Diapulse & Acute SCI
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Clinical Trials of the Application of Pulsating Electromagnetic Energy (Diapulse) in the Treatment of Spinal Cord Lesions

Jerzy Kiwerski & Teresa Chrostowska, Rehabilitation Clinic, Medical Academy, Warsaw/Konstancini/; Director, Professor M Weiss, MD

 (from: Chir. Narz. Ortop, Pot 1980. Vol 45, no. 3, pp. 273-277)

Ninety-seven patients underwent treatment. The results of the treatment are discussed.

Paralysis of muscle groups after injuries to the spinal cord may result from mechanical destruction of gray matter or spinal cord tracts. More frequently, however, the decisive factors are disruptions of blood perfusion, vascular spasms, with the ischemic changes aggravating the post-traumatic hematoma or the dynamically increasing spinal edema that extends to the adjacent areas as well as the injured segment.

Medical treatment cannot counteract irreversible changes caused by the mechanical damage; our efforts are directed at preventing the origination and spread of secondary alterations, primarily vascular effect, and reducing to a minimum the duration of spinal edema, because the growth, or longer duration of the edema, leads to irreversible changes in the structure of the spinal cord In this context it seemed justified to undertake clinical trials, in the early post-traumatic period, of the Diapulse technique, which affects three important processes in the post-traumatic states: 1) reduction of edema and pain, 2) promotion of hematoma absorption, and 3) increase of the blood perfusion.

The electromagnetic field, acting on the tissues damaged by the injury, assists the processes of repolarization of the damaged cells, leads to the proper distribution of electric potentials on the cell membranes, and thus to their proper conductivity. Our experiments on an animal model, as well as clinical experience, seem to support thus far these theoretical assumptions. There is an undoubted effect of a high-frequency electromagnetic field that reduces edema (1, 9, 15), improves peripheral circulation (3, 5, 6, 10), hematoma absorption (2, 4, 15), and even enhances regeneration processes in the nervous system (1, 13, 14).

 

TECHNICAL DATA AND APPLICATION TECHNIQUE OF ELECTROMAGNETIC FIELD (EMF).

In our clinical studies, we used the D 104-A model of the Diapulse Corporation of America The device generates an electromagnetic field of high frequency energy (27.12 megahertz 0.005 MHz). Energy waves of a duration of65 microseconds are formed with a controlled frequency of 80 to 600 per second, creating a mean power of 1.52 to 38 watts (peak power, 25 1-975 W).

Two or three times daily, we applied in the vicinity of the injury the frequency of 600 Hz, at maximum penetration depth 6, for 20 minutes per session. Once daily, the Diapulse was applied in the area of the liver and the left adrenal, with the frequency 400 Hz and penetration depth 4. Session duration was 15 minutes. The course of treatment was continued for 10 to 30 days post-trauma, with the average of 16 days.

CLINICAL MATERIAL

During the course of 2 years (until September of 1978), we studied 97 patients with post-traumatic lesions of the spinal cord. The group included patients admitted to the Warsaw Rehabilitation Clinic within 24 hours post-injury, mainly with a total or substantial injury of the spinal cord. Table I gives the patients' age and the degree of lesion of the vertebral column. As seen from the table, most patients were individuals of a productive age (over 78%), which can be linked to the highest frequency of spinal cord injuries in this age interval. The most frequent localization of lesions was the lower cervical segment (over 45% of the group studied) or the lower thoracic segment (24%).

Table 1
Level of vertebral column injury

 

Patient Age C-1 C4 C-5 C7 D-1 D-5 D-6 D-12 L-1 L-3 Total
Under 20 1 1 2 4 1 9
21 40 3 18 3 11 6 41
41 60 3 18 1 7 6 35
Over 60- 3 7 1 1 - 12
Total 10 44 7 23 13 97

Table II gives the degree of lesion of the spinal cord correlated with the level of the lesion along the vertebral column. The evaluation of partial spinal cord lesion was made using a three-grade classification (7): 1) complete paralysis from the level of the lesion with traces of deep sensibility retained in the feet, 2) deep paresis with retention of traces of functionally ineffective motor activity, and 3) paresis impairing the function of the extremities.

TABLE II
Level of vertebral column injury

Degree of Lesion

 

C-1 to C-4 C-5 to C-7 D-1 to D-5 D-6 to D12 L-1 to L-3 Total
Complete

 

1 26 6 18 6 57
Partial 1 3 13 1 4 4 25
Partial 2 5 5 - 1 2 13
Partial 3 1 - - - 1 2

Patients had complete paralysis (about 60%), or motor incapacity with retention of traces of deep sensibility (with the subgroup i of partial paresis accounting for 25%). These are situations that, with routine treatments, rarely lead to a marked neurological recovery.

The results of treatment are presented in Table III, which indicates the change of the neurological status as referred to the level of injury on the vertebral column.

TABLE III
Level Of Vertebral Column Injury

 

Change in Status C1 C4 C5 C7 D1 D2 D6 - D12 L1 L3 Total
Improvement C-1 - 1 - - - 1
Improvement C-2 - 1 - 1 - 2
Improvement 1-2 1 2 - 2 2 7
Improvement 1-3 2 11 1 2 1 18
Improvement 2-3 3 3 - 1 2 9
Improvement 3-n 1 - - - - 1
No Improvement C-C - 18 6 16 6 46
No Improvement 2-2 1 1 - - - 2
No Improvement 3-3 - - - - 1 1
Death

 

2 7 - 1 - 10

A pronounced neurological recovery was observed in 38 patients, i.e., some 40% of the group under study. Remarkably, in 28 individuals the recovery had substantial functional value: the patients were discharged from the Neuro-orthopedic Department with paresis slightly impairing the function of the extremities. It is noteworthy that all patients who presented paralysis of extremities with traces of deep sensibility at the time of admission experienced a marked neurological recovery. Ten patients died due to complications (mostly of the respiratory system) in the early post-traumatic period. Eight of these had complete spinal cord injury in the cervical segment

DISCUSSION

The results of treatment of the group of patients with a serious injury to the spinal cord included in the study can be described as positive. In patients with such neurological lesions observed at the time of admission, one rarely attains a definitive neurological improvement. In this group, it was obtained in 40% of cases.

Is it possible on this basis to conclude with certainty that EMF had a positive effect on the damaged spinal cord? We do not think so, because: 1) The group under study is not sufficiently homogeneous to warrant conclusions of such importance based on our experience; 2) in clinical conditions we cannot limit our treatment to EMF as the only method in managing patients with spinal cord injures.

Our patients were treated simultaneously with anti-edema medications (such as mannitol and dexametazon), re-position of dislocated vertebrae by weight traction or surgical intervention (in some cases, with early relief to the spinal cord via removal of the fragments of vertebra or disk pressed into the spinal cord canal), early surgical stabilization of the vertebral column (cervical, with anterior approach (8), and thoracic and lumbar, by spring apoplasty (11). In addition, we instituted an early horizontal positioning and a complete program of therapeutic management (12).

It is therefore difficult to evaluate in clinical conditions, given the natural variety of the mechanisms of lesion and clinical pictures, which of the methods used was primarily responsible for the achieved neurological recoveries. We attempted to clarify the doubts in experimental conditions, by selecting identical or closely similar types of spinal cord lesions induced by means of precisely dosed injury. The post-injury management of the animals was confined to the Diapulse technique as the only therapeutic modality used. It seems that, as a tentative conclusion, the use of EMF to treat spinal cord lesions improved the neurological recovery compared to results obtained earlier with other methods.

We are certain that any further conclusions in this area will require increasing the number of cases of acute injury of the spinal cord observed and comparing the results with appropriate control groups.

CONCLUSIONS

1. In patients with complete or deep lesion to the spinal cord subjected to a Diapulse treatment, a marked improvement was observed in 38 individuals, i.e., some 40% of the group studied.

2. Despite the favorable treatment results, it is impossible to decide unambiguously as to the degree to which the application of EMF was responsible for the improvements, because of the diverse neurological pictures of the patients and the simultaneous administration of other treatments.

3. Experimental studies on animals have been initiated to elucidate the effects of the Diapulse on the spinal cord lesion with selection of identical types of lesion and the use of Diapulse as the only treatment modality.

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