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

Primary Purpose

Oral Cancer

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
scapular-focused exercise
visual feedback
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Cancer focused on measuring Scapular-focused exercise, Scapular Dyskinesis, Spinal accessory nerve, Physical therapy, Electromyography, Visual feedback

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

EMG group

exercise group

Outcomes

Primary Outcome Measures

shoulder pain
Visual Analog Scale, total range=0-10, 0 means no pain and 10 means the obvious pain
shoulder joint range of motion
abduction measured by goniometer, total range: 0-180
scapular position
Modified Lateral Scapular Slide Test

Secondary Outcome Measures

quality of life C-30
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.
shoulder function
The Disabilities of the Arm, Shoulder and Hand (DASH) Score, total range: 0-100. Higher scores indicate greater disability.
muscle activity to perform arm movement
EMG activities measure the muscle activities of the upper trapezius, middle trapezius, and lower trapezius
maximal isometric muscle strength (MVIC)
measurement of MVIC of the upper trapezius, middle trapezius, and lower trapezius
EMG activities of maximal isometric muscle strength (MVIC)
measurement of surface EMG activities of the upper trapezius, middle trapezius, and lower trapezius during MVIC

Full Information

First Posted
July 16, 2020
Last Updated
July 29, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04476004
Brief Title
Effects of Electromyographic Visual Feedback for Spinal Accessory Nerve Dysfunction After Neck Dissection
Official Title
Effects of Electromyographic Visual Feedback for Spinal Accessory Nerve Dysfunction in Oral Cancer Survivors With Neck Dissection: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer
Keywords
Scapular-focused exercise, Scapular Dyskinesis, Spinal accessory nerve, Physical therapy, Electromyography, Visual feedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
EMG group
Arm Title
control group
Arm Type
Active Comparator
Arm Description
exercise group
Intervention Type
Other
Intervention Name(s)
scapular-focused exercise
Intervention Description
scapular-focused exercise
Intervention Type
Other
Intervention Name(s)
visual feedback
Intervention Description
EMG visual feedback
Primary Outcome Measure Information:
Title
shoulder pain
Description
Visual Analog Scale, total range=0-10, 0 means no pain and 10 means the obvious pain
Time Frame
0, 3 months
Title
shoulder joint range of motion
Description
abduction measured by goniometer, total range: 0-180
Time Frame
0, 3 months
Title
scapular position
Description
Modified Lateral Scapular Slide Test
Time Frame
0, 3 months
Secondary Outcome Measure Information:
Title
quality of life C-30
Description
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.
Time Frame
0, 3 months
Title
shoulder function
Description
The Disabilities of the Arm, Shoulder and Hand (DASH) Score, total range: 0-100. Higher scores indicate greater disability.
Time Frame
3 months
Title
muscle activity to perform arm movement
Description
EMG activities measure the muscle activities of the upper trapezius, middle trapezius, and lower trapezius
Time Frame
3 months
Title
maximal isometric muscle strength (MVIC)
Description
measurement of MVIC of the upper trapezius, middle trapezius, and lower trapezius
Time Frame
3 months
Title
EMG activities of maximal isometric muscle strength (MVIC)
Description
measurement of surface EMG activities of the upper trapezius, middle trapezius, and lower trapezius during MVIC
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yueh-Hsia Chen, Master
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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

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