To evaluate topical analgesic effect of baclofen, this randomized, double-blind, Placebo control, clinical trial is designed. Patients refer to diabetes clinic with neuropathic pain are chosen and randomized to receive one of two intervention.
Patients with moderate to severe peripheral neuropathy enrolled to the study. Patients with a history of peripheral neuropathy for other reason than diabetes, or treated with oral medicines with analgesic effect on neuropathy ( anticonvulsants, tricyclic antidepressants) and, patients with hypersensitivity to baclofen are excluded. The total sample size is 80 people, forty patients in baclofen group and 40 patients in the placebo group.
For this purpose, baclofen cream 2% is prepared, chemical and physical stability is evaluated in different temperature. Microbial limit test is also performed, same as the United States pharmacopeia method.
In addition to taking oral amitriptyline, patients applied baclofen or placebo cream twice daily, for two weeks. At the end, patients reevaluated for severity of neuropathy. Pain intensity is recorded on first and 14th days after intervention, using Visual analog scale. The lowest grade of pain is considered 0 and the highest grade is 10.