Clinical trial NCT02268344: Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection
Official title: Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection (ESSAN): a Double-blinded, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Head Neck Cancer
Keywords: nerve regeneration
spinal accessory nerve
shoulder function
head neck cancer
electrical stimulation
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Brief intraoperative electrical stimulation of the spinal accessory nerve (ESSAN) continuously at 20 Hz, 10-15V for 60 minutes immediately following neck dissection
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Constant-Murley Score
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Oxford Shoulder Score (OSS)
timeFrame: 6 months postoperatively
measure: Neck Dissection Impairment Index (NDII)
timeFrame: 6 months postoperatively
measure: Nerve Conduction Studies (NCS)
timeFrame: 6 months months postoperatively
measure: Electromyographic (EMG) studies
timeFrame: 6 months postoperatively
measure: University of Washington Quality of Life (UW-QOL) questionnaire
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: Division of Otolaryngology-Head & Neck Surgery, University of Alberta
name: Brittany Barber, MD
role: STUDY_CHAIR
affiliation: Division of Otolaryngology-Head & Neck Surgery, University of Alberta
name: Daniel O'Connell, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Otolaryngology-Head & Neck Surgery, University of Alberta
name: Hadi Seikaly, MD MAL FRCSC
role: STUDY_DIRECTOR
affiliation: Department of Physical Rehabilitation and Medicine, University of Alberta
name: Ming Chan, MD FRCPC
role: STUDY_DIRECTOR
affiliation: Faculty of Rehabilitation Medicine, University of Alberta
name: Margaret McNeely, PT PhD
role: STUDY_DIRECTOR
affiliation: Division of Otolaryngology-Head & Neck Surgery, University of Alberta
name: Jeffrey Harris, MD MHA FRCSC
role: STUDY_CHAIR
affiliation: Division of Plastic Surgery, University of Alberta
name: Jaret Olson, MD FRCSC
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.