FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/103063 [Registered on: 05/02/2026] Trial Registered Prospectively
Last Modified On: 04/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study in head and neck cancer patients to see whether using a simple nerve stimulator during neck surgery reduces shoulder problems 
Scientific Title of Study   Low cost nerve stimulator to reduce shoulder morbidity due to neck dissection in head and neck cancer a randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankur 
Designation  Mch senior resident 
Affiliation  AIIMS Mangalagiri 
Address  Room No. 414, 4th floor, surgical oncology department, AIIMS Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  6362336210  
Fax    
Email  ankurnov18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hemant Kumar Singh 
Designation  Assistant Professor 
Affiliation  AIIMS Mangalagiri 
Address  Room No. 416, Department Of Surgical Oncology, 4th Floor, OPD Building, AIIMS Mangalagiri, Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  8903306321  
Fax    
Email  hemant.surgicaloncology@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Hemant Kumar Singh 
Designation  Assistant Professor 
Affiliation  AIIMS Mangalagiri 
Address  Room No. 416, Department Of Surgical Oncology, 4th Floor, OPD Building, AIIMS Mangalagiri, Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  8903306321  
Fax    
Email  hemant.surgicaloncology@aiimsmangalagiri.edu.in  
 
Source of Monetary or Material Support  
AIIMS Mangalagiri, Mangalagiri, Guntur, ANDHRA PRADESH, 522503, India  
Dr Ankur surgical oncology Mch senior resident,Room No. 414, 4th floor, surgical oncology department, AIIMS Mangalagiri Guntur,Andhra Pradesh, 522503,India AIIMS Mangalagiri, 
 
Primary Sponsor  
Name  Dr Ankur 
Address  room no. 414. 4th floor , surgical oncology department, AIIMS Mangalagiri, guntur district, Andhra Pradesh 522503 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ankur  AIIMS Mangalagiri  Room number 414, surgical oncology department. Room number 004, neurology department. Operation theatre number 1, AIIMS Mangalagiri.
Guntur
ANDHRA PRADESH 		 6362336210

ankurnov18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government of India All India Institute of Medical Sciences Mangalagiri, Andhra Pradesh INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C760||Malignant neoplasm of head, face and neck,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  intraoperative Nerve stimulation group  Eligible patients will undergo standard preoperative evaluation, baseline clinical shoulder assessment using constant scoring, and preoperative EMG of the trapezius muscle. During surgery, neck dissection will be performed as per standard oncologic principles with visual identification of the spinal accessory nerve. In addition, a handheld low-cost nerve stimulator will be used to identify the nerve when a suspected nerve structure is encountered or before critical steps near the expected course of the nerve(near neck level II and V), stimulation will be applied starting at 0.5 mA and increased in 0.5 mA increments up to 2.0 mA (maximum 3.0 mA if no response), and visible or palpable trapezius contraction will be observed; EMG-based intraoperative monitoring will not be used. Surgical maneuvers will be modified based on responses to avoid nerve injury, and no muscle relaxant will be administered during the neck dissection phase. Postoperatively, patients will receive standard care and will undergo blinded clinical shoulder assessment at 1 week and 4 weeks, and repeat EMG at 4 weeks. 
Comparator Agent  standard care group  Eligible patients will undergo the same preoperative evaluation, baseline clinical shoulder assessment using constant scoring, and preoperative EMG. Neck dissection will be performed using standard surgical techniques based solely on visual identification and anatomical landmarks for spinal accessory nerve preservation, without the use of intraoperative nerve stimulation. Anesthesia and perioperative care will be as per routine practice. Postoperative management will be identical to the intervention arm, with blinded clinical shoulder assessment at 1 week and 4 weeks, and repeat EMG at 4 weeks for objective evaluation of nerve function. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients diagnosed with head and neck malignancies requiring unilateral or bilateral, selective or modified radical neck dissection involving levels II, and/or V
(example, oral cavity SCC, thyroid carcinoma etc)
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Ability to provide written informed consent.
Ability to understand and cooperate with clinical examinations and Electromyography study.
 
 
ExclusionCriteria 
Details  Patients with pre-existing dysfunction of the shoulder/SAN on the side(s) of planned neck dissection, as determined by preoperative clinical assessment and/or EMG.
More than 3cm node or with extranodal extension or clinically fixed level II and V
Previous neck dissection or surgery in the neck levels involving the Spinal Accessory, as this can significantly alter anatomy and baseline nerve function.
Prior radiotherapy to the neck involving the planned dissection levels, which can affect nerve health and recovery independently of surgical manipulation.
Known neuromuscular disorders (e.g., Myasthenia Gravis, ALS, peripheral neuropathy not related to HNC or its treatment) that could affect the targeted nerves or muscles
Patients with cognitive impairment precluding cooperation with clinical assessment or providing informed consent.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Postoperative SAN dysfunction with respect to electrophysiological parameters of Postoperative EMG [using tsuji score (which includes Fibrillation, PSW score, MUAP characteristics and interference pattern)], compared to preoperative baseline.
 		 at 4 weeks postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome will be measure of shoulder dysfunction, given by constant score which include pain, disturbance in activities of daily living, limitation in range of motion, and power.  This will be measured at 1 week postoperatively and at 4 weeks postoperatively.
 
Functional Assessment Measures:
Shoulder shrug strength (0-5 scale)
Scapular winging assessment (present/absent)
Scapular dyskinesis evaluation (present/absent) 		 This will be checked at 1 week postoperatively and at 4 weeks postoperatively. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (ankurnov18@gmail.com).

  6. For how long will this data be available start date provided 01-06-2028 and end date provided 01-06-2031?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The primary purpose of this study is to determine whether the routine intraoperative use of a low-cost handheld nerve stimulator during neck dissection reduces postoperative spinal accessory nerve–related shoulder dysfunction compared with standard visual nerve identification alone. The study hypothesizes that intraoperative nerve stimulation with observation of muscle contraction will improve identification and preservation of the spinal accessory nerve, thereby resulting in significantly better postoperative shoulder function and electrophysiological nerve outcomes than conventional surgery without stimulation. 
Close