INTRODUCTION: Nonthermal lasers provide pain relief for a variety of musculoskeletal disorders and improve physical functioning. A nonthermal laser that employs a 635 nm red diode is cleared for the temporary reduction of neck and shoulder pain of musculoskeletal origin. As a 405 nm violet laser has shown synergy with the 635 nm red laser when used together for treating other conditions, the objective of this study was to compare the efficacy of 635 nm red and 405 nm violet lasers versus the 635 nm red laser for treating neck and shoulder pain of musculoskeletal origin. MATERIALS AND METHODS: Otherwise healthy adult subjects with chronic neck or shoulder pain for >= 30 days were enrolled and randomized to receive a single 13-min treatment with combined red and violet lasers (n = 44) or the red laser alone (n = 43). The primary efficacy measure was change in baseline VAS pain scores 3 mins after treatment. Subject success was predefined as a >= 30% decrease in VAS scores and study success was predefined as 65 +/- 5% individual subject successes. RESULTS: Among subjects treated with the red and violet lasers, mean VAS neck and shoulder pain scores decreased from 65.0 to 35.2 (p < 0.0001). Most subjects in the study (75%) achieved >= 30% decrease in VAS scores. The decreased mean (SD) VAS scores remained 29.6 (16.7) and 29.3 (19.2) after 24 and 48 hrs, respectively. The secondary efficacy measures of change in range of motion ROM) and patient satisfaction also improved. There were no adverse events. CONCLUSION: Overall, treatment with the red and violet lasers outperformed the FDA-approved red laser with respect to change in pain scores and improvement in shoulder ROM.

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