Cranial Electrotherapy Stimulation: Treatment of Pain and Headache in Military Population
A critical aspect of treatment for virtually every trauma-related battlefield injury is the management of pain.1-4 An increasing amount of research indicates that persistent pain can change brain circuitry, including the brain’s endogenous mechanisms for controlling pain, and make it more difficult to control pain as it becomes chronic (lasting >3 months).5
More acutely, survival rates among combat soldiers are greater today than in previous wars as a result of improvements in battlefield medicine.2,6 However, the physical injuries are more severe than in the past, making modern soldiers more difficult to treat.2,7
Typically, battlefield injuries affect multiple organ systems and involve blast injuries from improvised explosive devices and roadside bombs, which often result in traumatic brain injury (TBI), the signature injury of Operation Enduring Freedom in Afghanistan and Operation Iraqi Freedom.8
The most common major physical injuries suffered by service members who served in the Afghanistan and Iraqi theaters of operations were complex musculoskeletal limb deformities, major extremity amputations, and TBIs.8,9
Chronic pain and headaches are a common problem following a combat injury, especially a TBI.10 In a 3-year study of veterans, approximately 10% were diagnosed with TBI, 30% with post-traumatic stress disorder (PTSD), and 40% with pain. Approximately 6% of veterans had all 3 diagnoses, also known as the polytrauma triad.11
In a review of 12 studies that included 1,670 patients, Theeler and Erickson reported that that 58% of patients with TBI of any severity experienced chronic headaches.12 In US service members, after a concussion the incidence of acute post-traumatic headache (PTHA) ranged from 31% to 96%. PTHA persists in 32% to 78% of patients at 2 to 3 months, 8% to 35% at 1 year; and approximately 20% at 3 to 4 years.12
The US Department of Veterans Affairs defines the term polytrauma as the condition of injuries to multiple body parts and organ systems that often, but not always, result from exposure to a blast.13 The combined course of pain following polytrauma from the time of injury to 12 months is shown in Figure 1. Although the incidence of most types of pain decreased over time, pain from blast-related headache continued to increase for up to 6 months after injury, remained high, and decreased only slightly by 12 months, resulting in significant morbidity.14
The Department of Defense (DoD) and Veterans Affairs Medical Center (VAMC) providers prescribe cranial electrotherapy stimulation (CES) for the treatment of pain and headaches. Reports from clinical observations of DoD and VAMC practitioners on the effectiveness of CES for pain and headache are consistently positive. However, a search of the literature revealed no research about how service members and veterans perceived the effectiveness of CES for the treatment of pain and headache. The purpose of this study was to address this gap in the literature and to explore perceptions of the safety and effectiveness of CES for pain and headache in this population of patients.
The CES Device
In this study, the Alpha-Stim CES device (0.5 Hz, 100-600 µA, 50% duty cycle, biphasic asymmetrical rectangular waves) was used. About the size of a smartphone, the stimulator sends a mild electrical current to the brain using ear clip electrodes. CES, a noninvasive brain stimulation modality,15 is cleared by the Food and Drug Administration (FDA) for the treatment of anxiety, insomnia, and depression. Clinical observations revealed that CES also reduced pain and headache.
Four clinical trials that examined the effect of CES on pain found that the therapy significantly decreased pain.16-19 Based on research from functional magnetic resonance imaging, EEG, and clinical neurotransmitter studies, the treatment mechanisms of CES include:
- Deactivating brain regions associated with hyperactivity consistent with various disorders, such as pain, anxiety, insomnia, depression, and sleep problems.
- Increasing alpha-wave activity that induces relaxation and a pleasant state of well-being; decreasing delta-wave activity, which increases attention and alertness; and decreases beta activity, which decreases compulsive, ruminative thoughts.
- Increasing the concentration of neurochemicals such as beta-endorphin, serotonin, and melatonin, and decreasing cortisol in the brain, which reduces pain, insomnia, and the response to stress, while improving mood.20
All participants in this survey received an Alpha-Stim CES device prescribed by either a DoD or VAMC medical provider. Each individual was instructed in how to use the stimulator at home following a DoD or VAMC protocol. Patients were told to perform CES for 20 to 60 minutes daily, with the current adjusted to a comfortable level. They could administer additional CES treatments as needed to control pain and headaches. Observations in clinical practice show that extended use of CES is well tolerated. No side-effects from prolonged use have been reported.
Data for this article were taken from the Alpha-Stim Service Members and Veterans Survey on the safety and effectiveness of CES.21 The study was conducted by Electromedical Products International, Inc., as an Alpha-Stim CES post-marketing surveillance survey for the FDA.
The data from the survey revealed that the majority of participants reported CES was effective (≥25% improvement) for the treatment of anxiety (66.7%), insomnia (65.2%), PTSD (62.5%), and depression (54%). The majority of these individuals reported at least a 50% improvement in each outcome. This article includes results from the data for pain and headache from the Alpha-Stim Service Members and Veterans CES Survey.
The survey included questions about demographic and background information; use of prescription medication; improvement from using CES for anxiety; PTSD; insomnia; depression; pain; headaches; and safety of the treatment.
Questions about safety and effectiveness were taken from previous surveys of CES users that included 5,171 civilian participants. The questions had content validity and established utility for this population. The 7-point Likert scale included the following answer options to questions that asked participants to rate their improvement from using CES: A, Worse (negative change); B, No change (0%); C, Slight improvement (1% to 24%); D, Fair improvement (25 to 49%); E, Moderate improvement (50% to 74%); F, Marked improvement (75% to 99%); and G, Complete recovery (100%).