BioModulator (TM) Acupuncture RCT

“A Randomized Study Comparing the Tennant BioModulatorTM to Transcutaneous Electrical Nerve Stimulation (TENS) and Traditional Chinese Acupuncture for the Symptomatic Treatment of Chronic Pain Among Injured Service Members”

The purpose of this research study is to determine which of the three non-traditional pain treatments: (1) the Tennant BioModulator, (2) Transcutaneous Electrical Nerve Stimulation (TENS) or (3) Traditional Chinese Acupuncture, is most effective for the management of chronic pain among injured Service members. We will also evaluate Sleep, Post Traumatic Stress Disorder (PTSD) symptoms, and Depression Scores.

This randomized control trial began fall 2009 with an N of 100. Subject recruitment completed 27 September 2013 with the last one-month follow up appointments in December 2013. Subjects made a total of 7 visits to the pain clinic (six 1-hour weekly visits and a one-month follow-up visit).

Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive therapy indicated for the symptomatic relief from, and management of, chronic intractable pain and post-surgical and post-trauma acute pain. Pain messages transmitted by the peripheral nervous system to the brain are elecro-chemical in nature. Traditional TENS therapy delivers electrical energy using a constant sine or square wave form. TENS is a method of applying low-voltage electrical current through the skin at various placement sites using surface electrodes. The peripheral stimulation induces electrical activity which inhibits the brain’s perception of pain. The gate control theory is based on the principle that there is a gateway in the dorsal horn of the spinal cord, which somehow controls or regulates the flow of pain messages that are then sent to (ascending) and from (descending) higher levels of the brain for central processing, thus reducing the perception of pain. Additional postulated mechanisms of pain relief mediated by TENS include the promotion of endorphin release in the brain and local dilation of blood vessels in injured tissue.

The Tennant BioModulatorTM is a precision medical instrument indicated in the use for symptomatic relief and management of chronic, intractable pain. The BioModulatorTM is a biofeedback-like device that uses a sophisticated computer controlled, feedback modulated, electro-stimulus applied through the skin to the cutaneous (surface) and afferent (deep) nerves to diminish symptoms of pain. The device was first developed in the 1970s for the Russian Space program and is currently used in Europe as a popular alternative to pharmacological control of pain. Mechanisms of pain relief mediated by the BioModulatorTM
are thought to be similar to that of TENS and acupuncture where electrical stimulation helps to reduce nerve blockages and helps to promote the release of endorphins in the brain. The BioModulatorTM is a type of very low frequency TENS known as pulsed electromagnetic field therapy (PEMF). Unlike TENS devices that deliver 1-80 milliamperes of electrical current, PEMF devices deliver short bursts of electrical microamperes (millionths of an ampere) to injured tissues without producing heat or interfering with nerve or muscle function. The PEMF waveform affects ion/ligand binding at cellular surfaces and modulates a cascade of biochemical effects that promotes soft-tissue healing through increased Adenosine Triphosphate (ATP) production in the underlying tissues, increased amino acid transport into the cell, and improved cellular removal of waste products.

Traditional Chinese Acupuncture has been claimed as an effective treatment for chronic pain for centuries in other cultures. It has a very similar functional background to TENS. Acupuncture excites receptors or nerve fibers which, through a complicated interaction with serotonin and endorphins, blocks pain impulses. Acupuncture as a therapeutic intervention has a history that is over 2,500 years old in China and Japan. The diagnosis and treatment prescribed by traditional Chinese medicine is influenced by the systems of medicine and philosophy of ancient China. According to traditional Chinese medicine an imbalance in the Yin and Yang forces of the body presents as pain or disease. Acupuncture treats illness by recreating the balance between these forces within the body by promoting the flow of Qi (life force energy) along main meridians or channels which enables balance for the human body system. Acupuncture involves the insertion of fine needles into the skin and underlying tissues at precise points on the body.

This work is supported by the US Army Medical Research and Materiel Command under Award Numbers:


The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation.

In the conduct of research where humans are the subjects, the investigator(s) adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects).