Safety Study of Musculoskeletal Ultrasonographic to Assess Disabilities Arm of Head and Neck Cancer Patient

Study Overview
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Brief Summary
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The investigators suppose: 1. SND may cause damage to the soft tissue around shoulder girdle. 2. The soft tissue injury may be related with the order of severity of wing scapula and duration after SND. The aims of this study are: 1. To assess the functional disabilities of shoulder and upper extremity in different time period after SND. 2. To evaluate the soft tissue lesion of shoulder with soft tissue ultrasonography to prove our hypothesis. This study is a two years, prospective, cross-section study. The investigators will enroll 80 HNC post SND within 3months, >3- 6months,> 6months -1 year, more than 1 year as four different groups, 20 patient in each group.

Detailed Description
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Lymph node metastasis is one the most important prognostic-factors in head and neck cancer(HNC). Radical neck dissection (RND) has been the standard surgical method for HNC with neck lymph nodes metastasis in past decades. This operation includes removal of the sternocleidomastoid muscle (SCM), internal jugular vein (IJV) all cervical lymph nodes on one side and spinal accessory nerve (SAN), leading to significant ipsilateral shoulder syndrome caused by SAN dysfunction and impact quality of life. Despite most clinics prefer to use the nerve-sparing selective neck dissection (SND) for patient with N0 or N1 nodal disease today, shoulder disability and pain were still reported from 31% to 40% after this procedure. However, most previous studies evaluated the shoulder disability only by functional evaluation, range of motion, and questionnaire. The short and long term adverse effect to soft tissue around shoulder girdle after SND has not been reported. The investigators suppose: 1. SND may cause damage to the soft tissue around shoulder girdle. 2. The soft tissue injury may be related with the order of severity of wing scapula and duration after SND. The aims of this study are: 1. To assess the functional disabilities of shoulder and upper extremity in different time period after SND. 2. To evaluate the soft tissue lesion of shoulder with soft tissue ultrasonography to prove our hypothesis. This study is a two years, prospective, cross-section study. The investigators will enroll 80 HNC post SND within 3months, >3- 6months,> 6months -1 year, more than 1 year as four different groups, 20 patient in each group. Evaluate the soft tissue of shoulder girdle with musculoskeletal ultrasonography and elastography, compare the finding in each group and the range of motion of their shoulder, the severity of wing scapula, visual pain analog scale and the score of The Disability of Arm, Shoulder and Hand (DASH) questionnaire. Statistical analysis will perform by SPSS software (SPSS V 20. International Business Machines. USA).

Official Title
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Musculoskeletal Ultrasonographic Assessment for the Soft Tissue Injury of Ipsilateral Shoulder of Head and Neck Cancer Patient Following Selective Neck Dissection

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Other: ultrasonography and elastography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: head and neck cancer by Never-Sparing Selective Neck dissection, SND, the skin condition is stable, there is no wound, infection or inflammation metastasis. Exclusion Criteria: (1) in head and neck cancer before surgery and there had been other nerves, bones, muscles, tendons, resulting in lesions of the shoulder pain disorders or a history of activity. (2) severe cognitive function can not meet the examiner. (3) age less than 20 years of age or over 65 years of age.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| post SND within 3 months<br>20 Head and Neck Cancer(HNC) complicated with ipsilateral shoulder disability post SND within 3 months, evaluate the soft tissue of shoulder girdle with musculoskeletal ultrasonography and elastography, compare the finding in each group and the range of motion of their shoulder, the severity of wing scapula, visual pain analog scale and the score of The Disability of Arm, Shoulder and Hand | Other: ultrasonography and elastography<br>* Evaluate the soft tissue of shoulder girdle with musculoskeletal ultrasonography and elastography, compare the finding in each group and the range of motion of their shoulder, the severity of wing scapula, visual pain analog scale and the score of The Disability of Arm, Shoulder and Hand<br>|
| post SND within >3- 6months<br>20 Head and Neck Cancer(HNC) complicated with ipsilateral shoulder disability post SND within >3- 6months, evaluate the soft tissue of shoulder girdle with musculoskeletal ultrasonography and elastography, compare the finding in each group and the range of motion of their shoulder, the severity of wing scapula, visual pain analog scale and the score of The Disability of Arm, Shoulder and Hand | Other: ultrasonography and elastography<br>* Evaluate the soft tissue of shoulder girdle with musculoskeletal ultrasonography and elastography, compare the finding in each group and the range of motion of their shoulder, the severity of wing scapula, visual pain analog scale and the score of The Disability of Arm, Shoulder and Hand<br>|
| post SND within 6 months -1 year<br>20 Head and Neck Cancer(HNC) complicated with ipsilateral shoulder disability post SND within 6 months -1 year, evaluate the soft tissue of shoulder girdle with musculoskeletal ultrasonography and elastography, compare the finding in each group and the range of motion of their shoulder, the severity of wing scapula, visual pain analog scale and the score of The Disability of Arm, Shoulder and Hand | Other: ultrasonography and elastography<br>* Evaluate the soft tissue of shoulder girdle with musculoskeletal ultrasonography and elastography, compare the finding in each group and the range of motion of their shoulder, the severity of wing scapula, visual pain analog scale and the score of The Disability of Arm, Shoulder and Hand<br>|
| post SND within more than 1 year<br>20 Head and Neck Cancer(HNC) complicated with ipsilateral shoulder disability post SND within more than 1 year, evaluate the soft tissue of shoulder girdle with musculoskeletal ultrasonography and elastography, compare the finding in each group and the range of motion of their shoulder, the severity of wing scapula, visual pain analog scale and the score of The Disability of Arm, Shoulder and Hand | Other: ultrasonography and elastography<br>* Evaluate the soft tissue of shoulder girdle with musculoskeletal ultrasonography and elastography, compare the finding in each group and the range of motion of their shoulder, the severity of wing scapula, visual pain analog scale and the score of The Disability of Arm, Shoulder and Hand<br>|
| without shoulder disability<br>20 Head and Neck Cancer(HNC) post SND without shoulder complication at the control group, evaluate the soft tissue of shoulder girdle with musculoskeletal ultrasonography and elastography, compare the finding in each group and the range of motion of their shoulder, the severity of wing scapula, visual pain analog scale and the score of The Disability of Arm, Shoulder and Hand | Other: ultrasonography and elastography<br>* Evaluate the soft tissue of shoulder girdle with musculoskeletal ultrasonography and elastography, compare the finding in each group and the range of motion of their shoulder, the severity of wing scapula, visual pain analog scale and the score of The Disability of Arm, Shoulder and Hand<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-Item findings of musculoskeletal ultrasonography and elastography |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion | Each specific joint has a normal range of motion that is expressed in degrees.Devices to measure range of motion in the joints of the shoulder include the goniometer which use a stationary arm, protractor, fulcrum, and movement arm to measure angle from axis of the joint. | baseline | 
| Manual Muscle Test | Manual muscle testing is a procedure for the evaluation of the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance. | baseline | 
| Pain Scale | A pain scale measures a patient's pain intensity or other features. Pain scales are based on self-report, observational (behavioral), or physiological data. | baseline | 
| Disabilities of the Arm, Shoulder and Hand questionnaire（DASH） | The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neck dissection surgery, shoulder disability, musculoskeletal ultrasonography