On Label and Off Label Uses Of Microcurrent Devices

The FDA approves electrical stimulation devices for sale in the United States for for "the symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post surgical traumatic pain problems." Manufacturers of microcurrent and other electrical stim devices are only allowed to advertise and promote their devices for these approved uses. These are what would be called "on label" uses of the devices.

Medical devices and approved pharmaceutical drugs are often used by doctors for uses not approved by the FDA. These are called "off-label" uses. A high percentage of health care and esthetic practitioners use microcurrent devices for a wide range of off label uses, including non-needle acupuncture, treatment of macular degeneration and other eye diseases, facial rejuvenation, wound healing and fracture acceleration, TMJ syndrome alleviation and even relief of many internal organ and emotional disorders. These off-label applications are used with particular frequency by acupuncturists, who are used to using stimulation through the acupuncture meridian system for treatment of a host of physical and emotional diseases.

So the question is- are you within your legal rights to use your microcurrent stimulator for these off-label uses?

The term "IRB" refers to Investigational Review Board - a lengthy procedure required for proving new medical claims:

"Does FDA require IRB review of the off-label use of a marketed device?" YES, if the off-label use is part of a research project involving human subjects. NO, if the off-label use is intended to be solely the practice of medicine, i.e., for a physician treating a patient and no research is being done. The FDA recognizes that off-label use by prescribers is often appropriate and may represent the standard of practice."

There is a provision in the Federal Food, Drug, and Cosmetic Act that allows a practitioner to use a cleared device for an unapproved or 'off label' use." There are a number of restrictions that do apply in this case. The practitioner can only use the device "off label" in a legitimate practitioner-patient relationship. They may not advertise or promote the "off label" use of the device in their practice, and the manufacturer may not promote, advertise, or label the device for the "off label" use.

This is very clear. If you are a licensed health care practitioner whose scope of practice includes electrical stimulation, you may use a microcurrent device for any safe off-label application that you deem appropriate in the doctor-patient relationship. You are NOT legally allowed to advertise these off-label uses.

This advertising restriction only applies to advertising the electrical stim device for an off-label purpose. You can advertise treatment of any disease that you are legally allowed to treat. For acupuncturists or physicians, that is just about anything.

So what about microcurrent facial rejuvenation treatments? According to the FDA guidelines, you technically should not advertise the use of a FDA-registered microcurrent device for facial rejuvenation services, although you are free to use it with your patients. Yet the FDA does allow estheticians to advertise the use of microcurrent devices that are not FDA-registered for rejuvenation. They are the same technology! In actual practice the FDA has not bothered health care practitioners using or advertising microcurrent devices for facial rejuvenation due to these ambiguities. I have personally spoken with many FDA workers at various departments about this subject, and they all basically punt on the subject as they don't want to have to deal with it. The best opinion I could get was that it is OK to use microcurrent and light devices for rejuvenation as long as no medical claims are made for the procedure.

It would certainly be a no-no to use the word "face-lift" in any advertising, but rejuvenation, toning, revitalizing and similar words are perfectly OK.

For more information about microcurrent and light therapies visit http://www.eastwestseminars.com or call 1-888-803-7397

A Fitness Rowing Machine For Joint Health

Many people who use equipment to exercise and stay fit have all reported getting great results while using a fitness rowing machine. The stationary rower is great in that it simulates a real rowing experience. Some even have water sounds that make the work out seem more like the real thing. For those that would prefer to be out on the water this feature an asset. Rowing is one of the safest and best ways to become fit, or stay fit.

When one rows they are exercising many muscle groups at one time, with no strain on the joints. For those that are older or have problems with their joints, using a fitness rowing machine provides them the low impact work out that they need. Exercising and working out can be very hard on the body, so using equipment that is low impact seems to make working out less like work. Some people that are very limited due to disability find that a fitness rower is a great way to get exercise in your home without hurting themselves in the long run.

There are many companies that make these rowers, and as usual, some are better than others; but all have one goal in mind and that is to provide a low impact but effective method of working out. Some machines can be bought in brick and mortar stores, however they can also be ordered online through retailers. There are many different types of rowers to choose from whether it's an air rower or the type that simulates the real deal. To advise on a couple of the most popular there is the Fitness Quest Integrity 3000 Air Rower, and the Stamina 1205 Precision rower. These fitness rower machine brands seem to get good reviews from those that have bought them.

There are many other brands to choose from, however when deciding on which one it is advisable to be a consumer conscience person by researching each brand and model that is of interest to avoid buying one that may not be suitable down the road for whatever reason. Those that are lacking space need to concentrate on buying a fitness rowing machine that can be easily stored or left out without taking up too much precious room space. No matter the choice of rowing machine, making the decision to buy one is the first step to a lifetime of fitness.

If You Are Suffering From Joint Pain and Allergic to Shellfish, Glucosamine May Be Deadly

Pain is a common side effect of growing old. You become more sedentary, and your ligaments, tendons and muscles begin to be less forgiving and cartilage begins to erode due to normal wear and tear or age related disease.Many people who suffer from joint pain use glucosamine as a popular supplement, but proper research should be followed on the products you are considering.

Knees, elbows, ankles and wrists can all become affected by joint pain and tenderness just by doing daily activities. Stiffness and related symptoms become more commonplace as you begin to feel old age creeping up.

To combat this, many are turning to technology and medical supplements to help deal with this daily issue. Glucosamine is one such product people turn to help them deal with joint related problems. Glucosamine is part of the normal make up of cartilage, which is tissue that exists between your joints. Cartilage is a thick substance that provides a protective buffer between working joints like wrists and knees.

Some glucosamine products can come from the exteriors of shell fish which can be very dangerous to those who suffer from shellfish allergies. Without even knowing it, an allergic reaction can be triggered by taking a supplement to assist in joint health. Proper care should always be taken when looking for new products and a physician should always be consulted to ensure products and effects are safe.

In summary, glucosamine for joint pain is a popular over the counter treatment, but care should be taken in selecting the right product for your health and wellness program. Exercise and diet should be the first areas to be addressed as part of your intent to become more healthy and pain free.

How Joint Injections Help Athletes

Joint injections are common procedures in medicine where medications are injected into the joint space. This procedure is uncommon in younger athletes, due to their normal and healthy joint functions. However, this is one of the most reliable methods of managing degenerative arthritis or osteoarthritis in many older athletes.

Benefits of joint injections

The procedure is given to treat inflammatory joint issues such as gout, rheumatoid arthritis, tendonitis, psoriatic arthritis, bursitis and sometimes osteoarthritis. Corticosteroids are used for this medical procedure because of its anti-inflammatory capability as well as its ability to slow down the build-up of cells which causes the inflammation in the joint space. If present, joint fluid will be aspirated or removed prior to joint injection. This also eases the pain and swelling of the join and helps in the diagnosis of joint pathology.

While corticosteroids may successfully relieve osteoarthritis, the mode of action as to whether this will aggravate or alleviate the issue is unclear. In many knee-joint injection procedures, Hyanluronic acid, a viscous lubricating substance, is commonly used to relieve the symptoms of osteoarthritis of the knee.

What Comprises Joint Injection Medications

The anti-inflammatory medication corticosteroid is mostly utilized in this procedure. Cortisone is a kind of steroid that it naturally produced by the body and released when you are under stress. Injectable cortisone is synthetically produced and it's a close derivative of the natural cortisone. Unlike natural cortisone, corticosteroids are injected to specific inflamed areas instead of being released into the bloodstream. This synthetic cortisone is also more potent and provides relief for a long period of time.

Apart from synthetic cortisone, a lubricant such as hyaluronic acid injections works to lessen the inflammation and lubricate the affected joint. It helps the joint lining to produce substances to feed the joint cartilage. This actually helps in early arthritis can is effective up to 6 months. Patients are given joint injections once a week for the next three to five weeks and this process maybe repeated after six months if needed.

Which joints are injected?

The most commonly injected joints are the ankle, knee, shoulders, elbows, wrists as well as the small joints of the hands and feet. You may need an x-ray called fluoroscopy to guide hip-joint injections.

Unlike oral steroids which are mostly abused and misused by athletes, joint injections using corticosteroids can lessen healing time and help lessen pain and inflammation. This procedure is mainly used to treat inflammation of the joints in sports injuries and aging athletes with their arthritis. Despite its many benefits, injection and these steroids also have corresponding side effects depending on the amount and location of the joint injection as well as the condition of the patient.

Introduction to Platelet Rich Plasma Therapy for Joint and Back Pain

Platelet rich plasma therapy (PRP) is a new and innovative treatment that naturally heals injured joints and tissue by using the body's own healing process. PRP therapy can be used in patients suffering from joint and knee pain, lower back pain, rotator cuff tears and other orthopedic type injuries. Many clinical studies have shown the benefit from using platelet rich plasma for the non-surgical treatment of these conditions.

Joint pain, particularly in the knees and shoulders as well as back pain constitute the large majority of patients who present to their doctor's office with a complaint of pain. Many of these patients proceed to have surgery, all too often with less than optimal outcomes. Many of these patients still have the same pain they had prior to surgery, or worse, more pain. They are in chronic pain and are frustrated that no one can help them. They are amazed that surgery did not fix them. Platelet rich plasma therapy offers these patients with joint and back pain relief by healing damaged knee or shoulder joint tendons, ligaments and cartilage. Patients with back pain benefit by PRP repairing damaged ligaments and muscles.

Patients with persistent back pain frequently feel that surgery was the only option that they have. Unfortunately all too many patients fall into the trap that surgery is the only answer to their pain problem and were convinced that surgery would "cure" their pain. The most unfortunate thing is that surgery was most likely not appropriate for them in the first place. Surgery will, more frequently than not, fail to relieve spine pain. That is because in the majority of the time, back and neck pain are not due to a spinal problem. The problem most likely due to soft tissue pain: muscles, tendons, ligaments and fascia (the cover tissue of muscles).

Platelet rich plasma offers patients an effective therapy to relieve their pain without surgery or narcotics. This incredible therapy was never taught in medical school. Basically platelet rich plasma therapy (PRP) uses your body's own natural healing process to repair damage tissues.

To make PRP, two ounces of your own blood is taken and processed to extract out PRP. In whole blood, PRP is only one percent volume of the blood. With platelet rich plasma processing, we can concentrate platelets by 500-600%. This concentrated platelet rich plasma can then be injected directly into the area with damaged tissue. This may be in the knee or shoulder joint, lower back, neck or into injured tendons or ligaments.

In patients who have bone fractures, PRP dramatically accelerates bone healing and pain relief. Platelet rich plasma therapy is a remarkable treatment. It clearly helps patient to avoid surgery, has no recovery time and uses the body's own healing mechanism to get natural, stronger healing.

This therapy has been widely used by pro athletes, including players in the NFL such as Super Bowl player Hines Ward of the Pittsburgh Steelers. Major League Baseball superstar and Yankees third baseman Alex Rodriguez has received PRP therapy. Perhaps most famously, pro golfer Tiger Woods received this therapy for his knee pain.

Causes of Elbow Joint Pain

There can be a number of conditions and diseases which can cause pain to the elbow joint. Most people associate chronic joint pain with arthritis, but you should always consult your doctor to determine the cause of elbow joint pain. One of the more common causes is bursitis-a painful disease that affects many people each year. Trauma and overuse can leads to bursitis.

What Is Bursitis?

A bursa is a small sac filled with fluid. When functioning normally, the bursa releases fluid which lubricates the joints and allows them to glide smoothly. When the bursa is injured, the sac no longer releases the fluid and your joints begin to rub against each other, causing friction and pain.

Elbow Joint Pain

Although you cannot feel it, the elbow bursa is located behind your elbow, over the pointed tip. Bursitis to the elbow is referred to as olecranon (oh-LEK-rah-non) bursitis. This is normally a result of repetitive movement or prolonged, excessive pressure to the area. People who perform repetitive activities, such as tennis players or construction workers, commonly develop this condition.

High Risk Factors

There are a number of medical conditions which place people at higher risk for bursitis:

* Diabetes
* Alcoholism
* Steroid therapy
* Trauma
* Uremia
* Skin disease

How to Treat Bursitis

There are several treatments for bursitis pain, ranging from rest to surgery. Treating physicians normally start with conservative therapy and move on to more aggressive treatment if necessary.

R.I.C.E. Therapy: Rest, Ice, Compression, and Elevation is the most common treatment for bursitis pain. Depending on the severity of your elbow joint pain, this may or may not be successful.

Steroids: Your medical doctor can prescribe medications to reduce the pain and swelling. Corticosteroids, which can be injected directly into the affected site, are widely recommended because they attack the problem and relieve the symptoms more quickly.

Joint Therapy/Exercises: Your doctor may recommend physical therapy or a home exercise program to strengthen the muscles. They may offer a corticosteroid injection with therapy, which in many cases offers immediate relief.

Medications:

NSAIDs-Anti-inflammatory medications such as aspirin, ibuprofen, or naproxen may be helpful in relieving bursitis pain.

Antibiotics-In cases of infectious or septic bursitis, fluid is usually collected for lab analysis and antibiotics are required. Depending on the severity of your condition, intravenous antibiotics may be necessary.

Alternative Medicine-There are a number of all-natural supplements on the market, such as Celadrin, which are known to promote joint health and have seen excellent clinical results.

Invasive Treatments:

In some cases, the bursa fluid may have to be aspirated or removed with a needle and syringe. The fluid is then sent to a laboratory for analysis. In severe or repeated cases of bursitis, surgical drainage and removal of the infected bursa (bursectomy) may be required. In most cases, the joint functions normally after the procedure.

Once you know the causes of your chronic joint pain, the good news is that it can be treated. The first step is getting the proper diagnosis from your physician.

What is Neuromuscular Dentistry

The primary element which sets neuromuscular dentistry apart from traditional dentistry is that neuromuscular dentistry considers the nerves and muscles and the correct positioning of the jaw, whereas traditional dentistry focuses on just the teeth and joints.

The result is a more complete approach which can resolve painful conditions such as temporomandibular joint disorders and provide more comfortable and longer lasting solutions to other dental needs such as dentures and smile makeovers.

Your teeth, joints, muscles, and nerves all work together in the proper alignment and functioning of the jaw. When any part of this equation is overlooked painful conditions such as TMJ and serious dental problems can develop. Neuromuscular dentistry utilizes modern technology to precisely determine the proper positioning of the jaw.

· Electromyography
Electromyography measures the electrical activity in the jaw muscles and the jaw-to-skull relationship. This determines muscle tension when the jaw is in motion and in a relaxed position.

· Computerized Mandibular Scan
The mandibular scan precisely tracks all of the motions of the jaw and the position of the jaw at rest.

· Sonography
Sonography records all of the sounds of the jaw while it moves. Clicks, pops, scraping, and grinding all are sounds of misalignment (malocclusion).

TMJ/TMD
The most life-changing effect of neuromuscular dentistry is its ability to prevent, diagnose, and treat TMJ/TMD. A misaligned jaw has far reaching ramifications that can present themselves as painful and debilitating symptoms which seem to have no relationship to dental problems. TMJ/TMD symptoms include:

· Headaches (often misdiagnosed as migraines)

· Shoulder, neck, or back pain

· Numbness in arms and fingers

· Facial pain

· Jaw pain

· Clicking or popping jaw

· Clenching or grinding teeth

· Ringing ears (tinnitus)

· Congested ears

In the treatment of TMJ/TMD a neuromuscular dentist will use transcutaneous electrical neuromuscular stimulation (TENS). This treatment acts like a massage, relaxing the muscles, stopping spasms, and relieving pain.

Smile Makeover
A smile makeover addresses all aspects of your smile including your teeth and gums, and should include proper jaw alignment. Neuromuscular dentistry ensures that a smile makeover is complete and achieves not only the optimum functional dental benefits, but the cosmetic benefits as well. When your teeth and jaws work together properly, the muscles are relaxed and the effect can take years off of your appearance. A misaligned bite can lead to future damage, including chipped and broken teeth, quickly diminishing the results of a smile makeover and requiring unnecessary painful and costly dental work.

Dentures
Traditional dentistry relies on impressions to create dentures. Using impressions alone can lead to subtle imperfections and does not create a precise bite alignment. Neuromuscular dentistry eliminates many of the problems commonly associated with dentures including difficulty chewing and speaking, and can extend the length of time that the dentures will fit properly before they must be replaced.

Neuromuscular dentistry is a more advanced, effective, and complete approach to dental treatment than traditional dentistry. TMJ/TMD treatment can quickly relieve life-long pain. In general dentistry procedures the results are more accurate and long-lasting. When applied to cosmetic dentistry a more beautiful look can be achieved.