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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain; Head Neck Cancer
• Intervention / Treatment: Device: Grass SD9 Stimulator

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-55 years
• New adult head and neck cancer patients
• Undergoing major resection and reconstruction surgery including oncologic neck dissection including Level IIb
• Undergoing adjuvant therapy

Exclusion Criteria:

• Oncologic resection necessitating unilateral or bilateral resection of the sternocleidomastoid, SAN, partial resection of trapezius muscle, hypoglossal nerve, skin, carotid resection, or deep muscle resection
• Previous surgery or radiation therapy to the head and/or neck
• Recurrent head and neck cancer
• Preoperative, pre-existing shoulder dysfunction or weakness, including myopathy, neuropathy, or arthropathy
• Presence of existing implanted electrical device (eg. pacemaker, deep brain stimulator, vagal nerve stimulator
• Previous or current neurological disease which may adversely affect shoulder dysfunction
• Unable to read, write, and speak English
• Lacking capacity to give consent
• Unwilling to present for follow-up appointments or follow-up objective shoulder assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Grass SD9 Stimulator; Brief intraoperative electrical stimulation of the spinal accessory nerve (ESSAN) continuously at 20 Hz, 10-15V for 60 minutes immediately following neck dissection.	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.; Other Names: Electrical Stimulation (ES)
NO_INTERVENTION: No Stimulation; No stimulation will be performed in this group, and patients will simply have the neck dissection as planned. No sham stimulation is required, as all outcome measures are performed by individuals not present in the operating room, and therefore, blinded to the treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant-Murley Score	The Constant-Murley score is a 100-point scale composed of a number of individual parameters, detailing the level of shoulder pain and the ability to carry out normal daily activities of the patient. The Constant-Murley Score is a 100-point scale composed of a number of individual parameters, designed to determine functionality after shoulder treatment. It includes includes 4 subscales that assess pain, activities of daily living, strength, and range of motion (forward elevation, external rotation, abduction, and internal rotation of the shoulder). A higher score indicates higher quality of function.	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Shoulder Score (OSS)	The OSS is a 12-item, multi-dimensional, self-report questionnaire regarding shoulder-specific daily activity in the previous 4 weeks.	6 months postoperatively
Neck Dissection Impairment Index (NDII)	The Neck Dissection Impairment Index (NDII), is a 10-item self-report questionnaire using a 5-point Likert scale for assessment of shoulder impairment after neck dissection.	6 months postoperatively
Nerve Conduction Studies (NCS)	This will include conduction velocity and amplitude as it relates to nerve injury during oncologic neck dissection.	6 months months postoperatively
Electromyographic (EMG) studies	This will pertain to electrophysiologic thresholds necessary to evoke a motor response from the trapezius and sternocleidomastoid, to evaluate nerve function.	6 months postoperatively
University of Washington Quality of Life (UW-QOL) questionnaire	This instrument will be used to asses quality of life (QOL) differences between the study and placebo groups following treatment.	6 months postoperatively

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Study Chair: Brittany Barber, MD, Division of Otolaryngology-Head & Neck Surgery, University of Alberta; Principal Investigator: Daniel O'Connell, MD MSc FRCSC, Division of Otolaryngology-Head & Neck Surgery, University of Alberta; Study Director: Hadi Seikaly, MD MAL FRCSC, Division of Otolaryngology-Head & Neck Surgery, University of Alberta; Study Director: Ming Chan, MD FRCPC, Department of Physical Rehabilitation and Medicine, University of Alberta; Study Director: Margaret McNeely, PT PhD, Faculty of Rehabilitation Medicine, University of Alberta; Study Chair: Jeffrey Harris, MD MHA FRCSC, Division of Otolaryngology-Head & Neck Surgery, University of Alberta; Study Chair: Jaret Olson, MD FRCSC, Division of Plastic Surgery, University of Alberta

Publications and helpful links

General Publications

• Barber B, Seikaly H, Ming Chan K, Beaudry R, Rychlik S, Olson J, Curran M, Dziegielewski P, Biron V, Harris J, McNeely M, O'Connell D. Intraoperative Brief Electrical Stimulation of the Spinal Accessory Nerve (BEST SPIN) for prevention of shoulder dysfunction after oncologic neck dissection: a double-blinded, randomized controlled trial. J Otolaryngol Head Neck Surg. 2018 Jan 23;47(1):7. doi: 10.1186/s40463-017-0244-9.
• Barber B, McNeely M, Chan KM, Beaudry R, Olson J, Harris J, Seikaly H, O'Connell D. Intraoperative brief electrical stimulation (BES) for prevention of shoulder dysfunction after oncologic neck dissection: study protocol for a randomized controlled trial. Trials. 2015 May 30;16:240. doi: 10.1186/s13063-015-0745-7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 6, 2014
• Primary Completion (ACTUAL): June 6, 2015
• Study Completion (ACTUAL): June 6, 2015

Study Registration Dates

• First Submitted: October 10, 2014
• First Submitted That Met QC Criteria: October 15, 2014
• First Posted (ESTIMATE): October 20, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: electrical stimulation; spinal accessory nerve; shoulder function; nerve regeneration; head neck cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Head and Neck Neoplasms; Shoulder Pain
• Other Study ID Numbers: pro00046671