The Efficacy of the Drionic Device in the Treatment of Hyperhidrosis in Juvenile Amputees

K. TEDFORD, J. R. ENGSBERG, S. FELLOWES, R. BALLANCE, AND J. A. HARDER


Introduction

Most juvenile amputees who wear one or more artificial limbs have problems with excess perspiration (hyperhidrosis) of the stump inside the prosthetic socket. It appears to be the most common reason for the removal of the prosthesis prior to the end of the day. Perspiration build-up can result in various skin disorders which can cause a disruption in the daily wearing pattern of the prosthesis. The amount of perspiration varies from child to child and also appears to be related to several factors: (1) limb surface area involved, (2) socket design, (3) socket material, (4) wearing time, (5) child's activity level, and (6) season of the year. Thus, it is of considerable clinical interest to explore methods of reducing perspiration in order to increase wearing time.

Since 1984, a compact iontophoretic machine called the "Drionic Special Applications Device for the Amputee" has been available for the treatment of hyperhidrosis of amputees. Several studies have shown that a similar Drionic device appears to be useful in the treatment of hyperhidrosis of the axillae, palms, and soles.1-3,6,7 Literature to support the efficacy of the Drionic Unit in the treatment of hyperhidrosis in amputees, however, could not be found. The purpose of this study was to determine the efficacy of the Drionic device in alleviating hyperhidrosis in juvenile amputee patients.

Methods

Six children between the ages of eight and eighteen years volunteered to participate in this study. Three were belowelbow amputees and three were lower limb amputees (two had below-knee amputations and one child had an aboveknee amputation). Each subject wore one or more prostheses in a consistent wearing pattern and complained of sweating problems. The six children and their parents were familiarized with the Drionic Unit and procedures of the study prior to signing a hospital approved consent form.

An A-B-A design was selected. The first A (pretreatment tests) represented the absence of the Drionic treatment or baseline period, B (treatment tests) represented the daily active treatments with the machine, and the second A (posttreatment tests) was the follow-up period to determine how long the treatment effects persisted.

Sweat measurements were taken weekly at the Alberta Children's Hospital during all three phases. For the purposes of this study, quantitative readings of sweat were measured by the use of Wattman's paper 7 cm, in diameter. This filter paper is used clinically for sweat chloride testing and was weighed prior to applying it to the clean air dried stump and secured in position with a plastic bag that enclosed the entire stump. The stump area to which the Wattman's paper was applied varied for each patient but was consistently placed for each patient. The cleaned prosthetic socket was reapplied over the bag and worn for exactly thirty minutes while the child was involved in a quiet, sit-down activity. The Wattman's paper was reweighed immediately after removal. The scale used was a Mettler scale, Model No. PC4400, and the weight was measured in milligrams.

The Drionic unit was a compact battery operated device that delivered a maximum of 25 volts of electricity to the skin surface through two V2 inch thick water soaked wool pads. According to the manufacturer it inhibits sweat through the process of iontophoresis. lontophoresis passes a direct current through the skin to create an irritation to the eccrine sweat duct, producing a hyperkeratinization and resulting in an obstruction or "parakeratonic plug." This "plug" prevents perspiration for a period of time.1-3

Each subject or their parent was familiarized with the correct method of operating the Drionic device according to the manufacturer's guidelines. When full competence was demonstrated to the therapist, the procedure was then done daily on a home program basis.

The treatment procedure was divided into three parts; skin preparation, device preparation, and controlled thirty minute use of the unit. Further recording of pertinent data in a daily diary was made at home along with sweat measurements taken weekly at the Hospital. Prior to treatment the skin was prepared by carefully wiping the selected surface area of the stump with 70% isopropyl alcohol to insure it was clean. Any skin abrasions, irritation, or scratches were covered with petroleum jelly so as to impede the concentration of current and lessen the discomfort to the area. The device was prepared according to the manufacturer's instructions. each child was asked to set the dial at the highest setting he/she could tolerate. (Too low a setting would result in no treatment at all.) The treatment schedule was one 30 minute period each day. At the end of treatment, the machine was turned off and the felt pads were unplugged and rinsed thoroughly with tap water. The treated skin was rinsed with warm water and dried. All findings were recorded in a daily diary and reported to the therapist at the session when the measurements were taken. The data recorded were, a) number of hours prosthesis was worn, b) length of treatment, c) voltage level, and d) adverse reactions (eg. redness or erythema, uncomfortable tingling, scaling, vesicles).

Data Reduction

The measurement of sweat in milligrams for each subject was recorded and averaged for each time period of the design (ie. pretreatment, treatment, and posttreatment). Tests for significance were not performed since there were too few subjects involved in the investigation for the results to be meaningful Therefore discussion will be directed in terms of trends only.

Results

Figures 1 and 2 present the average results for the treatment periods for each subject. Two of the upper limb amputees showed a general decrease in sweat while the third indicated no change (Figure 1 ). For the lower limb amputee subjects varying results occurred but all indicated a lower sweat value posttreatment than pretreatment (Figure 2 ).

When the group means were determined for the upper limb subjects the following results were obtained: 367 mg. (pretreatment), 255 mg. (treatment), and 113 mg. (posttreatment). For the lower limb subjects the results were: 129 mg. (pretreatment), 102 mg. (treatment), and 71 mg. (posttreatment). The results show a trend of reduction of sweat over the ten weeks for each group of children.

Discussion

The purpose of this investigation was to determine the efficacy of the Drionic device in alleviating hyperhidrosis. In the present investigation, although the number of subjects was limited, the measurement of sweat volume of the stumps of the sample amputee children showed a trend for reduced sweating indicating that the Drionic machine was effective. These results are comparable to the iontophoresis studies of Shen et al., (1990),6 Dahl, and Glent-Madsen (1989).7 The first study reported that older patients who underwent treatment in cooler weather had the most favourable results whereas the second study stated that after treatment with tap water iontophoresis in palmer hyperhidrosis, 6 patients showed significant reduction of sweat production.

The age of the subjects who completed this study were between eight to eighteen years. Attempts to use the machine with several younger children three, four, and five years of age were performed, two were below-the-knee amputees and one was a below-elbow amputee. These younger children complained about the unpleasant sensation of the current, would not co-operate during the 30 minute treatment session, and could not reach the maximum voltage. These reactions caused their parents to not wish to continue with the study. Based on their experience, it is believed that this machine would be ill advised for younger children.

The daily diary results were not included in this report since there was no consistency of reporting by any of the subjects throughout the study. All subjects reported a mild discomfort "pins and needle" sensation from the current. None of the six children included in the study had any trouble reaching the highest setting for voltage within the first week of treatment. All children received a mild erythema on their stumps under both of the treatment pads, but this redness dissipated quickly. No children received any undo skin irritations during the four weeks of treatment. All subjects reported a consistent wearing pattern of their prosthesis during this time, and none reported that they had to remove their prosthesis earlier than usual due to discomfort. It should be noted that none of the testing took place during the summer months.

The original design of the study was to continue to test the subjects weekly following the treatment phase to see when the sweat volume increased to its original levels thereby estimating the treatment effects. Unfortunately, compliance of the subjects was a problem and continuing more weekly data collection was not practical. The study was therefore concluded at ten weeks (three weeks posttreatment) and as a result, the length of time that the effect of the treatment persisted was not determined.

Summary and Conclusions

The results of this study indicated a trend of decreasing the amount of sweat on the stumps of six juvenile amputee children who followed the protocol of daily use of the Drionic machine for four weeks.

Although the Drionic machine appeared to work in alleviating perspiration on the stumps of some children over the age of seven years, it was not tolerated by younger children under the age of 6. Because of the necessity of a four week, daily treatment program it is the opinion of the authors that the Drionic machine is not an effective long term solution for hyperhidrosis in children.

Alberta Children's Hospital, 1820 Richmond Road S.W., Calgary, Alberta T2T 5C7

Vol. 27, No. 4, Spring 1993

References:

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  2. Atkins D, Meisenheimer J, et al: Efficacy of the Drionic Unit in the treatment of hyperhidrosis. Journal of the American Academy of Dermatology 16:828-832, 1987.
  3. Peterson JL, Read SI, Rodman OG: A new device in the treatment of hyperhidrosis by iontophoresis. Cutis 19:8289, 1982.
  4. Hersen M, Barlow DH: Single Case Experimental Designs. Pergamon Press, New York, 1976.
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  7. Dahl JC, Glent-Madsen L: Treatment of hyperhidrosis manuum by tap water iontophoresis. Acta DermatoVenereologica 69:346-348, 1989.