prescribed to each subject during our visit, and then will consult in person or through telemedical channels such as Zoom if further questions arise. Adverse effects will be analyzed and treated in the office and sent for further evaluation and possible treatment if there is reasonable expectation that this is necessary.

Expected Risks:

Participation involves very small but real risks. It is extremely unlikely but possible that hemorrhage, neurological injury, and even fracture could occur as the result of a fall. The possible injuries and their setting fall within the range of the risks of normal life. The risk of such injuries is small, and well within the limits of risks incurred in regular day-to-day life; every precaution will be taken by the experienced physician who has used yoga in his practice for decades.

In the growing medical literature focusing on yoga injuries there are no reports of injury due to the poses we use in this study.. Still, we will outline possible risks below.

1. Yoga Pose (Vasisthasana, the side plank) a. Falls i. A wall behind patient takes most risk out of this pose ii. Each patient will be taught by a certified yoga therapist or the physician. iii. This pose is done horizontally/diagonally on the floor, so falls are not from very high up.
2. Muscle strains i. The wall prevents the most likely cause of a muscle strain to the pectoralis or rotator cuff (backward fall) ii. Little muscular demand in the pose iii. This type of strain is self-limiting and very rarely needs medical treatment.
3. Joint pain i. The yoga pose is a stable, single position and is therefore unlikely to challenge the range of motion of young people. ii. Joint pain has been seen in this pose and is nearly invariably self-limiting and very rarely needs medical treatment. iii. Work arounds and adaptations are available within the context of the study, some of which do not involve the wrist or shoulder at all.
4. Yoga Pose Warrior II (Virabhadrasana II):
5. Falls i. Balance is critical in this demanding pose; a chair for beginners and a wall behind all practitioners limits the risk. ii. Each patient will be taught by a certified yoga therapist or the physician. iii. Intermediate versions are enable balance checks without danger of falling. b. Muscle strain i. Forcibly raising a belt may cause tennis elbow or supinator strain. ii. The quadriceps are quite active and might spasm. iii. We have seen none of these conditions in 25 years of teaching yoga to children and adults; if they should arise, they are well-treated by well-tested methods.
6. Joint pain i. This pose invites no excessive range of motion. ii. The pose is focused on strengthening, not stretching.
7. Half moon (Ardha Chandrasana):
8. Falls i. To reduce falls, participants first place one hand on the back of a chair, and progress slowly. Please see the appendix for details of the progression. ii. Participants soon learn to depend on a wall behind them, which is usually used in the classical pose as well as the remedial versions.
9. Muscle strain i. Pulling on the strap requires a good deal of tension, but one never sees cramping even in 70 - 80 - year-olds. ii. The elevated leg is so much stronger than the arm that it does not undergo much strain.
10. Joint pain i. We teach the arm hold the strap to be perpendicular to the torso, which is an unusual angle, but we have never seen rotator cuff tears or capsular tears such as SLAP tears. ii. Gradual progression in the forcible pressure on the strap is key. This has also never been a problem in people of any age. Protection of Confidentiality and Privacy: A pencil-and-paper list associating subjects' names with a six-digit number will be kept under lock and key at the Office Manager's office. It will be locked when not in use. Only numbers will be associated with the data we obtain in this study. Other data recorded for suitability in the study and for medical information and management will be either in paper or electronic form: Paper documents will be kept under lock and key in the office manager's office, which is itself locked when not in use. Many of these documents as well as the data collected in the study will be scanned in and kept on the physician's computer in the Criterions electronic medical record which is HIPAA compliant. Communication outside the office will be necessary only with respect to statistical analysis. The data sent will be anonymized (without names) and encrypted.