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

NCT02268344 | Completed DMC

• 1 other identifier: pro00046671
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

nerve regeneration; spinal accessory nerve; shoulder function; head neck cancer; electrical stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Oxford Shoulder Score (OSS)

  6 months postoperatively

• Neck Dissection Impairment Index (NDII)

  6 months postoperatively

• Nerve Conduction Studies (NCS)

  6 months months postoperatively

• Electromyographic (EMG) studies

  6 months postoperatively

• University of Washington Quality of Life (UW-QOL) questionnaire

  6 months postoperatively

Study Arms (2)

Grass SD9 Stimulator

ACTIVE COMPARATOR

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

No Stimulation

NO INTERVENTION

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.

Interventions

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.

Also known as: Electrical Stimulation (ES)

Grass SD9 Stimulator

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (2)

• 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.

  PMID: 29361981 BACKGROUND

• 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.

  PMID: 26021563 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Head and Neck Neoplasms

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Brittany Barber, MD

  Division of Otolaryngology-Head & Neck Surgery, University of Alberta

  STUDY CHAIR

• Daniel O'Connell, MD MSc FRCSC

  Division of Otolaryngology-Head & Neck Surgery, University of Alberta

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Brief intraoperative electrical stimulation of the spinal accessory nerve (ESSAN) continuously at 20 Hz, 10-15V for 60 minutes immediately following neck dissection

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 20, 2014
• Study Start: October 6, 2014
• Primary Completion: June 6, 2015
• Study Completion: June 6, 2015
• Last Updated: May 7, 2020

Record last verified: 2020-05

Locations

CA (1)