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

NCT ID: NCT02268344

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-06
• Study Completion Date: 2015-06-06

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.

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.

Conditions

Shoulder Pain; Head Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Grass SD9 Stimulator

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Electrical Stimulation (ES)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brittany Barber, MD

Role: STUDY_CHAIR

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

Daniel O'Connell, MD MSc FRCSC

Role: PRINCIPAL_INVESTIGATOR

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

Hadi Seikaly, MD MAL FRCSC

Role: STUDY_DIRECTOR

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

Ming Chan, MD FRCPC

Role: STUDY_DIRECTOR

Department of Physical Rehabilitation and Medicine, University of Alberta

Margaret McNeely, PT PhD

Role: STUDY_DIRECTOR

Faculty of Rehabilitation Medicine, University of Alberta

Jeffrey Harris, MD MHA FRCSC

Role: STUDY_CHAIR

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

Jaret Olson, MD FRCSC

Role: STUDY_CHAIR

Division of Plastic Surgery, University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 29361981 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26021563 (View on PubMed)

Other Identifiers

pro00046671

Identifier Type: -

Identifier Source: org_study_id