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Completed

NCT Number: NCT04476004

Effects of Electromyographic Visual Feedback for Spinal Accessory Nerve Dysfunction After Neck Dissection

Patients with head and neck cancer and undergo neck dissection often suffer from spinal accessory nerve dysfunction (e.g. shoulder droop, shoulder pain, and decreased active range of motion (AROM) of the shoulder joint and scapular muscle strength), even the spinal accessory nerve is preserved during surgery. Abnormal muscle activities of scapular muscles, including upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), serratus anterior (SA) and rhomboid were reported in subsequent research articles. Particularly for the trapezius muscle, the decreased amplitudes were observed even after 9 months of neck dissection. It has been reported that conscious correction of scapular orientation during arm movement could increase trapezius muscle activities, and motor control training could change scapular kinematic such as increased posterior tilt and upward rotation during arm movement.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

Patients with head and neck cancer and undergo neck dissection often suffer from spinal accessory nerve dysfunction (e.g. shoulder droop, shoulder pain, and decreased active range of motion (AROM) of the shoulder joint and scapular muscle strength), even the spinal accessory nerve is preserved during surgery. Abnormal muscle activities of scapular muscles, including upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), serratus anterior (SA) and rhomboid were reported in subsequent research articles. Particularly for the trapezius muscle, the decreased amplitudes were observed even after 9 months of neck dissection. It has been reported that conscious correction of scapular orientation during arm movement could increase trapezius muscle activities, and motor control training could change scapular kinematic such as increased posterior tilt and upward rotation during arm movement.

The aim of this study is to explore the effects of electromyographic (EMG) visual feedback on scapular muscle activities and strength in oral cancer survivors with spinal accessory nerve dysfunction. Investigators will recruit 60 newly diagnosed oral cancer subjects through the plastic surgeon's referral from January 2020 to February 2021. The participants will be randomized separated into experimental or control group. Each group would receive regular physical therapy for shoulder function (e.g. transcutaneous electrical stimulation, shoulder joint range of motion exercise) and scapular-focused exercise. EMG visual feedback would be combined with scapular-focused exercise.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newly diagnosed oral cancer subjects with neck dissection
  • age between 20 and 65 years
  • having the clinical signs of neck-dissection related shoulder dysfunction (e.g. shoulder droop, limited AROM of shoulder abduction, and insufficient muscle strength of shoulder abduction to against gravity)

Exclusion criteria

  • were pregnant or breastfeeding
  • had distant metastasis or recurrence
  • were unable to communicate or comprehend the questionnaires
  • had a history of shoulder dysfunction before neck dissection (e.g. shoulder pain, tendinitis, tendon rupture, shoulder capsulitis, or neuropathy)
  • had any disorder that could influence movement performance
  • bilateral neck dissection

Treatment and study plan

scapular-focused exercise

Other

scapular-focused exercise

Visual feedback

Other

EMG visual feedback

Primary outcomes

  1. shoulder pain

    Time frame: 0, 3 months

    Visual Analog Scale, total range=0-10, 0 means no pain and 10 means the obvious pain

  2. shoulder joint range of motion

    Time frame: 0, 3 months

    abduction measured by goniometer, total range: 0-180

  3. scapular position

    Time frame: 0, 3 months

    Modified Lateral Scapular Slide Test

Secondary outcomes

  1. quality of life C-30

    Time frame: 0, 3 months

    European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30, total range= 0-100. A higher score on the functional scale or global health scale represents a higher level of functioning or quality of life.

  2. shoulder function

    Time frame: 3 months

    The Disabilities of the Arm, Shoulder and Hand (DASH) Score, total range: 0-100. Higher scores indicate greater disability.

  3. muscle activity to perform arm movement

    Time frame: 3 months

    EMG activities measure the muscle activities of the upper trapezius, middle trapezius, and lower trapezius

  4. maximal isometric muscle strength (MVIC)

    Time frame: 3 months

    measurement of MVIC of the upper trapezius, middle trapezius, and lower trapezius

  5. EMG activities of maximal isometric muscle strength (MVIC)

    Time frame: 3 months

    measurement of surface EMG activities of the upper trapezius, middle trapezius, and lower trapezius during MVIC

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Effects of Electromyographic Visual Feedback for Spinal Accessory Nerve Dysfunction in Oral Cancer Survivors With Neck Dissection: a Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 17, 2020
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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