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Soft Tissue Injuries

Treatment of Soft-tissue Injuries
by Pulsed Electrical Energy (Diapulse)
D.H. WILSON, F.R.C.S., Consultant Surgeon
Accident and Emergency Department, General Infirmary, Leeds 1
British Medical Journal, 1972, 2, 269—270
Pulsed Electrical Energy
A 975-watt emission for 65 microseconds at 2712 megacycles with a resting interval between successive pulses of 1,600 microseconds. Patients received continuous treatment for one hour and were treated daily for three days. After each treatment crepe bandages were applied from the toes to the calf and the patients were given walking instruction and exercises by an experienced physiotherapist.
Summary
Twenty pairs of patients matched for sex, age, weight, and degree of trauma were treated either with an active Diapulse machine emitting pulsed, high-frequency electrical energy or with a non-active placebo machine. They were examined for swelling, pain, and disability before treatment and after three days under double-blind conditions. The results show that the pulsed, high-frequency electrical treatment has a definite biological effect on recently injured soft tissues, especially in the reduction of pain and disability.
Introduction
The interrelation of mechanical stress and electrical charges in collagen fibers has been examined in vitro in both tendon and bone (Fukada and Yasuda, 1957, 1964; Bassett and Becker, 1962; Bassett, 1965; Shamos and Levine, 1967) and attempts have been made to use electrical energy to stimulate the repair of collagen fibers in vivo (Ginsberg, 1961). Recently J. M. Fitton and S. Hulman (personal communication, 1971) reported favorably on a subjective trial of pulsed, high-frequency electrical energy in the treatment of soft-tissue injuries. In view of this a double-blind trial was planned to make a statistical assessment of this treatment in patients suffering from a recent sprain of the lateral ligaments of the ankle joint.
Patients and Method
Patients who had sustained an inversion injury of the ankle during the preceding 36 hours were examined physically and radiologically to exclude a bony injury or a ligamentous instability of the ankle. They were then graded for swelling, pain, and disability and paired for age, weight, sex, and degree of injury.

Diapulse machines were used to give the patients pulsed, high-frequency electromagnetic radiation. These machines give
DETAILS OF DOUBLE-BLIND TRIAL
Six Diapulse machines were used, designated by random letters from the alphabet and arranged in three pairs. A fuse was removed from one of each pair of machines so as to have one functional and one placebo machine in each pair. The code indicating which machines were functional was placed in a sealed envelope by the electrician and it was not opened until, the trial had been completed. Patients receiving treatment from a Diapulse machine are not aware of any sensation as there is no heating of the tissues. Thus neither the patients nor the clinician who examined them knew which patients had received electrical treatment and which had the placebo.
GRADING OF PATIENTS’ SIGNS AND SYMPTOMS
Patients were examined before treatment on the first day and after treatment on the third day, and on each occasion were graded on a 0-4 scale for swelling, pain, and disability (Table 1).

TABLE 1
Numerical, Grading of Signs and Symptoms
Signs Grade Symptom
Swelling 0
1
2
3
4
No increase of ankle circumference compared
with uninjured ankle
Increased circumference of 0-1/2 in (1- 3 cm)
Increased circumference of -l in (13-25 cm)
Increased circumference of 1-11 in (25-38 cm)Increased circumference of over I in (38 cm)
Pain 0
1
2
3
4
No pain
Pain only after walking some distance
Pain on taking even one step
Pain when at rest on couch
Pain severe enough to require analgesics
Disability 0
1
2
3
4
No disability
Walks with slight limp
Walks with considerable difficulty
Can walk only with help of supporting arm
Cannot walk at all

ResultsThe scores of the 20 placebo patients (Table II) and the 20 treated patients (Table III) in each of the measured categories of swelling, pain, and disability were added together. In each category the percentage improvement in the treated patients was about twice that of the placebo patients.

TABLE II - Total Grades of 20 Placebo Patients
  Swelling Pain Disability Total
Before treatment
first day
38 37 41 116
After treatment
third day
26 25 23 74
Percentage improvement 31.6 74.4 75.6 756


TABLE III - Total Grades of 20 Treated Patients
  Swelling Pain Disability Total
Before treatment
first day
38 43 46 127
After treatment
third day
14 11 6 31
Percentage improvement 63.2 74.4 86.9 75.6
STATISTICAL ANALYSIS
With a non-sequential method of analysis the Diapulse treatment was found to be significantly preferable to the placebo treatment on all four counts - that is, swelling, disability, pain, and total scores.

A Bross plan B chart for sequential analysis of matched pairs was used and Diapulse was found to be a preferable treatment compared with placebo, statistically speaking, with respect of improvement in disability scores, pain scores, and total scores. No significant difference between the two groups was found as regards improvement in swelling scores, although the trend of results seen looked likely to produce a significant result, given more results.
The outcome of awarding a positive sign when the treated patient’s progress was better than his or her matched pair and a

TABLE IV - Results of Treatment in 20 Matched Pairs of Patients
  # Positive # Negative P Value
Swelling 9 2 .033
Disability 12 2 .006
Pain 13 2 .002
Total Scores 13 2 .011

negative sign when the placebo patient made more progress is shown in Table IV. No sign was awarded when there was no clear preference between the two patients. The P values in all four categories are less than 0~O5.
Discussion
This investigation shows that so far as sprained ankles are concerned pulsed, high-frequency electrical treatment has a biological effect on recently-injured soft tissues. This is particularly noticeable in the reduction of pain and also disability. The treatment is time consuming, however, both for the patient and for the physiotherapist and it is probably not justified in treating minor sprains where the patient can walk on the ankle after the application of an adhesive bandage, but for the patient who is more severely injured it has been shown to be a valuable method of treatment.

I wish to express my thanks to the Principal and Governors of Nonington College of Physical Education for making available the services of Miss V. Barclay, who gave die physiotherapy treatment.

The Diapulse machines were loaned by the Diapulse Corporation of America.

The statistical analysis of the results was prepared through the good offices of Messrs. Smith & Nephew Limited.

References
Bassett, C. A. L. (1965). Scientific American, 213, 18.

Bassett, C. A. L., and Becker, R.O. (1962). Science, 137, 1063.

Fukada, E., and Yasuda, I. (1957). Journal of the Physiological Society of Japan, 12,1158.

Fukada, E., and Yasuda, I. (1964). Japanese Journal of Applied Physics, 3, 117.

Ginsberg, A. J. (1961). International Record of Medicine, 174, 71.

Shamos, M. H., and Levine, L. 5. (1967). Nature, 213, 267.
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