The lay summaries for thoracic outlet syndrome and piriformis syndrome that follow are intended to familiarize potential subjects with the advantages and disadvantages offered by the study protocols.

Naturally people will have questions that are not addressed by the summary; those interested in participating in the study will have ample opportunity to ask the questions that arise, and evaluate the answers given by the researchers and/or their own or other physicians and scientists.

Please address any questions and comments to loren@sciatica.org.

Download the Consent Form Here

The study in which you are being requested to participate is designed to test the effectiveness of Myobloc (Botulinum neurotoxin type B) in treating shoulder, arm and hand pain, tingling, weakness and numbness due to thoracic outlet syndrome. It has been determined that you have thoracic outlet syndrome, and that treatment of this type is more likely to be effective for you than conventional treatments of other causes of these problems.

Myobloc is a commercially available form of Botulinum type B toxin, produced in accordance with the regulations of the FDA. It has been used as an injection for some years in the treatment of spastic torticollis, another neck and shoulder problem. Botulinum toxin A has been used for many years for this purpose as well as ocular muscular defects in children. It has been demonstrated to be safe with no known serious side effects.

The proposed mechanism by which Myobloc reduces shoulder, arm and hand pain involves the effect of Botulinum toxin on muscles. Botulinum toxin inactivates the myoneural junction, the connection between nerves and the muscles they activate, in the local area of injection. Since your type of thoracic outlet syndrome appears to be due to the overtightening of the thoracic outlet muscles, this inactivation is likely to loosen the grip of the muscles, and relieve the pain that the spasm had caused.

Myobloc has been studied extensively in the laboratory and in use with people. Its effects last an average of three months. Preliminary studies in people with thoracic outlet syndrome have demonstrated that Myobloc can relieve this painful condition in people for whom other therapies, however intensively applied, were of no value.

In the proposed study your physician will study the conduction velocity of the upper extremity nerves when the thoracic outlet muscles tend to stretch them, to determine whether the nerves are actually affected by the tightness of these muscles. Excellent laboratory data for this determination has been obtained from more than 100 patients and many normals over the last seven years.

If you are diagnosed with thoracic outlet syndrome, then you will be given an injection of either 2,500 or 5,000 units of Myobloc. Neither you nor your doctor will know which medication you have received, though the assistant preparing the medication (according to a prearranged, random schedule) will make careful note of it.

You will be offered physical therapy, which has been found somewhat helpful to patients with thoracic outlet syndrome, and asked to return to our offices at two weeks, four weeks, eight weeks, and twelve weeks. At each visit you will receive a physical examination, electrophysiological assessment of the nerve we are studying, and you will be asked to update a short questionnaire.

The final visit at 12 weeks will assess the effects, if any, of the treatment. If there is evidence of response to either the injections or the physical therapy, you will be given an opportunity to continue treatment. If there is no response to either the physical therapy or the injections, then therapy will be discontinued.

This is the "adverse effects" profile for Myobloc, the medicine that will be used in this study. This table contains data from people whose neck muscles have been injected with doses of the medicine equal to, and two times as great as those that will be used in your case, (depending upon which randomized group you are in).

Different Studies

Dry Mouth	3(3%)	1(3%)	8(12%)	36(34%)
Dysphagia	3(3%)	5(16%)	7(10%)	27(25%)
Cervical Dystonia	17(16%)	0(0%)b	11(16%)	18(17%)
Injection site pain	9(9%)	5(16%)	8(12%)	16(15%)
Infection	16(15%)	4(13%)	13(19%)	16(15%)
Pain	10(10%)	2(6%)	4(6%)	14(13%)
Headache	8(8%)	3(10%)	11(16%)	12(11%)
Dyspepsia	5(5%)	1(3%)	0(0%)	11(10%)
Nausea	5(5%)	3(10%)	2(3%)	9(8%)
Flu Syndrome	4(4%)	2(6%)	6(9%)	9(8%)
Torticollis	7(7%)	0(0%)	3(4%)	9(8%)
Torticollis Pain	4(4%)	3(10%)	3(4%)	7(7%)
Arthralgia	5(5%)	0(0%)	1(1%)	7(7%)
Back Pain	3(3%)	1(3%)	3(4%)	7(7%)
Cough increased	3(3%)	1(3%)	4(6%)	7(7%)
Myasthenia	3(3%)	1(3%)	3(4%)	6(6%)
Asthenia	4(4%)	1(3%)	0(0%)	6(6%)
Dizziness	2(2%)	1(3%)	2(3%)	6(6%)
Accidental Injury	4(4%)	0(0%)	3(4%)	5(5%)
Rhinitis	6(6%)	1(3%)	1(1%)	5(5%)

None of the side effects observed so far have any serious consequences. For example, in all the testing done in various locations around the world, no one has ever gone to the hospital as a result of a Myobloc injection. In general, the benefits of Myobloc injection far outweigh the adverse effects.

If you have further questions, comments, or suggestions, please feel free to let me know.

Very truly yours,

Loren M. Fishman,M.D.
Principal Investigator

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The study in which you may participate is designed to test the effectiveness of Botulinum toxin in treating buttock pain and sciatica due to piriformis syndrome. If it is determined that you have piriformis syndrome, then treatment of this type may be more effective than conventional treatments used in other types of lower back and sciatic type pain.

Botulinum toxin is a commercially available form of medication, produced in accordance with the regulations of the FDA. It is already being used as an injection in the treatment of spastic torticollis (stiff neck) in dosages equivalent to those used in this study.

The proposed mechanism by which Botulinum toxin reduces buttock pain and sciatica involves its effect on muscles. Botulinum toxins inactivate the myoneural junction, the connection between nerves and muscles, in the local area of injection. Since piriformis syndrome is due to the powerful tightening of the piriformis muscle, this inactivation is likely to loosen the grip of the muscle sufficiently to relieve the pain that the muscle tightness had caused.

Botulinum toxin has been studied extensively in the laboratory and in use with people. Its effects last an average of 3-5 months. Preliminary studies in people with piriformis syndrome have demonstrated that Botulinum toxin can relieve this painful condition in people for whom other therapies, however intensively applied, were of no value.

In the proposed study your physician will study the conduction velocity of the sciatic nerve when the piriformis muscle has been stretched across it, to determine whether the nerve is actually affected by pressure from this muscle. Excellent laboratory data for this determination has been obtained from more than 1000 patients and 88 normals over the last ten years.

If you are diagnosed with piriformis syndrome, qualify and wish to participate in this study, you will be given an injection of Botulinum toxin. You will be given physical therapy twice weekly which has been found quite helpful to most patients with piriformis syndrome, and asked to return to our offices at two weeks, four weeks, eight weeks, and twelve weeks. At each visit you will receive a physical examination and you will be asked to update a short questionnaire.

A final visit at 12 weeks will assess the effects, if any, of the treatment. Whether there is evidence of response to either the injections or the physical therapy, or not, you will be given an opportunity to continue treatment at a dosage to be determined by the study doctor. At the end of the twelfth week following the final injection, however, your participation in the study will have ended.

You may experience the following side-effects if exposed to Botulinum toxin treatment for piriformis syndrome: • Dry Mouth • Stiff Neck • Pain from the injection

These appear to be the most common side-effects. No patient in our experience has been seriously ill or hospitalized from an adverse effect of Botulinum toxin injection. These and all other adverse effects that we have encountered thus far are transient, though occasionally they may last for weeks. One case related to dry mouth lasted two months.

Dr. Fishman is a practicing physician with offices on Manhattan's Upper East Side and Upper West Side, Flushing, and City Island. He is President of Manhattan Physical Medicine and Rehabilitation, LLP. He has developed and tested effective techniques to diagnose and treat piriformis syndrome and other functional disorders, and applied yoga to sciatica and a number of other conditions such as arthritis, scoliosis, multiple sclerosis, osteoporosis and thoracic outlet syndrome. He has documented the benefits of these treatments as well as the efficacy of physical therapy and two types of botulinum neurotoxin in their treatment.

Dr. Fishman has been a specialist in electrodiagnosis of low back pain and sciatica for over 20 years. His other specialties are functional assessment, cognitive rehabilitation, and the application of yoga within the medical context. Over the last 10 years, he has lectured frequently and contributed over 60 publications. Back Talk, written with Carol Ardman, was published in November, 1997 by W. W. Norton, and again as Back Pain: How to diagnose and cure low back pain and sciatica in April, 2000. He and Ms. Ardman published Relief is in the Stretch: end low back pain through yoga W.W. Norton, in February of 2005, Sciatica Solutions: diagnosis, treatment and cure of spinal and piriformis problems, again with Ms. Ardman, W.W. Norton, 2006, and Yoga for Multiple Sclerosis, with Eric Small through Demos Medical Publishing in April of 2007. Yoga for Osteoporosis with Ellen Saltonstall, W.W. Norton, is scheduled for April, 2008, and 2009 should see Yoga for Osteoporosis.. Dr. Fishman is presently Associate Editor of Topics in Geriatric Rehabilitation, and on the Board of Advisors of the B.K.S. Iyengar Center of Greater New York. He is Assistant Clinical Professor at Columbia College of Physicians and Surgeons in New York City.

He has served as Medical Director of Abilities at the National Center for Disability Services in Albertson, New York, was Director of the Department of Rehabilitation at Flushing Hospital, New York, for 12 years, and has been affiliated with medical societies involving electrodiagnosis, low back pain and sciatica, physical medicine, rehabilitation, the aging, and home care. He was President, of the New York Society of Physical Medicine and Rehabilitation (1994-1995); and Chairman of the Executive Committee of the same society (1995-1996). Currently he is Treasurer of the Manhattan Institute for Cancer Research, a charitable organization.

After completing his General Medical Internship, in the Joint Tufts-Harvard Program at the Lemuel Shattuck Hospital in Boston, Dr. Fishman was Chief Resident in the Department of Rehabilitation Medicine at the Albert Einstein College of Medicine in New York. He received his M.D. degree in 1979 from Rush Presbyterian St. Lukes Medical College, Chicago, Illinois; earned his B. Phil. in the Philosophy of Mathematics from Oxford University, England in 1966; and a Bachelor of Science degree with high honors from the University of Michigan, in 1962.

Dr. Fishman is a co-author of the British Medical Journal's Review on Sciatica for Epocrates.

Dr. Kim completed her undergraduate training at the Massachusetts Institute of Technology, where she earned degrees in chemical engineering and biology. She then received her medical degree from the State University of New York Health Science Center at Brooklyn (Downstate) and completed her residency in Physical Medicine & Rehabilitation at New York Presbyterian Hospital at Columbia and Cornell Universities, where she trained in such advanced medical procedures as neurologic testing, pain management and trigger point injection therapy. Dr. Kim is a diplomate of the American Board of Physical Medicine & Rehabilitation.

Practice:
The focus of Dr Kim's practice is in Rehabilitation Medicine with an emphasis on back, neck, shoulder, hip, and knee pain. The goal of her treatment plans are pain reduction with restoration of functional ability. She keenly focuses on the needs of patients to return to full activity quickly. To this end, physical therapy is often prescribed as an important part of the patient's entire medical care. Underlying this approach is the firm belief that, prior to any consideration of surgery, every patient is entitled to and should receive multifaceted, noninvasive conservative care.

Dr. Mantell headed Beth Israel Medical Center's Uptown Hospital Department of Anesthesia for 15 years before joining our staff in 2004. She has done thousands of epidural injections, and worked in every area of pain management.

Dr. Miller received her graduate training in Physical Medicine and Rehabilitation at Mount Sinai Medical Center in New York, and has been in practice for the past ten years. Her special expertise in central nervous system and cranial syndrome is augmented by board certification in Pain Medicine and opioid addiction.

Phi Beta Kappa with Medical School and residency at Albert Einstein. Specializing in Geriatrics, musculo-skeletal diagnosis and treatment, post-operative care, EMG and Sports Medicine. Dr. Schwartz has worked with us for ten years, and has not stopped her studies. She has learned and now practices acupuncture as well as every aspect of rehabilitation medicine.

Tova has studied Paris, Maitland, Butler, McKenzie, Australian, and tuina approaches to musculoskeletal pain and pathology. She uses kinesiological and diagnostic analysis, specializing in joint manipulation and mobilization. Ms. Ovadia has profound knowledge of Sports Medicine and therapeutic techniques, including Yoga, Pilates, and other neuromuscular reeducation and integration, to promote proper biomechanics. Spin class instructor.

Previous faculty at NYU and Adelphi College, with B.A. from Hunter College and an M.A. in Exercise Physiology, Barbars is experienced in Geriatric and Women's Medicine, Orthopedics, and problems in runners and in the performing arts. She is an avid swimmer, runner and dancer. She has previously been physical therapist for the New York City Ballet. In the last five years Barbara has combined Physical Therapy and Pilates, applying them to musculoskeletal injuries, particularly in childhood dancers.

Kim has fifteen years' experience with Alexander therapy, and is certified by IRDEAT, itself approved by NASTAT. She has taught at NYU School for Film and Television, and for members of the New York City Opera. Kim is the most effective Alexander therapist we have ever known, by a sizeable margin. When she began with us she proved her mettle by curing most of the patients, inevitable in any practice, with whom everyone else had failed.

Mieke Haeck has been working with Manhattan Physical Medicine & Rehabilitation for two years. She graduated in 2001 from the University of Leuven in her native Belgium and specializes in Orthopedics and Manual Therapy. She uses modalities, manipulative manual techniques and extensive exercises to get maximal benefits for every patient in just about any condition.

Sanjay joined our staff after completing the course of study at Quinnipiac College's famed musculoskeletal program, and working with a number of different areas of Rehabilitation as a private practitioner. A highly creative adapter of these contemporary techniques to each individual's problems, Sanjay, a Texan, has shown particular success with scoliosis, spondylolisthesis and spinal stenosis.

After graduating Oberlin College with a major in dance and kinesiology, Paula has focused on using the Feldenkreis technique in healing. The process involves not-exactly-conscious retraining of movement patterns to simplify them and bypass the unnecessary and painful parts we inadvertently add and do not notice. Her work has been particularly successful with spasm, dyscoordination, and functional disability.

Ashwani has twenty three years' experience including Supervising P.T at New York Hospital for Joint Diseases, and Chief Supervisor, Abilities, National Center for Disability Services. Expert in all areas of musculoskeletal and physical medicine and rehabilitation; working effectively with babies, children, adults, athletes and performers, and older persons.

Caroline has more than twenty six years' experience in Physical Therapy. Specialties include Manual Therapy using the McConnell/Mulligan techniques , Upledger cranio-sacral methods, and the application of Yoga to gentle, firm guidance toward healing. Author of "The scope of physical therapy in antenatal and postnatal conditions."

Jayson has twelve years experience in physical therapy. Resourceful yet patient expert in gait disorders, disabling neuromuscular conditions, post-amputation and orthotic/prosthetic training, and skilled in all-around physical therapy, Jayson combines solid anatomical knowledge with contemporary physical therapeutic modalities and techniques.

Mr. Wood, a licensed massage therapist with an Associate in Occupational Studies degree from the Swedish Institute in New York, has 4 years of experience with traditional deep tissue therapeutics. His bodywork practice also incorporates Eastern modalities such as Thai Massage, Shiatsu, and the therapeutic principles of Anusara yoga.

A trained medical assistant with 25 years' experience, Pam runs the Lincoln Center office with an iron fist and a velvet glove. They have not invented an administrative problem that Pam hasn't seen and solved many times, in many ways.

Mr. Gomes has been a medical representative for pharmaceutical companies before joining our practice eight years ago, and managing the office in Flushing, Queens.

Mrs. Kalla has been a medical administrator for eight years, having worked at non-profit as well as privately run institutions. Before heading the Park Avenue office, she taught social studies in high school.

Mrs. Nevins has more than 35 years of experience in administration and management of medical rehabilitation. She is the general practice manager.