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NCT Number: NCT02268344

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

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.

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Key information

Conditions

Shoulder Pain Arthralgia Head Neck Cancer Head and Neck Neoplasms Joint Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grass SD9 Stimulator

Device

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)

Primary outcomes

  1. Constant-Murley Score

    Time frame: 6 months postoperatively

    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.

Secondary outcomes

  1. Oxford Shoulder Score (OSS)

    Time frame: 6 months postoperatively

    The OSS is a 12-item, multi-dimensional, self-report questionnaire regarding shoulder-specific daily activity in the previous 4 weeks.

  2. Neck Dissection Impairment Index (NDII)

    Time frame: 6 months postoperatively

    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.

  3. Nerve Conduction Studies (NCS)

    Time frame: 6 months months postoperatively

    This will include conduction velocity and amplitude as it relates to nerve injury during oncologic neck dissection.

  4. Electromyographic (EMG) studies

    Time frame: 6 months postoperatively

    This will pertain to electrophysiologic thresholds necessary to evoke a motor response from the trapezius and sternocleidomastoid, to evaluate nerve function.

  5. University of Washington Quality of Life (UW-QOL) questionnaire

    Time frame: 6 months postoperatively

    This instrument will be used to asses quality of life (QOL) differences between the study and placebo groups following treatment.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection (ESSAN): a Double-blinded, Randomized Control Trial

Acronym: ESSAN

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 20, 2014
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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