Skip to main content
OpenTrials
Completed

NCT Number: NCT03545100

Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors

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.

Completed

Looking for future studies?

Notify Me

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

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

motor control therapy

Other

scapular muscle progressive resistive exercise(PRE)

Regular physical therapy

Other

transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE

Primary outcomes

  1. shoulder pain

    Time frame: 1 year

    Visual Analog Scale, the *total* range = 0-10

  2. shoulder joint range of motion

    Time frame: 1 year

    abduction measured by goniometer

  3. shoulder function

    Time frame: 1 year

    the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure for upper extremity function

  4. 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

Secondary outcomes

  1. surface electromyography (SEMG)

    Time frame: 1 year

    measure the muscle activities of the upper trapezius, middle trapezius, lower trapezius and serrates anterior

  2. quality of life C-30

    Time frame: 1 year

    European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30

  3. 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

  4. return to work

    Time frame: 1 year

    duration between return-to-work and operation

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2018
Registry last updated
Jul 16, 2020

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.

Published trials that share one or more normalized conditions with this study.