What
is an Anodyne?
Anodyne is a therapeutic device that delivers
monochromatic near infrared photo energy through high tech, light emitting
diodes (LEDS) in contact with the skin. The light is emitted by an array of 60 superluminous Gallium Aluminum Arsinide
diodes located on flexible pads, 4 1/4” by 2 1/4” (22 square an.).
Monochromatic means that the light emitted is within one specific wavelength,
namely 890 nanometers. 890 nm was chosen because of the depth of penetration
and high absorption because photo energy to be effective must be absorbed by
the target tissue. Since the photo energy (light) is infrared, it cannot be
seem.
The average energy emitted from the diodes is 9 milliwatts per square centimeter. The density of the photo
energy emitted per pad dining a 30- minute treatment is 43.2 Joule / square
centimeter.
Has
the FDA reviewed Anodyne?
In 1994, The FDA reviewed the 510 (K)
information submitted by Anodyne and issued its put-market approval letter.
This letter states that the manufacture may claim that this product temporarily
increases circulation and reduces local pain.
The Anodyne Therapy System is a Class II, non-invasive medical device
cleared for marketing by the FDA in 1994 for increasing circulation and
reducing pain. The Anodyne device is
covered under US Patent Number 5,358,503.
What
happens when the Anodyne unit is used?
The diode array creates a comforting warm feeling under
the pads. The photo energy (pad heat) dilates the
blood under the vessels increasing circulation. The light (and heat) also
reduces pain. Additionally, patients experience a decrease in local welling,
decreased inflammation, decreased muscle spasm, decreased tension and muscle
tightness, increased range of motion, increased lymphatic drainage and
increased venous dilation and flow.
Diabetic patients with peripheral neuropathy typically experience au
increase in sensation to pressure and hot/cold.
How
does Anodyne reduce pain and increase circulation?
The photo energy releases a free radical molecule called
nitric oxide from the hemoglobin and possibly surrounding tissue. Nitric oxide
is a signaling molecule that is known to relax smooth muscle cells found in the
arteries, veins, capillaries and lymph vessels. When these muscles relax, they
dilate the blood vessel, thus allowing increased circulation. Nitric oxide has
been shown to be essential for wound healing even if chronic or traumatic.
Scientific literature shows that nitric oxide promotes collagen synthesis,
collagen synthesis, collagen fibril alignment, and angiogenesis. Nitric oxide is also a neurotransmitter.
Have
increases in circulation associated with Anodyne ever been measured?
Yes. Tests have been conducted with a scientific
instrument known as a scanning laser Doppler, which measures circulation at 1
to 2 millimeters (microcirculation). These tests demonstrate increases from
400% to 3200% after just a 30 minute Anodyne treatment. Please note that
comparative increases in circulation using heat or ultra sound are
substantially less than those observed with Anodyne
Are
there any known adverse side effects with using Anodyne therapy?
Not if used with manufacturer’s
instructions for use. The manufacturer, (or liability reasons, does not
recommend its use where there is an active malignancy or for patients who ant
pregnant since other modalities are likewise not recommended in these
situations.
Note: diabetic patients should closely monitor their
insulin levels during treatment as some patients require less insulin and may
need to adjust their insulin dosage to prevent hypoglycemia.
