Return to Front Page

PHYSICAL DISORDERS

HEADACHE

4. Brotman, Philip. Low-intensity transcranial electrostimulation improves the efficacy of thermal biofeedback and quieting reflex training in the treatment of classical migraine headache. American Journal of Electromedicine. 6(5):120-123, 1989. Also doctoral dissertation, City University Los Angeles, 1986.

Device: Alpha-Stim 2000GL, 0.5 Hz, 50% duty cycle, <500 µA, biphasic rectangular waves,

ear clip electrodes

In this double blind study, 36 females, ages 18-40, suffering from classical migraine headaches (ICD-9 346.0), completed informed consent and were randomly assigned to Quieting Reflex Training (QR) and placebo CES (N = 12), QR plus actual Alpha-Stim CES (N = 12), or CES only groups (N = 12). All groups were measured for temperature changes using thermal biofeedback (TB) via finger monitors on the dominant hand, and temporalis muscle EMG. All received 8 treatments (length unspecified), plus 1, 2, and 3 month follow up sessions. Medication levels dropped dramatically from the initial session to the eighth session. T-tests were employed seperately for investigation of CES and QR. Results were calculated using the formula of frequency x intensity of headaches. The findings were that groups receiving TB and QR, either with CES (pretreatment mean of 14.42 6.26, post treatment of 4.50 5.30) or with placebo CES (pretreatment mean of 15.33 6.62, post treatment of 4.33 4.46), responded significantly better than did the TB CES group alone (pretreatment mean of 14.00 4.56, post treatment of 6.33 4.38), but that the group receiving TB, QR, and CES responded significantly better (mean of .08 0.28) than the TB, QR and placebo CES group (mean of .58 1.19) or the TB and CES group (mean of 8.67 6.60) at the 3 month follow up period. Only the CES group showed significant carry over effects in finger temperature. EMG findings of the CES groups showed a recovery to normal 15 minutes after treatment. Those groups that did not receive the CES treatment were subsequently treated with CES and they achieved headache reductions comparable to those obtained in the TB, QR, and CES group. Observations during the study suggested that CES may contribute to both a rapid rise of finger temperature during each session and to a homeostatic rise in finger temperature over time. It was suggested that this was possibly due to a hypothalamic mechanism. No subjects in CES or placebo CES groups reported side effects.

10. England, Ronald R. Treatment of migraine headache utilizing cerebral electrostimulation. Masters Thesis, North Texas State University, Denton, Texas, December, 1976.

Device: Neurotone 101, 100 Hz, 2 mS., electrodes behind each ear

18 migraine pts, 6 males and 12 females ranging from 21 to 62 years old (mean of 37.9) were solicited by newspaper ads. After giving informed consent, The 3 groups of 6 pts each were matched on the basis of headache intensity during a 2 week baseline period and divided into CES treatment, simulated treatment, and waiting list control groups. CES was given 45 minutes per day for 15 days, Monday through Friday. A Wilcoxon matched-pairs, signed-ranks test was calculated for the difference scores for each of the variables of headache frequency, intensity, and duration. The frequency of headaches had not changed significantly by the end of the study. There was no significant difference in intensity of headaches after the second week of treatment, however, when both baseline periods were compared to the results of the third week of treatment, the CES group was found to have significantly (P< .025) lower headache intensity ratings than the placebo group. There was a significant (P<.05) reduction in duration of headache among CES pts over placebo after the second week. The waiting list control group reported improvement also, but they were asked to recall their week's experience over the telephone on Friday only, while the treatment and placebo groups were asked to keep a written record on a daily basis. It was noted that the recordings may not have been comparable and that the variable of medication usage tended to confound the results. The frequency, intensity, and duration of pain did not change in the placebo pts during or following the study. The author concluded that CES does consistently better than placebo control. 1 subject in the placebo group developed a skin irritation at the location of the electrode. She suggested that sensations felt during the treatment were responsible. No side effects from CES were reported.

43. Romano, Thomas. The usefulness of cranial electrotherapy in the management of headache in fibromyalgia patients. American Journal of Pain Management. 3(1):15-19, 1993.

Device: Pain Supressor, 12,000 to 20,000 Hz, 35µS, <4 mA, electrodes across temples

100 consecutive fibromyalgia syndrome (FS) pts (23 males ages 22 - 58, mean = 45, and 77 females ages 18 - 65, mean = 46) in a rheumatology practice with severe chronic headache unresponsive to outpatient treatments of medications (NSAIDS, beta blockers, tricyclics, and ergots), biofeedback, low tyramine diet, local injections, and physical therapy were given CES units and instructed to use them for 20 minutes, 4 times daily while continuing their medications. 75 completed the study. Dolimetry using a pressure algometer was performed at 6 active typical "tender" sites just before CES and 1 - 2 months after. Pts were also asked to rate their headache severity on a 1 - 10 scale (1 = no effect, 10 = totally effective in relieving headaches) before CES, at a subsequent visit, and at follow-up. CES proved to be effective in FS-related headache pts. Approximately 50% of FS Pts using CES regularly reported a significant decrease in the frequency and intensity of their headaches. The mean pretreatment headache intensity score was 8.1 (7.8 for males, 8.4 for females). After 1 - 2 months of CES treatment, the mean score was 4.7 (4.5 for males, 4.8 for females). The difference in the mean scores was 3.4 (3.3 for males, 3.6 for females) and there was definite subjective improvement. Dolimetric testing of 450 sites ( 6 per pt) revealed that 42% (189) were improved (had values increased > 1 kg/1.54 cm), 19% (86) were worse, and 39% (175) were unchanged. 8 pts reported absolutely no benefit, 6 stated they were entirely free of headaches, while 15 (20%) reported CES efficacy as a "7", indicating moderate improvement in both frequency and severity of headaches. 38 (51%) rated improvement as a "7" or greater. The author concluded that CES is a helpful adjunct in the treatment of FS pts with headache previously unresponsive to more conventional techniques. No side effects were reported.

66. Solomon, Seymour, Elkind, Arthur, Freitag, Fred et al. Safety and effectiveness of cranial electrotherapy in the treatment of tension headache. Headache. 29:445-450, 1989.

Device: Pain Supressor, 12,000 to 20,000 Hz, 35µS, <4 mA, electrodes across temples

112 pts were enrolled in a multicenter double-blind study of tension headaches. Inclusion criteria was that pts had to have tension headaches requiring analgesic agents for at least 1 year, and at least 4 headaches per month. Pts were excluded with diagnosis of migraine, cluster, or medication-rebound headaches, pregnant women, major physical, mental, or neurological problems, recent history of drug dependency, or implanted electrical devices. Informed consent was obtained. Pts were instructed on the use of the CES device and to treat each headaches for 20 minutes, and if necessary, again for 20 minutes, 20 minutes after the first treatment. The study lasted up to 10 weeks, but terminated after 4 headaches. Pt and physician global evaluations were the primary efficacy variables. Following use of the active unit (N = 57), patients reported an average reduction in pain intensity of approximately 35%. Placebo patients (N = 55) reported a reduction of approximately 18%. The difference was statistically significant (p = 0.01). The active unit was rated as moderately or highly effective by 40% of physicians, and by 36% of pts. Both physicians and pts scored the placebo unit moderately or highly effective for only 16%. The difference in order outcomes was statistically significant. Means of changes in headache severity of the 2 groups was 6.1 pre test to 4.0 post test for the active group (-34.4%, P<0.001), and 6.4 to 5.2 for the placebo group (-18.8%, P<0.001). 17 pts left the study early due to adverse events (2 active, 2 placebo), no effect (3 in each group), non-compliance (1 each), and 5 "others". 6 of 57 in the active group, and 7 of 55 in the placebo group had 1 or more adverse events. The incidence of adverse events was not significantly different between the active and the placebo groups for any of the reported symptoms. The authors concluded that it appears that CES is safe, and should be considered in the management of tension headaches as an alternative to the chronic usage of analgesics.

Return to Front Page