A Novel Muscle Cramp Scale for Patients with ALS (S54.006)

Objective: To develop a new muscle cramp scale. Background: Clinical trials in the past have utilized a cramp diary that details the number, location, and severity of muscle cramps. Design/Methods: We have developed an outcome measure to assess muscle cramps in ALS, which contains four 5-point subdomains consisting of 1) cramp-triggering factors, 2) frequency, 3) location, 4) severity, and a 5) 10-point visual scale assessing the degree in which the cramp affects overall daily living. Results: Thirty patients with ALS, who experienced a daily cramp or at least 3 cramps per week, participated in a test-retest study. An additional 26 patients participated in a second study assessing changes over 4 weeks using the cramp scale in conjunction with a cramp diary. To assess the internal reliability of the scale, a Cronbach’s coefficient value of α=0.75 was considered acceptable. Test and retest by in-person and telephone administration did not differ, and Cohen’s kappa statistics revealed moderate to high agreement for each item (range 0.60 to 0.95, P Conclusions: This study showed that the ALS muscle cramp scale is a valid, simple, and quick measure that can be administered either in person or by telephone. It can be used for assessment of muscle cramps in patients with ALS. Disclosure: Dr. Mitsumoto has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Mitsubishi-Tanabe Pharma. Dr. Mitsumoto has received research support from Tsumura & Co, Cytokinetics. Dr. Gilmore has nothing to disclose. Dr. Chiuzan has received research support from Tsumura & Co. Dr. Ibagon has nothing to disclose. Dr. Zhang has nothing to disclose. Dr. McHale has nothing to disclose. Dr. Likanje has nothing to disclose. Dr. Hupf has nothing to disclose.