O B J E C T I V E— To evaluate the efficacy of combining electrotherapy with amitriptyline for the management of chronic painful peripheral neuropathy in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS— Patients (n = 26) with peripheral neuro p athy were treated with amitriptyline. After 4 weeks, those patients (n = 23) who failed to re s p o n d to amitriptyline or who only had partial relief were randomized between a sham tre a t m e n t g roup (control) or an electrotherapy group. Transcutaneous electrotherapy was given for 12 weeks by a portable unit (H-wave machine) that generated a biphasic exponentially decaying w a v e f o rm (pulse width 4 ms, 25–35 V, 2 Hz). The degree of pain and discomfort was graded on a scale of 0–5. An analog scale was used to re c o rd the overall change in symptoms.
R E S U LT S— Amitriptyline produced some degree of symptomatic relief in 15 (60%) of the 26 patients by the 4th week; pain scores decreased from 3.8 ± 0.1 to 2.9 ± 0.2 (P 0.1) and the overall reduction in pain was 26 ± 5% on an analog scale. In the amitriptyline plus sham treatment group (n = 9), pain scores declined from 2.8 ± 0.3 to 1.9 ± 0.5 (P 0.03) and the overall reduction in pain was 55 ± 12%, suggesting a pro c e d u re – related placebo effect. In the group receiving combined electrotherapy and amitriptyline (n = 14), symptomatic impro v ement occurred in 12 (85%) patients. Five (36%) of the patients in this group became asymptomatic. Pain scores declined from 3.2 ± 0.2 to 1.4 ± 0.4 (P 0.01) and the overall re d u c t i o n in pain was 66 ± 10%. The degree of reduction in pain scores and the incremental relief (above the amitriptyline effect) were significantly greater (P 0.03) with electrotherapy as compare d with sham treatment. The outcomes indicate a substantial beneficial effect of electro t h e r a p y over and above any placebo influ e n c e . C O N C L U S I O N S— Our clinical observations suggest that transcutaneous electrotherapy is effective in reducing the pain associated with peripheral neuro p a t h y. This form of therapy may be a useful adjunctive modality when it is combined with a pharmacological agent, such as amitriptyline, to augment symptomatic re l i e f .
Xanya Sofra Weiss