The Science behind Electrotherapy

The Gate Control Theory

The gate control theory hypothesizes that nerves are only able to carry one signal at a time. By over-stimulating those nerves with electrical current the TENS unit is able to confuse the brain and, thereby, block the real pain signals from getting through.

The Endorphin Theory

The second theory is the TENS unit stimulates the production of the body’s own natural morphine-like substances known as endorphins. It is believed that electric current stimulates certain nerves, which in turn send messages to the brain causing it to release these natural pain relief chemicals. These endorphins then act in a similar manner to conventional narcotics to provide the body with overall pain relief.

What kinds of pain respond to TENS?

Pain that warns us of external danger and internal illness serves a useful purpose. However, the chronic and acute pain associated with long-term illness, surgical incisions, and unknown diagnoses do not serve a purpose. TENS is an excellent, non-drug alternative for chronic pain. It is also useful in relieving acute pain associated with surgery, traumatic injury, and other conditions.

How can TENS relieve pain?

TENS can relieve pain by blocking the pain message sent by the body’s nervous system. This is accomplished by placing electrodes over the painful area and administering a low-volt electrical current. The current overrides the nervous system’s message of pain, thereby blocking it.

Does TENS treatment have any risks or side effects?

Unlike surgery or prescription drugs, TENS is virtually risk free from injury, side-effects or addiction. The low volt electrical current delivered by the electrodes only penetrates the skin to the level of the nerve fibers, usually only one to two inches. This poses no danger to most individuals. However, those with cardiac conditions and/or pacemakers, and pregnant women should consult their doctors before using TENS; the use of TENS is not generally advised. Also, using TENS for neck and head pain should be conducted only with the consent of a physician. Use caution when you drive or operate heavy machinery. Most importantly, always use TENS according to your physician’s directions.

What is the most effective way to use TENS?

To achieve the best results of TENS therapy, it is important to remember that TENS merely activates the body’s own pain-fighting mechanism. Placing electrodes directly over or around the painful area delivers pain-blocking current to the nerves leading to that area. Some healthcare professionals have found that placing the electrodes along acupuncture points and meridians is also effective. Also, it is good to vary the placement of the electrodes each treatment to avoid skin irritation.

How long does it take for TENS treatment to produce results?

In most cases, studies show that it takes roughly 30 minutes for TENS treatment to begin to relieve pain. However, for conventional, high-frequency TENS treatment, there is no set treatment limit. Some patients find hours of pain relief from short 30-to-60 minute sessions. Others use their TENS units for several hours a day or all day, depending on the pain generated by daily activities. Always use your TENS unit according to your physician’s directions.

When can TENS treatment be administered?

TENS can be administered any time of day or night. It is recommended that TENS not be used while sleeping because movement during sleep may cause electrodes to come off or be pressed into the flesh, causing skin irritation. However, always use your TENS unit according to your physician’s directions.

Medical Device Regulations by Region

All medical devices, like medications, are required to comply with the regulations of the country in which it is sold. Countries may borrow or emulate the regulatory requirements of another; therefore, we see regulatory similarities throughout the world. Most regions use a device classification to determine the process by which the device manufacturer must take to legally sell and market a device in a country. A detailed explanation is provided below for the U.S.

United States – The WellnessPro is FDA Cleared as a Class II medical device.

The U.S requires medical device manufacturers implement a quality system under 21 CFR Part 820 and submit a 510(k) Premarket Notification. The U.S. FDA 510(k) Premarket Notification submission requires medical device manufacturers to demonstrate that their device is safe and effective by providing substantial equivalence to an already legally marketed device. The U.S. classification system differs from Europe in that the manufacturer does not use a rules based system, but rather a substantial equivalent device to determine classification. If no equivalent device exists, a classification decision is made by the FDA. Device manufacturers are required to address and submit testing results, clinical data, validation, etc. as part of this 510(k) submission. If the FDA approves the device submission, the device is issued a 510(k) clearance letter and the medical device manufacturer is able to legally market and sell the device in the U.S. The U.S. FDA quality system requirements (21 CFR Part 820) were created many years before ISO 13485. Furthermore, unlike ISO 13485, there is no quality system certification program and no quality system compliance certificate is issued by the FDA. Instead, the FDA conducts random inspections to determine compliance with the quality system requirements (21 CFR Part 820).