Status:
COMPLETED
Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection
Lead Sponsor:
University of Alberta
Conditions:
Shoulder Pain
Head Neck Cancer
Eligibility:
All Genders
18-55 years
Phase:
NA
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, activitie...
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 stimula...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2015
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT02268344
Start Date
October 6 2014
End Date
June 6 2015
Last Update
May 7 2020
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7