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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02369276
Enrollment
38
Registered
2015-02-23
Start date
2015-04-30
Completion date
2017-12-31
Last updated
2018-05-14

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

Conditions

Head and Neck Cancer

Keywords

neck dissection surgery, shoulder disability, musculoskeletal ultrasonography

Brief summary

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

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).

Interventions

OTHERultrasonography and elastography

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

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
2-Item findings of musculoskeletal ultrasonography and elastographybaseline

Secondary

MeasureTime frameDescription
Range of motionbaselineEach 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.
Manual Muscle TestbaselineManual 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.
Pain ScalebaselineA pain scale measures a patient's pain intensity or other features. Pain scales are based on self-report, observational (behavioral), or physiological data.
Disabilities of the Arm, Shoulder and Hand questionnaire(DASH)baselineThe 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026