BACKGROUND: The use of cold treatment to limit edema, decrease pain, and induce effective muscle relaxation in soft tissue injuries is widespread. PURPOSE: To compare the efficacy of a novel cold gel with that of a placebo gel in patients with a soft tissue injury. STUDY DESIGN: Prospective randomized double-blinded controlled study. METHODS:Seventy-four patients with sports-related soft tissue injury were randomly assigned to active cold gel (Ice Power) or placebo gel groups. The gel was applied four times daily on the skin for 14 days. Clinical assessment was made after 7, 14, and 28 days with use of visual analog scale ratings. RESULTS:Pain scores decreased from 59 to 30 during the first week, to 14 by the second, and to 7 by the end of study in the cold gel group. In the placebo group, pain scores decreased from 58 to 45, 26, and 13, respectively (significant difference). Patient satisfaction with treatment was 71 in the cold gel group and 44 in the placebo group (significant difference). Disability decreased significantly more rapidly in the cold gel group. CONCLUSIONS:Cold gel therapy provided an effective and safe treatment for sports-related soft tissue injuries.
RCT Entities:
BACKGROUND: The use of cold treatment to limit edema, decrease pain, and induce effective muscle relaxation in soft tissue injuries is widespread. PURPOSE: To compare the efficacy of a novel cold gel with that of a placebo gel in patients with a soft tissue injury. STUDY DESIGN: Prospective randomized double-blinded controlled study. METHODS: Seventy-four patients with sports-related soft tissue injury were randomly assigned to active cold gel (Ice Power) or placebo gel groups. The gel was applied four times daily on the skin for 14 days. Clinical assessment was made after 7, 14, and 28 days with use of visual analog scale ratings. RESULTS:Pain scores decreased from 59 to 30 during the first week, to 14 by the second, and to 7 by the end of study in the cold gel group. In the placebo group, pain scores decreased from 58 to 45, 26, and 13, respectively (significant difference). Patient satisfaction with treatment was 71 in the cold gel group and 44 in the placebo group (significant difference). Disability decreased significantly more rapidly in the cold gel group. CONCLUSIONS: Cold gel therapy provided an effective and safe treatment for sports-related soft tissue injuries.
Authors: Natalia Mejia; Karl Dedow; Lindsey Nguy; Patrick Sullivan; Sepideh Khoshnevis; Kenneth R Diller Journal: J Med Device Date: 2015-08-06 Impact factor: 0.582