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PHYSICAL DISORDERS

PAIN

6. Clark, Morris S., Silverstone, Lwon, M., Lindenmuth, James et al. An evaluation of the clinical analgesia/anesthesia efficacy on acute pain using the high frequency neural modulator in various dental settings. Oral Surgery, Oral Medicine, Oral Pathology. 63(4):501-505, 1987

Device: high frequency neural modulator, 15 Hz, 4 mA, temporal electrodes, and introral to

hand electrodes

50 healthy, nonpregnant dental pts from 16 to 60 years old were separated into an experimental group (N=30), and placebo group (N=20) in this double-blind study to evaluate the effectiveness of CES and peripheral stimulation as a substitute for local anesthesia in various dental procedures, including oral surgery, restorations, tooth extractions, root planing, pulp extirpation, and temporomandibular joint therapy. The degree of pt comfort and satisfaction, their request for local anesthetics, as well as manageability of pain control by the dentist was evaluated. In the experimental group, favorable responses ranged from 0.0% to 92.8%, depending on the procedures. 24 of 30 (80%) CES pts were able to undergo dental procedures without anesthesia. 15 of 20 (75%) of the placebo group required anesthesia. In the operative group, 13 of 14 pts were treated successfully with CES, whereas only 3 of 7 placebo CES pts did well, which is significant at the 0.05 level. All 3 of the CES pts and all 3 placebo CES pts required anesthesia for endodontic procedures. An overall favorable rating of 71.8% was given by the experimental group, whereas an overall favorable response of 8.5% was given by the placebo group. Pts gave favorable comments and all stated that this procedure would be their first choice in future visits. No side effects were reported.

22. Hochman, Richard. Neurotransmitter modulation (TENS) for control of dental operative pain. Journal of the American Dental Association. 116:208-212, 1988.

Device: Neurotransmitter Modulator, electrodes across temples

This is an unblind study of 600 dental procedures over a 1 year period. Although the author refers to the device as a TENS, electrodes were placed across the temples for 10 minutes prior to each procedure which makes the treatment CES by definition. The procedures ranged from vigorous subgingival scaling to endodontic. Results were evaluated for pain control related to procedure type, and the patients' skepticism about the procedure. Results were considered positive if the patient reported greater than 90% reduction in pain and did not request the additional administration of local anesthetic. More than 76% of the pts in all procedures reported 90% or greater success using CES for dental analgesia. For the 71 scaling and prophylactic procedures, more than 83% reported successful pain reduction, and for the 473 restorative procedures, more than 76% reported pain reduction success. For 29 crown preparations, "only" 55% reported success. The majority of pts were skeptical about the procedure but after experiencing CES they were more comfortable with CES than they were with previous dental experiences. The author concluded that from the results obtained during 1 year of treating a variety of pts requiring a broad scope of dental treatments, CES was found to provide a safe, noninvasive, readily acceptable, adjunctive analgesic modality to maintain pt comfort through the majority of dental procedures for most pts. Additional, unexpected positive results were found when the pts reported "feeling more relaxed than usual." No side effects were reported.

54. Shealy, C.N., Cady, R.K., Wilkie, R.G., Cox, R, Liss, S, and Clossen, W. Depression; a diagnostic, neurochemical profile & therapy with cranial electrical stimulation (CES). Journal of Neurological and Orthopaedic Medicine and Surgery. 10(4):319321, 1989.

Device: Liss Pain Suppressor

14 non-smoking adults (6 males, 8 females, 22 - 72 years old) with no known illness served as Group 1 controls. Group 2 were 14 intractable chronic pain pts (5 males, 9 females, 30 - 68 years old). Group 3 were 9 chronic pain pts considered by themselves to be hopeless (3 males, 6 females, 32 - 60 years old). Group 4 were 11 pts with longstanding depression of more than 2 years unresponsive to 2 or more antidepressant drugs (3 males, 8 females, 30 - 67 years old). Fasting blood levels of serotonin, -endorphin, norepinephrine, and cholinesterase were taken, along with the Zung test for depression, before and 2 weeks after CES, given for 20 minutes each day. In the depressed patients there was a significant elevation of serotonin (mean of 33.18 9.33 pretest to 44.64 9.10 post test P<.0089) and a significant decrease in cholinesterase (mean of 13.82 2.86 pretest to 10.45 3.04 post test P<.0067). There was a clinical lifting of depression in 60% of depressed pts and an improvement in pain complaints in 44% of the pain pts. The authors concluded that CES may be of therapeutic value in depression and in chronic pain. 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.

77. Wilson, L.F. and Childs, A. Cranial electrotherapy stimulation for attentiontotask deficit: A case study. American Journal of Electromedicine. 5(6):9399, 1988.

Device: RelaxPak, 100 Hz, 2 mS, 1 mA, sine wave, bilateral electrodes

4 pts with measurable attentiontotask deficit were studied. 2 had severe pain problems (27 year old female and 30 year old male) but no brain injury, while 2 had suffered from post brain trauma (29 year old male, 25 year old female). One of the pain pts served as placebo control (the 30 year old male) for the other 3, each of whom served as his or her own control. CES was given for 50 minutes per day, 5 days a week for 3 weeks. Pts were pre- and post-tested on standardized cognitive measures (Trail Making Test, Digit Symbol Test, Porteus Mazes, Consonant Trigrams Test, Rey Auditory-Verbal Learning Test, Paced Serial Arithmetic Test) before and following CES, and again 3 weeks later. Pts were also tested on the Profile of Mood States Inventory. The results among the CES treated pts showed striking and significant improvement in the post treatment scores and in the associated extent of the neurological deficit. It was concluded that CES is an effective nondrug alternative in a cognitive rehabilitation model for treating attentiontotask deficit. No side effects were reported.

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