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Clinical trialNCT02268344CompletedInterventional

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

SponsorUniversity of AlbertaEnrollment68Head Neck CancerShoulder Pain
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • 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
  • Jaret Olson, MD FRCSC

    Division of Plastic Surgery, University of Alberta

    Study Chair
  • Jeffrey Harris, MD MHA FRCSC

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

    Study Chair
  • Margaret McNeely, PT PhD

    Faculty of Rehabilitation Medicine, University of Alberta

    Study Director
  • Ming Chan, MD FRCPC

    Department of Physical Rehabilitation and Medicine, University of Alberta

    Study Director

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • University of Alberta

    Edmonton, Alberta, Canada

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
6 Oct 2014
Primary completion
6 Jun 2015
Completion
6 Jun 2015
Last update posted
7 May 2020
Registered enrollment
68
Registry id
NCT02268344

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.