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Clinical Trials/NCT04476004
NCT04476004CompletedNot Applicable

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

Chang Gung Memorial Hospital2 sites in 1 country24 target enrollmentStarted: January 2, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
24
Locations
2
Primary Endpoint
shoulder pain

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

shoulder pain

Time Frame: 0, 3 months

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

shoulder joint range of motion

Time Frame: 0, 3 months

abduction measured by goniometer, total range: 0-180

scapular position

Time Frame: 0, 3 months

Modified Lateral Scapular Slide Test

Secondary Outcomes

  • muscle activity to perform arm movement(3 months)
  • maximal isometric muscle strength (MVIC)(3 months)
  • shoulder function(3 months)
  • EMG activities of maximal isometric muscle strength (MVIC)(3 months)
  • quality of life C-30(0, 3 months)

Investigators

Sponsor
Chang Gung Memorial Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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