Shoulder Pain Clinical Trial
Official title:
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
dissection.
Methods: All adult patients with a new diagnosis of HNC undergoing surgery with neck
dissection including Level IIb and postoperative radiotherapy 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.
This study will be conducted as a randomized, double-blinded, placebo-controlled trial. Two parallel treatment groups will be examined with a 1:1 allocation: 1) brief intraoperative electrical stimulation continuously at 20 Hz at an intensity of 1.5 times the motor threshold for 60 minutes, or 2) sham/no stimulation for 60 minutes. Individuals will be allocated to treatment groups using a block randomization sequence. Participants and researchers measuring outcomes will be blinded to treatment groups. Stimulation (BES or sham) will occur intraoperatively immediately following neck dissection for 60 minutes. ;
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