Ignite Creation Date:
2024-05-06 @ 3:20 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02268344
Status:
COMPLETED
Last Update Posted:
2020-05-07
First Post:
2014-10-10
Brief Title:
Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection ESSAN a Double-blinded Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESSAN
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 15 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
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 15 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 11 allocation 1 brief intraoperative electrical stimulation continuously at 20 Hz at an intensity of 15 times the motor threshold for 60 minutes or 2 shamno 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None