Cranial Electrotherapy Stimulation: Treatment of Pain and Headache in Military Population
Kirsch, D.L., Marksberry, J.A., Price, L.R., Nichols, F.H., & Platoni, K.T. Cranial Electrotherapy Stimulation: Treatment of Pain and Headache in Military Population. Practical Pain Management. 2011; 15(8).
Funding Source, Location of Study or Author’s Affiliation
Electromedical Products International, Inc., Mineral Wells, Texas.
Understand the safety and effectiveness of cranial electrotherapy stimulation (CES) for the management of pain.
A survey of Service Members and Veterans Survey was conducted as part of a post-marketing surveillance survey for the Food and Drug Administration (FDA). Patients were selected from the Department of Defense (DoD) and Veterans Affairs Medical Center (VAMC) prescription information database. Participation was voluntary.
Primary Outcome Measure
The survey assessed Service Members and Veterans symptoms of:
- Post-Traumatic Stress Disorder (PTSD)
Symptoms assessment was made at baseline and post CES treatment using 7-point Likert scale to rate change following CES:
- Worse (negative change).
- No change (0%).
- Slight improvement (1% to 24%).
- Fair improvement (25 to 49%).
- Moderate improvement (50% to 74%).
- Marked improvement (75% to 99%).
- Complete recovery (100%).
Secondary Outcome Measure
The survey included questions about Service Members and Veterans:
- Background and demographics.
- Prescription medication.
- General safety of CES treatment.
Key Inclusion Criteria
- Service Members and Veterans.
- History of pain.
- Prior use of CES device.
Key Exclusion Criteria
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. The devices were locked at the designated levels for each specific group for current level and time by the manufacturer at the factory and sham devices.
Device Application 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.
Statistical Analysis Plan
Prior to statistical analyses, the data were screened for missing and out-of-range values. The survey responses were analyzed using descriptive statistics.
The Dworkin and colleagues’ criteria for determining improvement of clinical importance was used to assess clinical significance. Improvement of substantial clinical importance (≥ 50%) was considered substantial clinical improvement, and improvement of moderate clinical importance (25%-49%) was termed moderate clinical improvement. The primary benefit of using the Dworkin criteria is that, in addition to the “gold standard” of a group that improved by at least 50%, an improvement of 30%-49% is categorized as a gain of moderate clinical importance. In a severely injured population, even a lesser amount of improvement than the established standard of at least 50% has the potential to improve pain and headache outcomes.
A sample of 143 Service Members and Veterans with symptoms of pain and concurrent headaches. Safety and effectiveness were taken from previous surveys of CES users that included 5,171 civilian participants. Of the 1,514 persons invited to participate in the survey, 152 submitted the on-line questionnaire, yielding a response rate of 10%. The majority of participants were male active-duty service members (72%). The mean age was 38 years (standard deviation±10).
At the time of the survey, 82% of participants were still using CES. The mean length of time using the device was 12.1 months (range, 3-36 months). Fifty percent of participants reported using CES once per day while 24% reported using CES twice daily, and 7% reported using the treatment at least 3 times per day. Eighty-two percent (82%) of participants who responded to the question about pain were taking pain medications. Of those participants who responded to the question about headaches, 75% were taking anti-migraine medication, pain medication, or both.
- In total of a sample of patients with pain (N=73) 30% reported decreased pain and clinical improvement of ≥ 50% while 15.1% reported clinical improvement between 25-49%. A total of 45.1% of all group participants using CES reported ≥ 25% clinical improvement.
- In the CES only group (i.e., no medications), 61.6 % of respondents reported decreased pain and clinical improvement ≥ 25% (46.2% ≥ 50%, 15.4% between 25-49% improvement) while 41.7% of the CES and medications group reported decrease pain and clinical improvement ≥ 25% (26.74% ≥ 50%, 15 % between 25-49% improvement.
- In a sample of patients (N=70) with a history of recurrent headaches 40% reported decreased pain and clinical improvement of ≥ 50% while 18.6% reported clinical improvement between 25-49%. Of the total group, 58.6% of participants reported ≥ 25% clinical improvement.
- The CES only group (i.e., no medications), 100% of respondents reported decreased pain and clinical improvement ≥ 25% (64.7% ≥ 50%, 35.3% between 25-49% improvement) while 45.3% of the CES and medications group reported decrease pain and clinical improvement ≥ 25% (32.1% ≥ 50% pain relief and 13.2 % reported between 25-49% improvement.
- On the 7-point Likert CES Clinical Improvement scale, the moderate (50%-74%), marked (75%-99%), and complete improvement (100%) categories were collapsed into a single category defined as substantial clinical improvement of at least 50%. The fair improvement category (25%-49%) was designated moderate clinical improvement.
There was a marked difference between the CES-only and CES plus medication groups. Participants in the CES-only group consistently rated their improvement from using the device higher for both pain and headache. For example, 100% of participants in the CES-only group reported either substantial or moderate clinical improvement for headache.
The study concluded that subjects in the CES-only (no medication) group consistently reported higher pain relief from CES than those individuals in the group that received CES and medication.
The results are based on self-reported data and may have been affected by recall bias. The response rate was lower than usual for a Web-based survey and participants may not be representative of the total group of service members and veterans who used CES. Finally, findings from this type of study cannot be generalized or used to infer causation. However, they do provide important information and insights not before available.
Study Quality: FAIR