Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection (ESSAN): a Double-blinded, Randomized Control Trial
Introduction: Shoulder pain and dysfunction is common after oncologic neck dissection for
head and neck cancer (HNC). These symptoms can hinder postoperative rehabilitation and oral
hygiene, activities of daily living (ADLs), and return to work after treatment. Due to the
rising incidence of Human papillomavirus (HPV)-associated oropharyngeal cancer, patients are
often diagnosed in the 3rd or 4th decade of life, leaving many potential working years lost.
Brief electrical stimulation (BES) is a novel technique that has been shown to enhance
neuronal regeneration after injury through a brain-derived neurotrophic growth factor
(BDNF)-driven molecular pathway. The aim of this study is to examine the utility of
intraoperative BES in prevention of shoulder pain and dysfunction after oncologic neck
Methods: All adult patients with a new diagnosis of HNC undergoing surgery with neck
dissection including Level IIb and postoperative radiation therapy will be enrolled. Patients
will undergo intraoperative BES after completion of neck dissection for 60 minutes
continuously at 20 Hz with an intensity of 1.5 times the motor threshold. Postoperatively,
patients will be evaluated using the Constant-Murley Shoulder Score, a scale that assesses
shoulder pain, activities of daily living (ADLs), strength, and range of motion. Secondary
outcomes measured will include scores on the Oxford Shoulder Score, the Neck Dissection
Impairment Index (NDII), and the University of Washington Quality of Life (UW-QOL) score.
Primary and secondary outcomes will be assessed at 1, 2, 3, 6, and 12 months
postoperatively. Study and placebo groups will be compared using a Mann-Whitney analysis.
View this trial on ClinicalTrials.gov
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