Shoulder PainESSANNCT02268344
Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection
A study testing Grass SD9 Stimulator in people with Shoulder Pain and Head Neck Cancer, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Shoulder Pain, Head Neck Cancer
- What is being tested?
- Grass SD9 Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- 6 Oct 2014to 6 Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection (ESSAN): a Double-blinded, Randomized Control Trial
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.
Read the 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 stimulation continuously at 20 Hz at an intensity of 1.5 times the motor threshold for 60 minutes, or 2) sham/no 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.
- Conditions
- Shoulder Pain, Head Neck Cancer
- Being tested
- Grass SD9 Stimulator
- Keywords
- nerve regeneration, spinal accessory nerve, shoulder function, head neck cancer, electrical stimulation
- Medical subject headings
- Shoulder Pain, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grass SD9 StimulatorDevice
Also called Electrical Stimulation (ES)
Electrical stimulation will be applied to the nerve using the Grass SD9 Stimulator at a frequency of 20Hz, 10-15V, for 60 minutes during the surgery. This will occur after the neck dissection has been completed, and the remainder of the surgery will continue during stimulation. The stimulation will be applied using the Grass SD9 Stimulator and the current will be conducted to the nerve using a sterile wire electrode that will be encircled around the nerve at its most proximally-exposed portion (skull base). The wire will be removed after 60 minutes of stimulation has been applied.
| Study group | Role | What they receive |
|---|---|---|
| Grass SD9 Stimulator | Active comparator | Brief intraoperative electrical stimulation of the spinal accessory nerve (ESSAN) continuously at 20 Hz, 10-15V for 60 minutes immediately following neck dissection. Receives: Device: Grass SD9 Stimulator |
| No Stimulation | No intervention | No stimulation will be performed in this group, and patients will simply have the neck dissection as planned. No sham stimulation is required, as all outcome measures are performed by individuals not present in the operating room, and therefore, blinded to the treatment arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months postoperatively
Secondary outcomes (5)
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.
Measured: 6 months postoperatively
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.
Measured: 6 months postoperatively
Nerve Conduction Studies (NCS)
This will include conduction velocity and amplitude as it relates to nerve injury during oncologic neck dissection.
Measured: 6 months months postoperatively
Electromyographic (EMG) studies
This will pertain to electrophysiologic thresholds necessary to evoke a motor response from the trapezius and sternocleidomastoid, to evaluate nerve function.
Measured: 6 months postoperatively
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.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study start6 Oct 2014
- Primary completion6 Jun 2015
- Study completion6 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Brief intraoperative electrical stimulation of the spinal accessory nerve (ESSAN) continuously at 20 Hz, 10-15V for 60 minutes immediately following neck dissection
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brittany Barber, MD, Study chair, Division of Otolaryngology-Head & Neck Surgery, University of AlbertaDaniel O'Connell, MD MSc FRCSC, Principal investigator, Division of Otolaryngology-Head & Neck Surgery, University of AlbertaHadi Seikaly, MD MAL FRCSC, Study director, Division of Otolaryngology-Head & Neck Surgery, University of AlbertaMing Chan, MD FRCPC, Study director, Department of Physical Rehabilitation and Medicine, University of AlbertaMargaret McNeely, PT PhD, Study director, Faculty of Rehabilitation Medicine, University of AlbertaJeffrey Harris, MD MHA FRCSC, Study chair, Division of Otolaryngology-Head & Neck Surgery, University of AlbertaJaret Olson, MD FRCSC, Study chair, Division of Plastic Surgery, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268344
- Sponsor's protocol ID
- pro00046671
- Acronym
- ESSAN
- Status last verified
- May 2020
- First submitted
- 10 Oct 2014
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29361981Barber B, McNeely M, Chan KM, Beaudry R, Olson J, Harris J, Seikaly H, O'Connell D. Intraoperative brief electrical stimulation (BES) for prevention of shoulder dysfunction after oncologic neck dissection: study protocol for a randomized controlled trial. Trials. 2015 May 30;16:240. doi: 10.1186/s13063-015-0745-7.
PubMed 26021563
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection (ESSAN): a Double-blinded, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02268344
- Acronym / sponsor ID
- ESSAN / pro00046671
- Conditions
- Shoulder Pain, Head Neck Cancer
- Keywords
- nerve regeneration, spinal accessory nerve, shoulder function, head neck cancer, electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 6 Oct 2014 (actual)
- Primary completion
- 6 Jun 2015 (actual)
- Study completion
- 6 Jun 2015 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 stimulation continuously at 20 Hz at an intensity of 1.5 times the motor threshold for 60 minutes, or 2) sham/no 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Brief intraoperative electrical stimulation of the spinal accessory nerve (ESSAN) continuously at 20 Hz, 10-15V for 60 minutes immediately following neck dissection
| Arm | Type | Receives |
|---|---|---|
| Grass SD9 Stimulator | Active comparator | Device: Grass SD9 StimulatorBrief intraoperative electrical stimulation of the spinal accessory nerve (ESSAN) continuously at 20 Hz, 10-15V for 60 minutes immediately following neck dissection. |
| No Stimulation | No intervention | –No stimulation will be performed in this group, and patients will simply have the neck dissection as planned. No sham stimulation is required, as all outcome measures are performed by individuals not present in the operating room, and therefore, blinded to the treatment arm. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grass SD9 StimulatorAlso: Electrical Stimulation (ES)Electrical stimulation will be applied to the nerve using the Grass SD9 Stimulator at a frequency of 20Hz, 10-15V, for 60 minutes during the surgery. This will occur after the neck dissection has been completed, and the remainder of the surgery will continue during stimulation. The stimulation will be applied using the Grass SD9 Stimulator and the current will be conducted to the nerve using a sterile wire electrode that will be encircled around the nerve at its most proximally-exposed portion (skull base). The wire will be removed after 60 minutes of stimulation has been applied. | Device | Grass SD9 Stimulator |
Primary outcome
Constant-Murley Score
Time frame: 6 months postoperatively
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.
5 secondary outcomes
Oxford Shoulder Score (OSS)
Time frame: 6 months postoperatively
Neck Dissection Impairment Index (NDII)
Time frame: 6 months postoperatively
Nerve Conduction Studies (NCS)
Time frame: 6 months months postoperatively
Electromyographic (EMG) studies
Time frame: 6 months postoperatively
University of Washington Quality of Life (UW-QOL) questionnaire
Time frame: 6 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Background: PubMed 29361981Barber 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.
- Derived from this study: PubMed 26021563Barber B, McNeely M, Chan KM, Beaudry R, Olson J, Harris J, Seikaly H, O'Connell D. Intraoperative brief electrical stimulation (BES) for prevention of shoulder dysfunction after oncologic neck dissection: study protocol for a randomized controlled trial. Trials. 2015 May 30;16:240. doi: 10.1186/s13063-015-0745-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brittany Barber, MD study chair
Division of Otolaryngology-Head & Neck Surgery, University of Alberta
Daniel O'Connell, MD MSc FRCSC principal investigator
Division of Otolaryngology-Head & Neck Surgery, University of Alberta
Hadi Seikaly, MD MAL FRCSC study director
Division of Otolaryngology-Head & Neck Surgery, University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grass SD9 Stimulator in people with Shoulder Pain and Head Neck Cancer, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant-Murley Score (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02268344, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.