Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors

Oral Cancer Clinical Trial

Official title:

Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545100
• Other study ID #: 201800026A3
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: February 6, 2020

Study information

• Verified date: August 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 6, 2020
• Est. primary completion date: February 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lip Neoplasms
• Mouth Neoplasms
• Oral Cancer

Intervention

Other:
• motor control therapy
scapular muscle progressive resistive exercise(PRE)
• regular physical therapy
transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE

Locations

Country	Name	City	State
Taiwan	Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (41)

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	shoulder pain	Visual Analog Scale, the *total* range = 0-10	1 year
Primary	shoulder joint range of motion	abduction measured by goniometer	1 year
Primary	shoulder function	the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure for upper extremity function	1 year
Primary	maximal isometric muscle strength	measurement for the upper trapezius, middle trapezius, lower trapezius and serrates anterior at the moment of SEMG	1 year
Secondary	surface electromyography (SEMG)	measure the muscle activities of the upper trapezius, middle trapezius, lower trapezius and serrates anterior	1 year
Secondary	quality of life C-30	European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30	1 year
Secondary	quality of life H&N35	European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35	1 year
Secondary	return to work	duration between return-to-work and operation	1 year