[S20.006] Botulinum Toxin For Muscle Cramps Associated With Diabetic Neuropathy: A Double-Blind, Placebo-Controlled Study
Domenico Antonio Restivo,1Antonio Pavone, 1Damiano Gullo,1Stefano Jann,2Riccardo Vigneri1
1Catania, Italy, 2Milan, Italy
OBJECTIVE: The aim of the present study was to evalute the effect of BoNT/A in reducing the severity and the frequency of occurrences of cramps in patients with diabetic neuropathy. BACKGROUND: muscle cramp is a painful, involuntary, paroxysmal muscle contraction observed in several neurological and metabolic diseases other than in a number of physiological conditions including muscle fatigue, pregnancy, and in elderly. The association of muscle cramps with diabetes mellitus (DM), as well as with diabetic peripheral neuropathy, has been known for several years.
No pharmacological treatment has shown to provide adequate relief in reducing cramp-associated pain. Botulinum toxin type A (BoNT/A) has demonstrated to be effective in reducing cramp frequency and severity in patients with benign cramp-fasciculations syndrome.
DESIGN/METHODS: In this double-blind, randomized trial, thirty patients with diabetic neuropathy and frequent leg cramps underwent BoNT/A injections (N=15) or normal saline (N=15).
Primary outcome: variation in the mean intensity of cramping pain (on a scale from 0 to 10). Secondary outcomes: variations in the number of occurrences; variations in the electrophysiologically measured Cramp Threshold Frequency (CTF); variations in the Cramp Severity Scale (CSS). Patients were evaluated before, and at week 1, 4, 8, 12, 16, 20 after injections. RESULTS: all the outcome measures showed significant changes in the treated group as compared with placebo. The effect appeared at week 1, and persisted untill week 16, disappearing at week 20. CONCLUSIONS: BoNT/A can be a safe and promising treatment for painful cramps associated with diabetic neuropathy.
Category - Pain and Palliative Care: Clinical: Treatment
Tuesday, April 29, 2014 4:30 PM
S20: Platform Session: Pain and Palliative Care (3:15 PM-5:00 PM)