PMID- 26021563 OWN - NLM STAT- MEDLINE DCOM- 20160229 LR - 20220408 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 16 DP - 2015 May 30 TI - Intraoperative brief electrical stimulation (BES) for prevention of shoulder dysfunction after oncologic neck dissection: study protocol for a randomized controlled trial. PG - 240 LID - 10.1186/s13063-015-0745-7 [doi] LID - 240 AB - BACKGROUND: Shoulder pain and dysfunction are common after oncologic neck dissection for head and neck cancer (HNC), due to traction, compression, and devascularization injuries to the spinal accessory nerve (SAN). Shoulder pain and dysfunction can hinder postoperative rehabilitation and hygiene, activities of daily living (ADLs), and return to work after treatment for HNC. Due to the rising incidence of human papillomavirus (HPV)-associated oropharyngeal cancer, patients are often diagnosed in the third or fourth decade of life, leaving many potential working years lost if shoulder dysfunction occurs. Brief electrical stimulation (BES) is a novel technique that has been shown to enhance and accelerate neuronal regeneration after injury through a brain-derived neurotrophic growth factor (BDNF)-driven molecular pathway in multiple peripheral nerves in both humans and animals. METHODS/DESIGN: This is a randomized controlled trial testing the effect of intraoperative BES on postoperative shoulder pain and dysfunction. All adult participants with a new diagnosis of HNC undergoing surgery with neck dissection, including Level IIb and postoperative radiotherapy, will be enrolled. Participants will undergo intraoperative BES after completion of neck dissection for 60 min continuously at 20 Hz, 3 to 5 V, in 100-msec pulses. Postoperatively, participants will be evaluated using the Constant-Murley Shoulder Score, a scale that assesses shoulder pain, ADLs, strength, and range of motion. Secondary outcomes measured will include nerve conduction studies (NCS) and electromyographic (EMG) studies, as well as scores on the Oxford Shoulder Score (OSS), 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 6 weeks, 3 months, 6 months, and 12 months. DISCUSSION: The objective of this study is to evaluate the effect of BES on postoperative clinical and objective shoulder functional outcomes and pain after oncologic neck dissection. BES has been shown to be successful in accelerating peripheral nerve regeneration in both animal and human participants in multiple different peripheral nerves. If successful, this technique may provide an adjunctive prevention option for shoulder pain and dysfunction in HNC patients. TRIAL REGISTRATION: NCT02268344: 17 October 2014. FAU - Barber, Brittany AU - Barber B AD - 1E4, Walter Mackenzie Center, University of Alberta Hospital, 8440-112 St, Edmonton, AB, T6G 2B7, Canada. brittanybarber0@gmail.com. FAU - McNeely, Margaret AU - McNeely M AD - 3-41 Corbett Hall, University of Alberta, Edmonton, AB, T6G 2G4, Canada. mmcneely@ualberta.ca. FAU - Chan, K Ming AU - Chan KM AD - Center for Neuroscience, 5-005 Katz Group Center, University of Alberta, Edmonton, AB, T6G 2E1, Canada. Ming.chan@ualberta.ca. FAU - Beaudry, Rhys AU - Beaudry R AD - 3-41 Corbett Hall, University of Alberta, Edmonton, AB, T6G 2G4, Canada. Rhys.beaudry@ualberta.ca. FAU - Olson, Jaret AU - Olson J AD - 2D3 Walter Mackenzie Center, University of Alberta, 8440-112 St, Edmonton, AB, T6G 2B7, Canada. jolson@ualberta.ca. FAU - Harris, Jeffrey AU - Harris J AD - 1E4, Walter Mackenzie Center, University of Alberta Hospital, 8440-112 St, Edmonton, AB, T6G 2B7, Canada. Jeffrey.harris@albertahealthservices.ca. FAU - Seikaly, Hadi AU - Seikaly H AD - 1E4, Walter Mackenzie Center, University of Alberta Hospital, 8440-112 St, Edmonton, AB, T6G 2B7, Canada. Hadi.seikaly@albertahealthservices.ca. FAU - O'Connell, Daniel AU - O'Connell D AD - 1E4, Walter Mackenzie Center, University of Alberta Hospital, 8440-112 St, Edmonton, AB, T6G 2B7, Canada. Daniel.oconnell@albertahealthservices.ca. LA - eng SI - ClinicalTrials.gov/NCT02268344 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20150530 PL - England TA - Trials JT - Trials JID - 101263253 SB - IM MH - Alberta MH - Biomechanical Phenomena MH - Clinical Protocols MH - Disability Evaluation MH - Double-Blind Method MH - Electric Stimulation Therapy/adverse effects/*methods MH - Electromyography MH - Head and Neck Neoplasms/pathology/*surgery MH - Humans MH - Intraoperative Care MH - Neck Dissection/adverse effects/*methods MH - Neurologic Examination MH - Pain Measurement MH - Pain, Postoperative/diagnosis/etiology/physiopathology/*prevention & control MH - Quality of Life MH - Research Design MH - Shoulder/*innervation MH - Shoulder Pain/diagnosis/etiology/physiopathology/*prevention & control MH - Time Factors MH - Treatment Outcome PMC - PMC4453046 EDAT- 2015/05/30 06:00 MHDA- 2016/03/02 06:00 PMCR- 2015/05/30 CRDT- 2015/05/30 06:00 PHST- 2014/08/31 00:00 [received] PHST- 2015/05/06 00:00 [accepted] PHST- 2015/05/30 06:00 [entrez] PHST- 2015/05/30 06:00 [pubmed] PHST- 2016/03/02 06:00 [medline] PHST- 2015/05/30 00:00 [pmc-release] AID - 10.1186/s13063-015-0745-7 [pii] AID - 745 [pii] AID - 10.1186/s13063-015-0745-7 [doi] PST - epublish SO - Trials. 2015 May 30;16:240. doi: 10.1186/s13063-015-0745-7.