Clinical trial NCT03545100: Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors
Official title: Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Cancer
Keywords: oral cancer
shoulder dysfunction
quality of life
motor control
strengthening exercise
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: shoulder pain
timeFrame: 1 year
measure: shoulder joint range of motion
timeFrame: 1 year
measure: shoulder function
timeFrame: 1 year
measure: maximal isometric muscle strength
timeFrame: 1 year
Secondary outcomes:
measure: surface electromyography (SEMG)
timeFrame: 1 year
measure: quality of life C-30
timeFrame: 1 year
measure: quality of life H&N35
timeFrame: 1 year
measure: return to work
timeFrame: 1 year
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yueh-Hsia Chen, Master
role: PRINCIPAL_INVESTIGATOR
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