Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors

July 14, 2020 updated by: Chang Gung Memorial Hospital
Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. The probability of shoulder dysfunction after neck dissection is as high as 70%. Rehabilitation effects on shoulder function for head and neck survivors are needed for further studied.The purpose of this randomized clinical trial is to explore the effects of rehabilitation for shoulder function in oral cancer survivors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. The probability of shoulder dysfunction after neck dissection is as high as 70%. Rehabilitation effects on shoulder function for head and neck survivors are needed for further studied.

The purpose of this randomized clinical trial is to explore the effects of rehabilitation for shoulder function in oral cancer survivors. We will recruit 60 newly diagnosed oral cancer subjects through the plastic surgeon's referral from April 2018 to March 2020. The participants will be randomized separated into experimental or control group. Each group would receive regular physical therapy for shoulder function (i.e., transcutaneous electrical stimulation, shoulder joint range of motion exercise, scapular muscle strengthening training). Experimental group would be supplemented by motor control therapy targeting the scapular muscle progressive resistance exercise (exercise plus manual therapy).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willing to sign the inform consent
  • Sufficiently communicate in the Chinese language
  • Be able to follow instructions
  • Newly diagnosed oral cancer
  • Spinal accessory shoulder dysfunction

Exclusion Criteria:

  • Pregnant or breast-feeding woman
  • Cognitively impaired
  • Central nervous disease
  • Distant metastasis or recurrence
  • A history of shoulder pain or known shoulder pathology
  • Unable to communicate or comprehend the questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
motor control therapy
Other: motor control therapy
scapular muscle progressive resistive exercise(PRE)
Other: regular physical therapy
transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE
Active Comparator: control group
regular physical therapy
Other: regular physical therapy
transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shoulder pain
Time Frame: 1 year
Visual Analog Scale, the *total* range = 0-10
1 year
shoulder joint range of motion
Time Frame: 1 year
abduction measured by goniometer
1 year
shoulder function
Time Frame: 1 year
the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure for upper extremity function
1 year
maximal isometric muscle strength
Time Frame: 1 year
measurement for the upper trapezius, middle trapezius, lower trapezius and serrates anterior at the moment of SEMG
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surface electromyography (SEMG)
Time Frame: 1 year
measure the muscle activities of the upper trapezius, middle trapezius, lower trapezius and serrates anterior
1 year
quality of life C-30
Time Frame: 1 year
European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30
1 year
quality of life H&N35
Time Frame: 1 year
European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35
1 year
return to work
Time Frame: 1 year
duration between return-to-work and operation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

February 6, 2020

Study Completion (Actual)

February 6, 2020

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (Actual)

June 4, 2018

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201800026A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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