Editor's Memo: Interpreting Indications For Electromagnetic Therapy
Most pain practitioners are very familiar with pain therapies that utilize an electric current. Today, the best-known treatments are transcutaneous electrical nerve stimulators (TENS), implanted electrical stimulators, and the new microelectrical currents. An electric current is a stream of electrons and protons. Electromagnetic energy surrounds an electric current. This energy field is 50% electronic and 50% magnetic. The energy field is comprised of waves of different lengths. They range from submolecular in size (example: laser) to as long as a building (example: radio). At this time, four electromagnetic energy fields or waves are being used in pain treatment:
Laser and radio energy waves at high frequency are currently being used for ablation procedures. At low frequency, these same energy waves are used for the treatment of localized, peripheral pain sites. An exciting aspect of the electromagnetic devices is that the electronic component provides pretty much the same acute, pain-relieving effects as an electric current or acupuncture. In addition, the magnetic component promotes tissue healing and has the capability of permanently reducing a patients pain. It is our recommendation that all pain practitioners familiarize themselves with the new electromagnetic devices and their applications in pain management.
This editor was recently asked to help organize a consensus committee to interpret the FDA label and indication for radio wave devices and some other electromagnetic devices. The original label and indication was given more than 30 years ago. It stated simply: "postoperative pain and edema." I was asked to assemble a small group of pain specialists who are familiar with these technologies to reinterpret the label and indication based on todays understanding of pain. The consensus statement that came out of this effort is designed to help all companies, pain practitioners, and the FDA reinterpret the label that is applied to some of the electromagnetic devices. Anyone reading our consensus statement is encouraged to comment.
I asked our Editorial Board member and long-time consultant on electromedicine, Dr. Tiziano Marovino, to not only review the consensus statement, but also provide some insight into the labeling of electromagnetic devices. His reply is fascinating: "I think the consensus statement is fine. I agree that the label for ‘postoperative pain is antiquated and non-descriptive given what we know today. I think it came from older electroanalgesia studies that examined the use of TENS on women having undergone either pelvic surgeries and/or postpartum soreness after giving birth [if memory serves me]. In any case, I agree with your position."
—Forest Tennant, MD, DrPH
Editor in Chief
A Consensus Statement: Operation, Postoperative Pain, And Postoperative Timeframe for Electromagnetic Devices
Public Health Need
There is an incalculable public need to manage and ameliorate acute and chronic pain. As modern-day pain treatment has emerged in the past decade, the public demands more effective therapies with minimal risk to control their pain. Operative procedures and their integration into modern-day pain management strategies have dramatically changed in recent years, and interpretations of therapy indications must change as well. This document serves to clarify the way we define “operation,” “postoperative pain,” and the “postoperative timeframe” in terms of today’s modern pain management. Use of clear terminology will help ensure that our patients have access to important pain relief therapies.
Many therapeutic devices that utilize electric currents or electromagnetic energy derived from an electric current (eg, laser, infrared, light, radio wave) clearly have been shown to have regenerative and therapeutic properties as well as symptomatic relief. Consequently, these devices are increasingly used in pain management. Some, however, carry a label or indication for use as a postoperative treatment for pain and edema. This labeling was implemented many years ago prior to an understanding of centralized pain, persistent pain, and inflammatory pain sites.
New Changes and Information That Bear on This Issue
An operation today seldom meets the image of a large skin incision with sutures. Tissue repair and removal are likely to be done through small skin punctures and using small scopes, needles, or cannulas. Examples are angioplasty, cardiac ablation, and ovarian cyst aspiration. Tissue repair or removal may also be accomplished by injection of a therapeutic agent, or chemical and surgical debridement.
Pain following an injury, including an operative procedure, may cause glial cells in the central nervous system to generate an inflammatory response followed by neuroplasticity (reformation) and retention of memory of pain. This pain may be permanent, as there is no known cure for centralized pain. Accordingly, aggressive postoperative pain management may be required for prevention of this condition.
A peripheral pain site contains an inflammatory soup consisting of pro-inflammatory cytokines that mediate systemic inflammatory response and may induce hypernociception, neuronal excitability, and persistent pathological pain states. The inflammatory response involves immune cells, fibroblasts, and other cells in tissue regeneration and proliferation; injured or necrotic tissues; and waste products associated with cellular injury and degradation. Therapeutic and palliative measures require that the peripheral pain site be cleared of chronic or excessive inflammation to promote healing and symptom resolution.
An operative procedure done to cure, prevent, or reduce pain ought not be regarded as a “singular event” in a continuum of pain care, which may last a lifetime and likely require multiple therapeutic modalities.
Consensus Definitions for Contemporary Pain Management
- Operation: An intervention that involves use of an instrument, penetrates the skin, and is intended to remove or repair diseased, damaged, or unwanted tissue.
- Postoperative Pain: Pain within close proximity to the operative site, which may or may not be causally related to the operation.
- Postoperative timeframe: Indefinite as long as pain remains at the operative site.
Forest Tennant, MD, DrPH
Veract Intractable Pain Clinic
West Covina, California
Nancy Sajben, MD
La Jolla, California
James Mack, PhD
GV Montgomery VA Hospital
Robert S. Stall, MD
Bay Pines VA Hospital
Bay Pines, Florida