Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection
Condition: Shoulder Pain; Head Neck Cancer
MeSH terms: Head and Neck Neoplasms; Shoulder Pain
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Grass SD9 Stimulator
Intervention type(s): Device
Intervention description(s): Electrical stimulation will be applied to the nerve using the Grass SD9 Stimulator at a frequency of 20Hz, 10-15V, for 60 minutes during the surgery. This will occur after the neck dissection has been completed, and the remainder of the surgery will continue during stimulation. The stimulation will be applied using the Grass SD9 Stimulator and the current will be conducted to the nerve using a sterile wire electrode that will be encircled around the nerve at its most proximally-exposed portion (skull base). The wire will be removed after 60 minutes of stimulation has been applied.
Other intervention name(s): Electrical Stimulation (ES)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Brief intraoperative electrical stimulation of the spinal accessory nerve (ESSAN) continuously at 20 Hz, 10-15V for 60 minutes immediately following neck dissection
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: nerve regeneration; spinal accessory nerve; shoulder function; head neck cancer; electrical stimulation