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A study in head and neck cancer patients to see whether using a simple nerve stimulator during neck surgery reduces shoulder problems

Low cost nerve stimulator to reduce shoulder morbidity due to neck dissection in head and neck cancer a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103063
Enrollment
70
Registered
2026-02-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C760- Malignant neoplasm of head, face and neck

Interventions

Intervention1: intraoperative Nerve stimulation group: Eligible patients will undergo standard preoperative evaluation, baseline clinical shoulder assessment using constant scoring, and preoperative E
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 dissecti

Sponsors

Dr Ankur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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. Timepoint: at 4 weeks postoperatively

Secondary

MeasureTime frame
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.Timepoint: 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)Timepoint: This will be checked at 1 week postoperatively and at 4 weeks postoperatively.

Countries

India

Contacts

Public ContactDr Hemant Kumar Singh

AIIMS Mangalagiri

hemant.surgicaloncology@aiimsmangalagiri.edu.in8903306321

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026