Study to translate self reported shoulder dysfunction after surgery in Head Neck cancer patients
- Conditions
- Other disorders of the nervous system,
- Registration Number
- CTRI/2019/08/020977
- Lead Sponsor
- NA
- Brief Summary
Neck dissection plays an integral part in the surgical management of head and neck cancers. Although neck dissection techniques were described as early as the eighteenth century, a systematic approach to it was described by George Washington Crile in 1906.1 The technique of neck dissection has undergone major transformations over the years, from Radical neck dissection to a Selective neck dissection.2 Neck dissection is a time tested procedure, however it is still associated with significant complications. Injury to the spinal accessory nerve results in the Painful Shoulder Syndrome or the 11th Nerve Syndrome. 3 The incidence of painful shoulder syndrome varies between the various types of neck dissection. It is highest in radical neck dissection (79%) and modified radical neck dissection (65%). 4 A lower incidence of Shoulder dysfunction syndrome has been seen in selective neck dissection. 5 Shoulder dysfunction in Selective neck dissection is primarily due to handling of the spinal accessory and thermal injury due to electrocautery, some authors therefore avoid dissection of Level IIb nodes in clinically N0 neck.5 Various scales such as self-report Flexilevel scale of shoulder
function, constant shoulder score etc., are used to assess shoulder dysfunction in the post-operative period. 6, 7 Electromyography(EMG) is an objective way to evaluate shoulder dysfunction, and it has been shown to be a sensitive and painless method.8 However EMG may not be available at all times and therefore there needs to be an alternative way to detect shoulder dysfunction. NDII and Constant Morley’s scales are widely used to subjectively assess degree of shoulder dysfunction. Constant’s score was devised by Christopher Constant for standardisation of shoulder function assessment, it was revised and modified in 2008. NDII was devised as a health-related quality-of-life (QOL) instrument for patients following neck dissection and to identify the factors that affect QOL following neck dissection in 2002 by Rodney Taylor, it is approved by the American association of Shoulder and elbow surgeons. In this study, we aim to translate the constant shoulder scale and NDII and validate these scales. Early confirmation of shoulder dysfunction would aid to initiate early physical therapy for the patients which would reduce the associated morbidity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 70
- Patients of head neck cancer who have undergone some form of neck dissection 2.
- Loco-regionally controlled 3.
- Age 18-75 years 4.
- Literate patients – patients who have studied high school and can read, write and understand either Hindi or Marathi.
- ECOG 0, 1, 2 performance status.
- Age < 18 years or >75 years 2.
- Illiterate patients 3.
- ECOG status >2 4.
- Patients undergoing only level VI neck dissection.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To translate shoulder dysfunction specific questionnaires namely Constant shoulder scale and Neck Dissection Impairment Index into Hindi and Marathi At the start of the study
- Secondary Outcome Measures
Name Time Method 1. To generate psychometric data regarding the questionnaires’ reliability and validity when used in the Indian population 2. To compare the ease of administration between the two questionnaires i.e. Constant Shoulder Scale and neck dissection Impairment Index.
Trial Locations
- Locations (1)
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Tata Memorial Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr Gouri PantvaidyaPrincipal investigator9833971155docgouri@gmail.com