Purpose: To investigate the neurologic and functional effect of intracordal hyaluronate injections in acute unilateral vocal fold paralysis (UVFP) in a randomized controlled trial.
Methods: In this open-label, randomized controlled study, 29 patients with UVFP were recruited within 6 months of their first outpatient visit and were randomized to receive either single hyaluronate injection (HI group) or conservative management (CM group). Quantitative laryngeal electromyography, videolaryngostroboscopy, UVFP-related quality of life (Voice Outcomes Survey, VOS), laboratory voice analysis, and health-related quality of life (SF-36) were evaluated at baseline, and at 1, 3 and 6 months post-injection in the HI group, and at baseline and 6 months in the CM group.
Results: Improvements in most quality of life domains and other assessments were comparable between the HI and CM groups; however, the HI group had a greater improvement in the mental health domain of quality of life at the end of follow-up.
Conclusions: Early hyaluronate injection cannot improve nerve regeneration but can result in long-lasting improvements in patients' psychosocial well-being, thus highlighting the importance of early intervention for patients with UVFP.
Trial registration: ClinicalTrials.gov NCT02163772.
Keywords: Unilateral vocal fold paralysis; glottal gap; hyaluronate; injection laryngoplasty; laryngeal electromyography; quality of life.