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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.

ABSTRACT: Shoulder dysfunction is common after neck dissection for head and neck cancer (HNC). Brief electrical stimulation (BES) is a novel technique that has been shown to enhance neuronal regeneration after nerve injury by modulating the brain-derived neurotrophic growth factor (BDNF) pathways. The objective of this study was to evaluate the effect of BES on postoperative shoulder function following oncologic neck dissection.Adult participants with a new diagnosis of HNC undergoing Level IIb +/- V neck dissection were recruited. Those in the treatment group received intraoperative BES applied to the spinal accessory nerve (SAN) after completion of neck dissection for 60 min of continuous 20 Hz stimulation at 3-5 V of 0.1 msec balanced biphasic pulses, while those in the control group received no stimulation (NS). The primary outcome measured was the Constant-Murley Shoulder (CMS) Score, comparing changes from baseline to 12 months post-neck dissection. Secondary outcomes included the change in the Neck Dissection Impairment Index (?NDII) score and the change in compound muscle action potential amplitude (?CMAP) over the same period.Fifty-four patients were randomized to the treatment or control group with a 1:1 allocation scheme. No differences in demographics, tumor characteristics, or neck dissection types were found between groups. Significantly lower ?CMS scores were observed in the BES group at 12 months, indicating better preservation of shoulder function (p?=?0.007). Only four in the BES group compared to 17 patients in the NS groups saw decreases greater than the minimally important clinical difference (MICD) of the CMS (p?=?0.023). However, NDII scores (p?=?0.089) and CMAP amplitudes (p?=?0.067) between the groups did not reach statistical significance at 12 months. BES participants with Level IIb?+?V neck dissections had significantly better ?CMS and ?CMAP scores at 12 months (p?=?0.048 and p?=?0.025, respectively).Application of BES to the SAN may help reduce impaired shoulder function in patients undergoing oncologic neck dissection, and may be considered a viable adjunct to functional rehabilitation therapies.Clinicaltrials.gov ( NCT02268344 , October 17, 2014).

SUBMITTER: Barber B

PROVIDER: S-EPMC5781293 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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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.

Barber Brittany B Seikaly Hadi H Ming Chan K K Beaudry Rhys R Rychlik Shannon S Olson Jaret J Curran Matthew M Dziegielewski Peter P Biron Vincent V Harris Jeffrey J McNeely Margaret M O'Connell Daniel D

Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale 20180123 1

<h4>Background</h4>Shoulder dysfunction is common after neck dissection for head and neck cancer (HNC). Brief electrical stimulation (BES) is a novel technique that has been shown to enhance neuronal regeneration after nerve injury by modulating the brain-derived neurotrophic growth factor (BDNF) pathways. The objective of this study was to evaluate the effect of BES on postoperative shoulder function following oncologic neck dissection.<h4>Methods</h4>Adult participants with a new diagnosis of ...[more]

PMID: 29361981

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Project description:BackgroundShoulder 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/designThis 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.DiscussionThe 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 registrationNCT02268344: 17 October 2014.

Project description:Intraoperative magnetic resonance imaging (iMRI) is a tool now commonly used in neurosurgery. Safe and reliable patient care in this (or any other) operating room setting depends on an environment, where electrical noise (EN) does not interfere with the operation of the electronic monitoring or imaging equipment. In this investigation, we evaluated the EN generated by the iMRI system and the anesthesia patient monitor used at this institution that impacts the performance of these two devices.We measured the EN generated by our iMRI-compatible anesthesia patient monitor as detected by the EN analysis algorithm in our iMRI system. We measured the EN generated by our iMRI system during scanning as detected in the electrocardiogram (ECG) waveform of our patient monitor. We analyzed the effects on EN reduction and signal quality of the ECG noise filters provided in our iMRI-compatible anesthesia patient monitor.Our patient monitor generated EN that was detectable by the iMRI EN analysis algorithm; however, this interference was within the iMRI manufacturer's acceptable limits for an iMRI scan (<10% more than background system-level noise). In the clinical case analyzed, the iMRI generated a narrow-band low-frequency (20 Hz) relatively high-energy EN that interfered with the ECG signal of our patient monitor during an iMRI scan. This EN was correlated with the acoustic noise from the iMRI system during the scan and was associated with the radio frequency (RF) and magnetic gradient pulsations of the iMRI system. The integrity of the ECG waveform was nearly entirely lost during a scan. The filters of the ECG monitor diminished but did not entirely eliminate this 20 Hz interference. We found that the filters alter the morphology of the ECG signal, which may make it difficult to identify clinically relevant ECG changes.The EN generated by our anesthesia patient monitor is within acceptable limits for the iMRI system. The iMRI generates EN which renders the ECG unreadable in the most commonly used filter mode. The monitor's filters diminish this noise but also alter the morphology of the ECG waveform. The anesthesiologist must be cognizant of these technical compromises and recognize that adjusting the ECG filters on the monitor is required to obtain a useful ECG signal for patient monitoring during the iMRI scan but that the diagnostic value of the ECG will be reduced.

Dataset Information

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.

Publications

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.

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