Benifit of iontophoresis?

Question

how it helps us

Answer 1

1.

      Aetna considers iontophoresis medically necessary for either of the following two indications:

         1.

            Sweat test by pilocarpine iontophoresis for the diagnosis of cystic fibrosis; or

         2.

            Intractable, disabling primary hyperhidrosis (see also, CPB 113 - Botulinum Toxin ) when all of the following are met:

               1.

                  Topical aluminum chloride or other extra-strength antiperspirants are ineffective or result in a severe rash; and

               2.

                  Member is unresponsive or unable to tolerate pharmacotherapy prescribed for excessive sweating (e.g., anticholinergics, beta-blockers, or benzodiazapines); and

               3.

                  Significant disruption of professional and/or social life has occurred because of excessive sweating.

   2.

      Aetna considers other uses of iontophoresis (e.g., administration of NSAIDS or corticosteroids for treatment of inflammatory musculoskeletal disorders) experimental and investigational because of insufficient evidence of its effectiveness.

Background

Iontophoresis is the introduction of ionizable drugs through intact skin by the administration of continuous, direct electrical current into the tissues of the body. The sweat test by pilocarpine iontophoresis is the only practical and reliable laboratory test for confirmation of the diagnosis of cystic fibrosis. Localized sweating is stimulated pharmacologically, the amount of sweat is measured, and sodium and chloride levels determined. In patients with a suggestive clinical picture or a positive family history of cystic fibrosis, a chloride concentration greater than 60 mEq/L confirms the diagnosis.

Iontophoresis can be tried for intractable disabling primary hyperhidrosis when antiperspirants or pharmacotherapy are not effective (see CPB 504 - Hyperhidrosis (Hyperhydrosis) ). Iontophoresis has been reported to provide temporary relief in mild cases of primary hyperhidrosis of the hands and feet. The procedure has to be repeated regularly, initially in 20-minute sessions several times a week, gradually stretching out the interval between treatments to 1-2 weeks; however, treatments must be maintained indefinitely to control the symptoms of mild hyperhidrosis. The results vary: many find the electric current uncomfortable, the treatment expensive, time consuming, and the results not lasting long enough. The Drionic® device (General Medical Co., Los Angeles, California) is an iontophoretic device that can be purchased for home use.

There is insufficient evidence that iontophoresis of corticosteroids is effective in treating musculoskeletal disorders. Hasson et al (1992) evaluated the pain alleviating effect of dexamethasone iontophoresis on delayed onset muscle soreness (DOMS) produced via an eccentric exercise bout, and to determine the effect on muscle function. Baseline data were collected on 18 female subjects for maximum isometric knee extension contraction (MVC), knee extension peak torque (PT), knee extension work (W), and muscle soreness perception (SP). All values were subsequently reassessed 24 and 48 hours after a 10-min bout of bench stepping.

Immediately following the 24-hr reassessment, the experimental (E) (n = 6) and placebo (P) (n = 6) groups received iontophoresis treatment while the control (C) group (n = 6) received no treatment. Percent deviation from baseline of SP was significantly less at 48 hours for the E group compared to P and C groups. However, MCV, PT, and W were no different between the three groups at 48 hours post muscle soreness bout. Moreover, this study evaluated an experimentally induced condition (DOMS), thus it has little bearing on clinical musculoskeletal disorders.

Schiffman and colleagues (1996) evaluated the short-term effect of iontophoretic delivery of dexamethasone (DEX) on the signs and symptoms of temporomandibular disorders in patients who had concurrent temporomandibular joint disc displacement without reduction and capsulitis. Twenty-seven patients with this clinical diagnosis were randomized to one of three groups: (i) treatment group (DEX and lidocaine hydrochloride); (ii) control group (lidocaine hydrochloride); and (iii) placebo group (pH-buffered saline). The authors reported that iontophoretic delivery of DEX and lidocaine was effective in improving mandibular function, but not in reducing pain, in temporomandibular disorders patients who had concurrent temporomandibular joint capsulitis and disc displacement without reduction.

Li and associates (1996) examined the effectiveness of DEX iontophoresis for the treatment of rheumatoid arthritis (RA) of the knee in a pilot study. Ten subjects with RA were randomly assigned to either the experimental or placebo group. Iontophoresis treatments were given to both groups on days 1, 3, and 5. Five subjects in the experimental group received a mixture of 1 ml of DEX (4 mg/ml) and 1 ml of injectable sterile water; those in the placebo group received 2 ml of saline solution. Pain on movement, at rest, and on pressure, active joint count, and active range of motion, were evaluated on days 1, 5, and 20. The results suggested that DEX iontophoresis is more effective than placebo in relieving pain at rest and on movement in the RA knee. The finding of this small study needs to be verified by studies with larger sample size and longer follow-ups.

Gudeman and co-workers (1997) investigated whether iontophoresis of DEX in conjunction with other traditional modalities provides more immediate pain relief than traditional modalities alone. Forty affected feet were randomly assigned to one of two groups. In Group I, feet were treated with traditional modalities and placebo iontophoresis. In Group II, feet received the traditional modalities plus iontophoresis of dexamethasone. Both groups were treated 6 times over a 2-week period. The authors reported that although traditional modalities alone are ultimately effective, iontophoresis in conjunction with traditional modalities provides immediate reduction in symptoms.

Most studies of iontophoresis for other indications are not well designed. The studies have small sample sizes, lack appropriate control groups, and usually do not have objective outcome measures. As a result, it is still unclear whether iontophoresis (of a certain drug/agent) is clinically effective or that iontophoresis of the drug/agent is more effective than other forms of treatment. More research, especially randomized, controlled studies with large sample sizes and sound statistical analysis, is needed to ascertain the effectiveness of iontophoresis for the treatment of such conditions as temporomandibular joint disorders, musculoskeletal/soft tissue injuries, herpes labialis, and post-herpetic neuralgia.

Baskurt et al (2003) reported that iontophoresis and phonophoresis of naproxen are equally effective electrotherapy methods in the treatment of lateral epicondylitis (n = 61 patients). The main drawback of this study is the lack of a placebo control group. Furthermore, the findings of this study are confounded by the fact that both groups were treated by other physiotherapy methods such as cold pack, progressive strengthening and stretching exercises. Thus, it is unclear whether the improvement is due to iontophoresis/phonophoresis or other physiotherapy methods.

Neeter et al (2003) evaluated the effects of iontophoresis with dexamethasone (n = 14) to iontophoresis with saline solution (n = 11) on patients who had acute (less than 3 months) pain from the Achilles tendon, in terms of range of motion, muscular endurance, pain and symptoms. Patients were evaluated before and after 2 weeks of treatment with iontophoresis, as well as after 6 weeks, 3 and 6 months and 1 year. Both groups then followed the same rehabilitation program for 10 weeks. Good reliability was found for the toe-raise and range of motion tests. Poor reliability was, however, found for the pain on palpation test, which was excluded. No difference was found between or within groups for the toe-raise test. Several significant improvements were seen in the experiment group but not in the control group, in the range of motion test, pain during and after physical activity, pain during walking and walking up and down stairs, morning stiffness and tendon swelling. These investigators concluded that iontophoresis with dexamethasone were found to have a positive effect in the treatment of patients with acute Achilles tendon pain. This was a small study (n = 25), albeit it a randomized one. The small sample size limited the possibilities to draw definite conclusions from the present findings.

Nirschl et al (2003) studied the effects of iontophoretic administration of DEX in controlling pain in patients with medial or lateral elbow epicondylitis. A total of 199 patients with elbow epicondylitis received 40 mA-minutes of either active or placebo treatment. Dexamethasone produced a significant 23-mm improvement on the 100-mm patient visual analog scale (VAS) ratings, compared with 14 mm for placebo at 2 days and 24 mm compared with 19 mm at 1 month. More patients treated with DEX than those treated with placebo scored moderate or better on the investigator's global improvement scale (52 % versus 33 %) at 2 days, but the difference was not significant at 1 month (54 % versus 49 %). Investigator-rated pain and tenderness scores favored DEX over placebo at 2 days. Patients completing six treatments in 10 days or less had better results than those treated over a longer period. The authors concluded that iontophoresis treatment was well tolerated by most patients and was effective in reducing symptoms of epicondylitis at short-term follow-up. There appears to be little difference in VAS rating at 1 month between the two groups which corresponded with the investigator's global improvement scale (54 % versus 49 %).