Study 1 included 126 patients (64 BOTOX and 62 placebo) with upper limb spasticity (Ashworth score of at least 3 for wrist flexor tone and at least 2 for finger flexor tone) who were at least 6 months post -stroke. BOTOX (a total dose of 200 Units to 240 Units) and placebo were injected intramuscularly (IM) into the flexor digitorum profundus, flexor digito rum sublimis, flexor carpi radialis, flexor carpi ulnaris, and if necessary into the adductor pollicis and flexor pollicis longus (see Table 25). Use of an EMG/nerve stimulator was recommended to assist in proper muscle localization for injection. Patients were followed for 12 weeks.
This medication can spread to other parts of the body after your injection, causing serious (possibly fatal) side effects. These can occur hours or even weeks after the injection. However, the chances of such serious side effects occurring when this medication is used for migraines or skin conditions such as wrinkles, eye spasm, or excessive sweating are extremely unlikely.
After an exam by a therapist and doctor, botulinum toxin for focal relief of muscle spasticity can be advised as the best way to address a child's functional problems. The problem muscle groups are identified, and goals for that child are discussed. Then the injection of botulinum toxin can be done if there are no permanent contractures of the muscle groups.
Exploratory analyses of this study suggested that the majority of patients who had shown a beneficial response by week 6 had returned to their baseline status by 3 months after treatment. Exploratory analyses of subsets by patient sex and age suggest that both sexes receive benefit, although female patients may receive somewhat greater amounts than male patients. There is a consistent trea tmentassociated effect between subsets greater than and less than age 65. There were too few non-Caucasian patients enrolled to draw any conclusions regarding relative efficacy in racial subsets.
When moving a spastic limb through its range of motion, one feels a resistance to movement that increases with the speed at which one moves the limb. This is the definition of spasticity, but other terms such as increased muscle tone, hypertonicity, spastic dystonia, or flexor / extensor spasms are used to describe this resistance. In clinic the term "muscle spasticity" will be used to reduce confusion of terms.
Botulinum toxin produced by Clostridium botulinum is the cause of botulism. Humans most commonly ingest the toxin from eating improperly-canned foods in which C. botulinum has grown. However, the toxin can also be introduced through an infected wound. In infants, the bacteria can sometimes grow in the intestines and produce botulinum toxin within the intestine and can cause a condition known as floppy baby syndrome. In all cases, the toxin can then spread, blocking nerves and muscle function. In severe cases, the toxin can block nerves controlling the respiratory system or heart, resulting in death. Botulism can be difficult to diagnose, as it may appear similar to diseases such as Guillain–Barré syndrome, myasthenia gravis, and stroke. Other tests, such as brain scan and spinal fluid examination, may help to rule out other causes. If the symptoms of botulism are diagnosed early, various treatments can be administered. In an effort to remove contaminated food which remains in the gut, enemas or induced vomiting may be used. For wound infections, infected material may be removed surgically. Botulinum antitoxin is available and may be used to prevent the worsening of symptoms, though it will not reverse existing nerve damage. In severe cases, mechanical respiration may be used to support patients suffering from respiratory failure. The nerve damage heals over time, generally over weeks to months. With proper treatment, the case fatality rate for botulinum poisoning can be greatly reduced.
The 5-unit dose that is injected at each site is a very low dose. Earlier studies with total dosing below 155 units failed to show separation from placebo. As a result, I encourage all patients to get a minimum of 155 units, even if they have a small frame. The optional component of the injection paradigm is the 40 units that are used for following the pain sites. The pain sites are the temporalis, occipitalis, and trapezius. These can be held if the injector is concerned. I do not reduce the dose below 155 units as lower doses have not separated from placebo, and thus I may not achieve an adequate headache effect with a lower dose. In fact, most of the time I increase the dose to at least 165 units, as this was the mean dose in the PREEMPT trials. I inject 5 units behind each ear for a bilateral headache and 5 units in two sites behind one ear in a side-locked headache.
30+ year migraine warrior, wife, mother, corporate exec turned health advocate, Paula is Migraine Again Managing Editor and Chief Encouragement Officer. She champions patient's needs as an American Migraine Foundation Board Member, CHAMP Coalition Leader, IHS Patient Advocate and co-author of CaMEO and My Migraine Voice research studies. In addition to hosting the Migraine Again Podcast and producing the Migraine World Summit, Paula is a frequent speaker at industry, health care and public policy events. She's also the Founder and CEO of the World Health Education Foundation, a 501c3. Follow her on LinkedIn or Facebook.
Much like other fillers, Botox is slowly metabolized in the system, so for it to remain effective, patients have to get the procedure every three months or so (however, as Ravitz told me during a recent visit, you can't get it done too frequently or your body will develop antibodies). I've now had four additional rounds of Botox since my initial procedure and have learned a lot about how my body reacts to it. Read on for both Ravitz's insight and information about my experience with five rounds of Botox.
Dosing in initial and sequential treatment sessions should be tailored to the individual patient based on the patientâ€™s head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history. The initial dose for a patie nt without prior use of BOTOX should be at a lower dose, with subsequent dosing adjusted based on individual response. Limiting the total dose injected into the sternocleidomastoid muscle to 100 Units or less may decrease the occurrence of dysphagia [see WARNINGS AND PRECAUTIONS].
Most insurance providers now recognize BOTOX as treatment for migraines. Some have specific criteria that patients must meet, or require documentation that you have gone through other treatment protocols before trying BOTOX. It can take several weeks to receive authorization to begin treatment. Check with your insurance provider to make sure you fulfill their requirements, and to begin the approval process.
If the musculature of the oropharynx and esophagus are affected, aspiration may occur which may lead to development of aspira tion pneumonia. If the respiratory muscles become paralyzed or sufficiently weakened, intubation and assisted respiration may be necessary until recovery takes place. Supportive care could involve the need for a tracheostomy and/or prolonged mechanical ventilation, in addition to other general supportive care.
Scientists at the University of Granada have confirmed that injecting a local anesthetic or botulinum toxin (botox) into certain points named "trigger points" of the pericraneal and neck muscles reduce migraine frequency among migraine sufferers. University of Granada researchers have identified the location of these trigger points -which activation results in migraine- and their relationship with the duration and severity of this condition.
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Table 14 presents the most frequently reported adverse reactions in a placebo-controlled, double-blind post-approval 52 week study with BOTOX 100 Units (Study NDO-3) conducted in MS patients with urinary incontinence due to detrusor overactivity associated with a neurologic condition. These patients were not adequately managed with at least one anticholinergic agent and not catheterized at baseline. The table below presents the most frequently reported adverse reactions within 12 weeks of injection.
The trapezius muscle is a large, triangular, superficial muscle. It attaches proximally in the medial third of the superior nuchal line, external occipital protuberance, nuchal ligament, and spinous processes of the C7-T12 vertebrae. Distal attachment of the trapezius occurs at the lateral third of the clavicle and acromion and spine of the scapula. The action of the muscle includes neck extension and stabilization of the scapula and support for the arm. The muscle fibers proximal to the inflection point of the neck (ie, necklace line) run vertically and are involved with neck extension. According to the PREEMPT injection paradigm, one injection of 5 units of onabotulinumtoxinA to each of three sites on either side of the trapezius, for a total of 30 units divided across six sites, is given. The first injection site can be identified by visually dividing the upper portion of the trapezius muscle in half, from the inflection point of the neck (ie the necklace line) to the acromion (acromio-clavicular joint); the midpoint of this location is where the injection should be administered. The second injection is located at the midpoint of the first injection site and the acromion. The third injection should be administered at the midpoint between the first injection site and the necklace line. Injections should occur in the supraclavicular portion of the muscle, lateral to the neckline, and medial to the deltoid and the acromio-clavicular joint. The injections into the trapezius should be administered horizontally and superficially to avoid injecting too deep.
BOTOX blocks neuromuscular transmission by binding to acceptor sites on motor or sympathetic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP -25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings. When injected intramuscularly at therapeutic doses, BOTOX produces partial chemical denervation of the muscle resulting in a localized reduction in muscle act ivity. In addition, the muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop. There is evidence that reinnervation of the muscle may occur, thus slowly reversing muscle denervation produced by BOTOX.
Botox is administered by injection and dosing depends on the condition that it is used for. Administration of botulinum toxin with other agents (for example, aminoglycosides, curare) that affect neuromuscular function may increase the effect of botulinum toxin. There are no adequate studies of Botox in pregnant women and it has not been evaluated in nursing mothers.
“Your doctor still has to be willing to do the work of filing a waiver and they don’t get reimbursed for that work, so they don’t like to do it,” Hoffman says. Plus, there’s a federal law called ERISA that exempts certain types of employer-provided health plans, called self-funded plans, from the requirements of state laws. So, for roughly a quarter of Americans who have these health plans, the state limitations to step therapy don’t apply.
Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX® 200 Units compared with placebo (1.5% versus 0.4%, respectively).
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
Dr. Matarasso says hardly a week goes by when he doesn’t see a patient with a botched Botox job. Why? People are getting it done by unexperienced, often unlicensed, practitioners who don’t know the shape of the face and how to correctly administer the toxin. “I just had a patient come in the other day who went to an ER doctor, and one that went to a psychiatrist,” he says. “They [also] have these Botox parties and I have seen scarring, significant bruising, not only functional, but aesthetic complications.”
When women in their 20's first consider getting Botox, prevention is often the primary factor, since the early signs of aging—such as crow's feet, forehead wrinkles, and fine lines—are beginning to show. "Lines get deeper and deeper with age," explains Wexler. "If you start [getting Botox] early enough and it's done properly, you're not going to need [as much] in the future." For younger patients wary of the frozen look—remember, youthful faces move—Wexler likes to employ lower doses of Botox via ultra-targeted micro injections administered on specific areas of the face such as the forehead, brows, or around the eyes.
If you experience migraine symptoms on 15 or more days each month, you have chronic migraines. Over-the-counter or prescription medications may help ease some of your symptoms, but some patients don’t respond well to pain relievers. In some cases, your doctor may prescribe preventive medicines, which are designed to reduce the frequency and severity of your symptoms. According to research published in the journal Neurology, only about one-third of patients with chronic migraines take preventive medicines.
How much is Botox is a frequent question we get in our dermatology offices. The cost of Botox runs typically about $400 – $600 per first treatment area, and up to $300 for each additional area. The most popular areas for Botox treatment are the glabella (those lines in between your eyebrows also known as the “11’s”), the crow’s feet are around the eyes and the horizontal lines on the forehead. When injected by a trained professional who has experience with facial aesthetics, Botox can also give the brows and eye area a mini eye lift. When Botox injections are performed by a trained, licensed and experienced medical expert, the results can be amazing. You will not appear frozen or as though you’ve had work done, when injected properly, Botox makes you look more relaxed, more rejuvenated and just better than before. It’s important to seek out a professional who knows about facial anatomy and can inject you in the exact right places.
I usually charge $12 a unit for botox. The number of units depends on the site. The "eleven" lines or glabellar area I usually use 20 units. Also I used 20-30 units for the forehead. In the crows feet I use about 15 units per side or 30 units total. To give a Botox brow lift I use 5 units total. Finally to give a patient a natural smile or soften the sad look of the mouth I use about 10 units. You can calculate the math to determine the cost depending on what you would like to get. Botox cost is going to vary by location as overhead will be different in different areas of the country. Maintaining a park avenue office is much more costly than an office in New Jersey so my price may be lower than someone in Manhattan. Someone in Bucks County Pennsylvania may have lower costs and thus lower prices still.
BOTOX was evaluated in two randomized, multi-center, 24-week, 2 injection cycle, placebo-controlled double-blind studies. Study 1 and Study 2 included chronic migraine adults who were not using any concurrent headache prophylaxis, and during a 28 -day baseline period had ≥15 headache days lasting 4 hours or more, with ≥50% being migraine/probable migraine. In both studies, patients were randomized to receive placebo or 155 Units to 195 Units BOTOX injections every 12 weeks for the 2-cycle, double-blind phase. Patients were allowed to use acute headache treatments during the study. BOTOX treatment demonstrated statistically significa nt and clinically meaningful improvements from baseline compared to placebo for key efficacy variables (see Table 24).
Properly trained, board-certified dermatologists and plastic surgeons separate the "forehead" area into the upper/main forehead, and the glabella, the area between the eyebrows that has the frown lines. Depending on your exact anatomy and types of lines and facial movement, you may need only 3 to 5 units total in the upper forehead area, or up to 40 units for the combined glabella... READ MORE
I always tell my patients that you get what you pay for. However, you need to advocate for yourself and understand what you are getting for your dollars. Ensure that your injector is experienced and properly trained; that you are getting FDA approved Botox Cosmetic from Allergan; and know how many units you receive. As well, a physician's office should maintain a medical record of your treatments so you can optimize and customize your Botox to achieve the best effect and value. Good Luck!
Risks are very minor with this procedure. The main risks consist of headache, pain, and flu-like illness. In rare cases, there may be a drooping lid or eyebrow area. It is important for the cosmetic surgeon to assess the patient's lids before injecting because the patient may not be a good candidate if he or she has an extremely droopy lid to begin with or one that is held up by constantly arching the lids. Ptosis (a severe drooping of the eyelid) can occur in up to 5% of patients but is very rare if the cosmetic surgeon does this procedure often. These complications are typically very minor occurrences and resolve with time.
Warnings and Precautions: In patients using LUMIGAN® (bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment of elevated intraocular pressure (IOP), the concomitant use of LATISSE® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN® for IOP reduction should only use LATISSE® after consulting with their physician and should be monitored for changes to their intraocular pressure.
Side effects from therapeutic use can be much more varied depending on the location of injection and the dose of toxin injected. In general, side effects from therapeutic use can be more serious than those that arise during cosmetic use. These can arise from paralysis of critical muscle groups and can include arrhythmia, heart attack, and in some cases seizures, respiratory arrest, and death. Additionally, side effects which are common in cosmetic use are also common in therapeutic use, including trouble swallowing, muscle weakness, allergic reactions, and flu-like syndromes.