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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Brittany Barber, MDemail@example.com|
|Contact: Daniel O'Connell, MD MSc FRCSCfirstname.lastname@example.org|
|University of Alberta||Recruiting|
|Edmonton, Alberta, Canada, T6G 2B7|
|Contact: Brittany Barber, MD 17809935954 email@example.com|
|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|