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The Therapeutic Value of Pulsed
Electromagnetic Energy (Diapulse®)
In The Treatment of
The Post Partum Patient
A Pilot Study*

John E. Fenn, M.D., F.R.C.S.
Dept. of Obstetrics & Gynecology
St. Michaels Hospital, Toronto, Canada
The therapeutic value and the biological effects of the irradiation of the electromagnetic spectrum have been the subject of many studies since the turn of the century when in 1895 Roentgen discovered X-Rays. Progress and knowledge have been slow until the last decade when more information has become available regarding the electro chemical intracellular effects of electromagnetic energy below the level of 30 MHz: that is its ability to deposit energy within the cell and alter the intracellular electro chemical behavior. This being shown by an acceleration of the processes of cellular repair to the visible cellular changes representing physiological damage, resultant cellular death and cellular repair.

The beneficial and adverse effects of irradiation of the different levels of electromagnetic spectrum have been recognized and accepted in general by the biophysical and bio-medical professions. Until recently it was thought that the thermal factors involved produced both the beneficial and adverse effects associated with the irradiations of the electro-magnetic spectrum.

Although most of the work in the past has been concentrated on the cellular effects of X radiation, that is, the indirectly ionizing radiation, the importance of the directly ionizing radiation is assuming its role of importance in the cellular repair processes at the electrochemical and the bio-chemical level. Dale and his co-workers using carboxy peptidase showed that the reactions obtained, when the solutions were irradiated, were limited by factors present within the solution. When one considers the disassociation constant of water being subjected to an intense field of electrons radiolysis — it is readily seen the number of chemical changes possible that could take place with resultant alteration of the PH; that is, an alteration in the Redox System or hydrogen ion electron transfer process.

Many attempts have been made to eliminate the heat factor from the use of electromagnetic energy. These attempts have utilized various methods of micro energy and macro pulsations as well as the use of hypothermia and hyperthermia
All of these methods have their limitations in that the thermal factor is not completely eliminated; therefore prolonged exposure will result in cellular death.

In 1933 Ginsberg postulated that by increasing the energy wave packets and controlling the emission of these high energy quantums the physiological response could be improved. The initial responses were not as great as expected due to the equipment available at that time. It was not sophisticated enough to generate the wattage required nor was it able to produce a standard signal or an invariable wave length.

In the late nineteen thirties Milinowski and Ginsberg developed circuitry which could produce a standard signal capable of carrying these high-energy quantums for a minute period of time. The power produced was nine hundred and seventy-five watts for a period of sixty-five microseconds. The amplitude of the pulse together with the pulse width were constant, only the pulse interval and energy involved could be varied in a standard manner giving an average maximum power output of thirty-eight watts. The wave-form itself was a flat topped wave oscilloscope as compared to that of diathermy, which has a peak top wave. This variance enabled different depths of penetration together with different physiological effects such as vasodilatation and increased smooth muscle activity and accelerated wound healing.

To date due to lack of sophisticated micro electro biophysical and micro bio-chemical methods, most of these observations have remained in the nebulous field of subjectivity and since they have not been able to withstand objective scrutiny have been, heretofore, labeled questionable.

It is only now that we are able to obtain information that is objective in part. Until our laboratory methods at the intra-cellular level become more refined and our technical assistance become more specialized and more available, we as clinicians must, as the saying goes, "fly by the seat of our pants": i.e., be more tolerant to our research colleagues in offering to them our whole hearted support, cooperation and encouragement, we cannot afford to sit back and dogmatically state that because we cannot understand certain mechanisms they are false.

The technicological aspects of modem medicine have advanced so rapidly in the last two decades it is impossible for us who are limited to the clinical confines of medicine to be current in our research thinking — I am sure most of you have undergone that embarrassing situation that develops when your fourteen year old requests help in physics and mathematics or even more horrifying is a question in biometrics. With the above factors in mind I submit to you my experiences with the above-mentioned modality in the treatment of the postnatal patient.
MATERIAL AND METHOD
A pilot study was carried out on forty-seven post-natal patients who were selected consecutively, no attention being paid to age, parity, method of delivery, or obstetrician. Initially, certain parameters of clinical evaluation were established. The method of treatment was standard in that each patient would receive the initial treatment as soon as feasible following delivery, and it would consist of exposure of either the perineum, if a vaginal delivery or the abdominal wound if a Caesarian section. The settings used were a pulse frequency of six hundred per second and peak power setting of six (975 watts of peak power) for a period of ten minutes. The hepatic and the left costovertebral regions were exposed for a period often minutes each at a pulse frequency of four hundred per second and a peak power of four (585 watts of peak power). The thirty minute treatment was repeated twice daily for three days in vaginal deliveries and five days in Caesarian sections. Clinical and laboratory observations were recorded daily. These observations included amount of medication. narcotics, barbiturates and analgesics. General condition of the patient T.P.R. height of fundus and number of perineal napkins required per day, and the condition and odour of the lochia. The incision, whether it be perineal or abdominal was observed for heat. swelling. redness and induration. Laboratory investigation consisted of an initial and final Hb and smear with a daily white count routine. daily urinalysis: this was recorded on the standard information form.

Using the above parameters a trial double blind study was carried out on six patients. One standard Diapulse unit was devitalized by removing one two-ampere fuse in the output portion of the circuitry. This prevents the power from reaching the treatment head but does not interfere in any way with the operation of the machine: that is, both the indicating lights and the wattage meter register, the cooling fan operates. In other words the units outwardly behave the same. The neon tuning lights were covered with adhesive tape and the tuning knobs of both machines were taped in a fixed position. The viable unit was tuned by me every morning so that the operator did not know which machine was viable: they were marked A and B machines.

Within twenty-four hours it became obvious to the operator and the nursing supervisor which machine was viable. This pointed up future difficulties when further studies of a double blind nature are commenced.

The hospital and clinical records of one hundred and fifty-three of my own private patients of the previous year, involving three hospitals, were reviewed. The pertinent clinical and laboratory findings were recorded. The absence of chronic cervicitis was assumed to be those cases, which did not require cauterization or the administration of a triple sulfa vaginal cream at the time of the six week post delivery visit

I regret that this observation is done in hindsight however I hasten to add that had it not been for the critical observance of one of my colleagues, observing the absence of chronic cervicitis in those patients who were his responsibility and concern, we would have never realized the most important objective finding of this study.
SUMMARY
Our comparable results are recorded in the following table:
  Control Treated
Number of Cases 153 47
Ave (Average) 24 (16 –to- 17 years old) 25 (14 –to- 43 years old)
Vaginal Deliveries 144 47
1. Spontaneous 70 23
2. Low forceps 68 18
3. Mid forceps 4 6
4. Breech (assisted) 2 0

Episiotomies Control Treated
1. Mid line 82 22
2. L.M.L.Z. 1 0
3. R.M.L. 4 10
4. Lateral 0 0
Vaginal Tears & Extensions 5 8
Caesarian Section 10 6

Morbidity 12 3
1. Endometritis 10 2
2. Abcess 2 1
3. Chronic Cervicitis 128 (84%) 4 (9%)

Medication Control Treated
1. Morphine grs. 1⁄4 3 1
2. Demerol 100 mgms. 21 2
3. A.P.C. & C grs. 1⁄2 85 20
4. Numbutal grs. 1 1⁄2 130 45
5. Seconal grs. 1 1/2 43 6


A review of the nurses’ clinical notes in the control group were valueless because of the tremendous variation in the terminology used.

In the treated group the observations were made by one supervisor having fifteen years experience in obstetrical nursing and her observations suggested a marked improvement in the condition of the perineum and abdominal wound with respect to edema and redness induration.
DISCUSSION
We realized we required more objective methods for evaluation. Using the CU5 Polaroid camera together with a Bakelite Fergusson vaginal speculum, we developed a standard photographic technique, which could be used by an inexperienced photographer.

At six weeks from the time of delivery, the patient would be examined and the cervix photographed so that at the completion of the study the photographs would be assessed by an impartial panel of gynecologists as to whether or not chronic cervicitis is present The panel would be blind in that they would not know which photographs were those of the untreated or those of the treated Prior to the assessment they would be provided with a standard cervical photograph.

Since this study was presented we have carried out small animal studies on rabbits and pigs using artificially induced hematomas and wounds. These studies have been comparative in nature, using all forms of electromagnetic energy other than the X-ray irradiations and have shown that pulsed electromagnetic energy of sufficiently high peak power does accelerate the wound healing processes by as much as forty-seven per-cent for the hematomas and thirty per-cent increase in the tensile strength of wounds over a certain period of time. These studies will be published in the near future.

The purpose in presenting this paper to this meeting was the hope that interest in other centres be stimulated so that our studies may be repeated and the results confirmed
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