Effective Relief from Chronic Pain

The TriMED TENS helps to relieve the symptoms of chronic pain that many live with every day.

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Get Relief from Chronic Pain

The TriMED TENS helps to relieve the symptoms of chronic pain that many live with every day.

Read more

Effective Relief from Chronic Pain

The TriMED TENS helps to relieve the symptoms of chronic pain that many live with every day.

Read more

Effective Relief from Chronic Pain

The TriMED TENS helps to relieve the symptoms of chronic pain that many live with every day.

Read more

Effective Relief from Chronic Pain

The TriMED TENS helps to relieve the symptoms of chronic pain that many live with every day.

Read more

Effective Relief from Chronic Pain

The TriMED TENS helps to relieve the symptoms of chronic pain that many live with every day.

Read more

Effective Relief from Chronic Pain

The TriMED TENS helps to relieve the symptoms of chronic pain that many live with every day.

Read more

Effective Relief from Chronic Pain

The TriMED TENS helps to relieve the symptoms of chronic pain that many live with every day.

Read more

CES FAQ

What is CES?
CES provides small pulses of electric current across the head for the FDA recognized treatment of anxiety, insomnia and depression. The current is up to but usually no more than 1.5 Milliamperes powered by nine-volt or AAA batteries.
What it Does:
The theory is that CES stimulates each neuron to increase the manufacture and use of its neurotransmitter until all of them achieve mutual inhibition of each other’s further production. This leaves the patient in the pre stress level of homeostasis (balance).

Pulse Characteristics:
The CES devices used in most U.S. studies pulse at 0.5 Hz, or 100 Hz, with either a sinusoidal or a modified square wave. Current intensity is set below sensation threshold, usually around 100 microamperes, and the device is on a 20% to 50% duty cycle, with a peak voltage of 11 to 14 volts.

Change in EEG:
EEGs of pain and high stress patients are typically somewhat erratic, with a large root mean square deviation around their mean spikes. CES smoothes this out, reducing the dramatic fluctuations around the mean, similar to that of pain free, and low stressed persons.

History:
CES has been in the U.S. since the late 1960s, known at first as Electrosleep; the name was changed by the FDA to Cranial Electrotherapy Stimulation, in 1978. FDA permits its marketing in the U.S. for the treatment of anxiety, depression and insomnia

Research:
Presently there are more than 100 human and 20 animal studies appearing in the U.S. literature. At any given time, more than 5 additional open clinical, and double blind studies are underway in the U.S., Europe, and around the world. References are available by calling 800-488-8492.

Is CES Safe?
To date, more than 5,000 people have been involved in CES research, and no significant negative side effects have been found in any of the participants. A few patients have reported a slight headache, which can be alleviated by turning down the intensity.

CES has an unblemished safety record. It is not harmful even when turned to maximum intensity.  Although most patients like to feel something, it is not necessary to feel the current for it to be effective and it is not necessary to turn it up to maximum.

How does CES Affect Sleep?
Typically, sleep patterns begin to normalize within a day or two with less and shorter periods of awakening during the night, faster onset of sleep, and a greater feeling of being rested upon awaking in the morning.

Does CES work for Everyone?
Nothing works for everyone, but CES is effective for most people.

In his book “Cranial Electrical Stimulations: Its First Fifty Years, Plus Three” by Ray B Smith, PhD, he reports five meta-analyses of Cranial Electrical Stimulation (CES) covering various human clinical trials that have been published in the US scientific literature.  Each meta-analysis focuses on a particular treatment indication, as follows:

1. Insomina: 18 studies, 648 subjects, mean improvement 62%.
2. Depression: 18 studies, 853 subjects, mean improvement 47%.
3. Anxiety: 38 studies, 1495 subjects, mean improvement 58%.

Why is CES important in treating chronic pain?
It has been theorized that CES is effective in pain treatment because it is known to relieve stress, and stress is known to be a strong correlate of the perception of pain in pain patients.  Additionally, studies suggest that poor sleep can exacerbate chronic pain, CES, by helping with sleep issues, may help to lessen chronic pain.

Recently, it has been shown that pain also frequently accompanies depression, which CES is known to treat very effectively. In one study more than 75% of patients being treated for depression reported experiencing chronic or recurring pain and 30% to 60% of pain patients also reported significant depression.

Does Insurance Cover the FM 10/C?
If the patient has Durable Medical Equipment (DME) coverage, most insurance carriers will cover a TENS unit for a chronic pain diagnosis. They will not cover a TENS or CES for a mental health diagnosis. The FM 10/C is classified as both a TENS and CES unit and should be covered by most carriers if ordered by a physician and medically necessary to treat chronic pain.

Therapeutic Resources, Inc. (TRI) is in network with most carriers including Medicare, Blue Cross, Blue Shield and Tricare and provides insurance billing. TRI is Medicare accredited.

Patients are welcome to call Therapeutic Resources, Inc. at 800-488-8492 to find out about their individual insurance coverage. The amount of reimbursement depends on the individual plan.

What immediate results should be expected?
Most people experience a positive response almost immediately and others after several days. The relaxed but alert state will usually remain for an average of 12 to 72 hours after the first few sessions.

How often do patients use CES and how long do the effects last?
Both of these are very individual. Some people will experience results very quickly and others will experience results in a day or two. After regular use, patients will usually use the unit every other day or even 2-3 times a week.

How long is the treatment and how long can I use it at one time?
This is also dependent on the patient. Some patients will use it for 30-60 minutes and others, such as those diagnosed with Fibromyalgia, may wear it for several hours at a time and in some cases daily.  You should consult with your health care practitioner for treatment protocol.

What CES units are the best?
The most significant research on CES is based on the traditional 100Hz configuration. There is also research on units with less than one hertz.

Is CES Approved by the FDA?
Unlike the process that a pharmaceutical company must go through for approval for a new drug, a medical device manufacturer must go through an entirely different process unless it is a completely new device and in a new category. In that case, the device goes through the Pre-market Approval Process (PMA) including clinical trials, just like a pharmaceutical company does with a new drug.

If a similar device is already on the market (called a predicate device), a medical device manufacturer goes through a 510(k) process. In this process the FDA determines if the new device is substantially equivalent (SE) to the predicate device that is currently being sold.

This also means any studies and science that have been published apply to all devices in that same substantially equivalent category.

All CES devices on the market today have a 510(k) against the original Neurotone Device that was grand fathered when the Device Amendment was passed in 1976, which was on the market before the law was passed. Therefore, they are all considered substantially equivalent (SE) by the FDA.

The FM 10/C is cleared by the FDA as both a TENS and a CES device. 510(k) #K090052