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Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors

Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03545100
Enrollment
60
Registered
2018-06-04
Start date
2018-06-01
Completion date
2020-02-06
Last updated
2020-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cancer

Keywords

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

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).

Interventions

OTHERmotor control therapy

scapular muscle progressive resistive exercise(PRE)

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

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
shoulder joint range of motion1 yearabduction measured by goniometer
shoulder function1 yearthe Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure for upper extremity function
maximal isometric muscle strength1 yearmeasurement for the upper trapezius, middle trapezius, lower trapezius and serrates anterior at the moment of SEMG
shoulder pain1 yearVisual Analog Scale, the \*total\* range = 0-10

Secondary

MeasureTime frameDescription
surface electromyography (SEMG)1 yearmeasure the muscle activities of the upper trapezius, middle trapezius, lower trapezius and serrates anterior
quality of life C-301 yearEuropean Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30
quality of life H&N351 yearEuropean Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35
return to work1 yearduration between return-to-work and operation

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026