Chang Gung Memorial Hospital
Kaohsiung City, Niaonsung Hsiang, 83301, Taiwan
NCT Number: NCT02369276
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.
Looking for future studies?
Notify Me20 year–65 year
All sexes
Observational
Kaohsiung City, Niaonsung Hsiang, 83301, Taiwan
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
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
Time frame: baseline
Time frame: baseline
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.
Time frame: baseline
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.
Time frame: baseline
A pain scale measures a patient's pain intensity or other features. Pain scales are based on self-report, observational (behavioral), or physiological data.
Time frame: baseline
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.
Chang Gung Memorial Hospital
Other
Musculoskeletal Ultrasonographic Assessment for the Soft Tissue Injury of Ipsilateral Shoulder of Head and Neck Cancer Patient Following Selective Neck Dissection
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05570851
Alcohol Drinking, Alcohol Use, Unspecified
Manhasset, New York, United States
View Trial DetailsNCT04208490
Head and Neck Cancer, Head and Neck Neoplasms
Kingman, Arizona, United States
View Trial DetailsNCT03117946
Head and Neck Cancer, Head and Neck Neoplasms
Besançon, France
View Trial DetailsNCT00076310
Carcinoma, Carcinoma, Squamous Cell
Houston, Texas, United States
View Trial Details