NCT02268344: ESSAN

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

Completed NA Last updated 7 May 2020

What this trial tests

NA trial testing Grass SD9 Stimulator in Shoulder Pain in 68 participants. Completed in 6 June 2015.

Timeline

6 October 2014

Primary endpoint
6 June 2015

6 June 2015

Quick facts

Lead sponsor	University of Alberta
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	68
Start date	6 October 2014
Primary completion	6 June 2015
Estimated completion	6 June 2015
Sites	1 location across Canada

Drugs / interventions tested

• Grass SD9 Stimulator

Conditions studied

• Shoulder Pain — all drugs for Shoulder Pain →
• Head Neck Cancer — all drugs for Head Neck Cancer →

Sponsor

University of Alberta

Who can join

Adults 18 to 55, any sex, with Shoulder Pain or Head Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Barber B, Seikaly H, Ming Chan K, Beaudry R, et al · · 2018 · cited 48× · PMID 29361981 · DOI 10.1186/s40463-017-0244-9
2. Intraoperative brief electrical stimulation (BES) for prevention of shoulder dysfunction after oncologic neck dissection: study protocol for a randomized controlled trial.
   Barber B, McNeely M, Chan KM, Beaudry R, et al · · 2015 · cited 14× · PMID 26021563 · DOI 10.1186/s13063-015-0745-7
3. Peripheral nerve repair: innovations and future directions.
   Aldali F, Tang L, Yang Y, Huang Y, et al · · 2026 · PMID 41634808 · DOI 10.1186/s12967-025-07567-z