Shoulder Pain Clinical Trial
— ESSANOfficial title:
Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection (ESSAN): a Double-blinded, Randomized Control Trial
Verified date | May 2020 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | June 6, 2015 |
Est. primary completion date | June 6, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Constant-Murley Score | 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. | 6 months postoperatively | |
Secondary | Oxford Shoulder Score (OSS) | The OSS is a 12-item, multi-dimensional, self-report questionnaire regarding shoulder-specific daily activity in the previous 4 weeks. | 6 months postoperatively | |
Secondary | Neck Dissection Impairment Index (NDII) | 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. | 6 months postoperatively | |
Secondary | Nerve Conduction Studies (NCS) | This will include conduction velocity and amplitude as it relates to nerve injury during oncologic neck dissection. | 6 months months postoperatively | |
Secondary | Electromyographic (EMG) studies | This will pertain to electrophysiologic thresholds necessary to evoke a motor response from the trapezius and sternocleidomastoid, to evaluate nerve function. | 6 months postoperatively | |
Secondary | University of Washington Quality of Life (UW-QOL) questionnaire | This instrument will be used to asses quality of life (QOL) differences between the study and placebo groups following treatment. | 6 months postoperatively |
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