Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection

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.

Conditions

• Shoulder Pain
• Head Neck Cancer

Interventions

DEVICE

Grass SD9 Stimulator

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.

Sponsors & Collaborators

• University of Alberta

  lead OTHER

Principal Investigators

• Brittany Barber, MD · Division of Otolaryngology-Head & Neck Surgery, University of Alberta

• Daniel O'Connell, MD MSc FRCSC · Division of Otolaryngology-Head & Neck Surgery, University of Alberta

• Hadi Seikaly, MD MAL FRCSC · Division of Otolaryngology-Head & Neck Surgery, University of Alberta

• Ming Chan, MD FRCPC · Department of Physical Rehabilitation and Medicine, University of Alberta

• Margaret McNeely, PT PhD · Faculty of Rehabilitation Medicine, University of Alberta

• Jeffrey Harris, MD MHA FRCSC · Division of Otolaryngology-Head & Neck Surgery, University of Alberta

• Jaret Olson, MD FRCSC · Division of Plastic Surgery, University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-06

Primary Completion

2015-06-06

Completion

2015-06-06

Countries

• Canada

Study Locations