Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors

NCT03545100 | Completed

• 1 other identifier: 201800026A3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Cancer

Keywords

oral cancer; shoulder dysfunction; quality of life; motor control; strengthening exercise

Outcome Measures

Primary Outcomes (4)

• shoulder pain

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

  1 year

• shoulder joint range of motion

  abduction measured by goniometer

  1 year

• shoulder function

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

  1 year

• maximal isometric muscle strength

  measurement for the upper trapezius, middle trapezius, lower trapezius and serrates anterior at the moment of SEMG

  1 year

Secondary Outcomes (4)

• surface electromyography (SEMG)

  1 year

• quality of life C-30

  1 year

• quality of life H&N35

  1 year

• return to work

  1 year

Study Arms (2)

experimental group

EXPERIMENTAL

motor control therapy

Other: motor control therapy; Other: regular physical therapy

control group

ACTIVE COMPARATOR

regular physical therapy

Other: regular physical therapy

Interventions

motor control therapy OTHER

scapular muscle progressive resistive exercise(PRE)

experimental group

regular physical therapy OTHER

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

control group; experimental group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

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

Taoyuan District, 333, Taiwan

Location

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MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Yueh-Hsia Chen, Master

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 4, 2018
• Study Start: June 1, 2018
• Primary Completion: February 6, 2020
• Study Completion: February 6, 2020
• Last Updated: July 16, 2020

Record last verified: 2019-08

Locations

TW (1)