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

Oral Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04476004
• Other study ID #: 201901788A3
• Status: Completed
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: October 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mouth Neoplasms
• Oral Cancer

Intervention

Other:
• scapular-focused exercise
scapular-focused exercise
• visual feedback
EMG visual feedback

Locations

Country	Name	City	State
Taiwan	Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	shoulder pain	Visual Analog Scale, total range=0-10, 0 means no pain and 10 means the obvious pain	0, 3 months
Primary	shoulder joint range of motion	abduction measured by goniometer, total range: 0-180	0, 3 months
Primary	scapular position	Modified Lateral Scapular Slide Test	0, 3 months
Secondary	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.	0, 3 months
Secondary	shoulder function	The Disabilities of the Arm, Shoulder and Hand (DASH) Score, total range: 0-100. Higher scores indicate greater disability.	3 months
Secondary	muscle activity to perform arm movement	EMG activities measure the muscle activities of the upper trapezius, middle trapezius, and lower trapezius	3 months
Secondary	maximal isometric muscle strength (MVIC)	measurement of MVIC of the upper trapezius, middle trapezius, and lower trapezius	3 months
Secondary	EMG activities of maximal isometric muscle strength (MVIC)	measurement of surface EMG activities of the upper trapezius, middle trapezius, and lower trapezius during MVIC	3 months