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

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ClinicalTrials.gov Identifier: NCT02268344
Recruitment Status : Unknown
Verified June 2015 by University of Alberta.
Recruitment status was:  Recruiting
First Posted : October 20, 2014
Last Update Posted : June 18, 2015
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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.


Condition or disease Intervention/treatment Phase
Shoulder Pain Head Neck Cancer Device: Grass SD9 Stimulator Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection (ESSAN): a Double-blinded, Randomized Control Trial
Study Start Date : July 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : July 2016

Arm Intervention/treatment
Active Comparator: 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.
Device: 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.
Other Name: Electrical Stimulation (ES)

No Intervention: 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.



Primary Outcome Measures :
  1. Constant-Murley Score [ Time Frame: 6 months postoperatively ]
    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.


Secondary Outcome Measures :
  1. Oxford Shoulder Score (OSS) [ Time Frame: 6 months postoperatively ]
    The OSS is a 12-item, multi-dimensional, self-report questionnaire regarding shoulder-specific daily activity in the previous 4 weeks.

  2. Neck Dissection Impairment Index (NDII) [ Time Frame: 6 months postoperatively ]
    The Neck Dissection Impairment Index (NDII), is a 10-item self-report questionnaire using a 5-point Likert scale for assessment of shoulder impairment after neck dissection.

  3. Nerve Conduction Studies (NCS) [ Time Frame: 6 months months postoperatively ]
    This will include conduction velocity and amplitude as it relates to nerve injury during oncologic neck dissection.

  4. Electromyographic (EMG) studies [ Time Frame: 6 months postoperatively ]
    This will pertain to electrophysiologic thresholds necessary to evoke a motor response from the trapezius and sternocleidomastoid, to evaluate nerve function.

  5. University of Washington Quality of Life (UW-QOL) questionnaire [ Time Frame: 6 months postoperatively ]
    This instrument will be used to asses quality of life (QOL) differences between the study and placebo groups following treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268344


Contacts
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Contact: Brittany Barber, MD 17809935954 brittanybarber0@gmail.com
Contact: Daniel O'Connell, MD MSc FRCSC 17804977250 daniel.o'connell@albertahealthservices.ca

Locations
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Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Brittany Barber, MD    17809935954    brittanybarber0@gmail.com   
Sponsors and Collaborators
University of Alberta
Investigators
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Study Chair: Brittany Barber, MD Division of Otolaryngology-Head & Neck Surgery, University of Alberta
Principal Investigator: Daniel O'Connell, MD MSc FRCSC Division of Otolaryngology-Head & Neck Surgery, University of Alberta
Study Director: 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 Chair: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02268344     History of Changes
Other Study ID Numbers: pro00046671
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: June 2015

Keywords provided by University of Alberta:
nerve regeneration
spinal accessory nerve
shoulder function
head neck cancer
electrical stimulation

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Shoulder Pain
Neoplasms by Site
Neoplasms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms