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

NCT02369276 | Completed DMC

• 1 other identifier: CMRPG8D1201
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

neck dissection surgery; shoulder disability; musculoskeletal ultrasonography

Outcome Measures

Primary Outcomes (1)

• 2-Item findings of musculoskeletal ultrasonography and elastography

  baseline

Secondary Outcomes (4)

• Range of motion

  baseline

• Manual Muscle Test

  baseline

• Pain Scale

  baseline

• Disabilities of the Arm, Shoulder and Hand questionnaire（DASH）

  baseline

Study Arms (5)

post SND within 3 months

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

post SND within >3- 6months

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

post SND within 6 months -1 year

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

post SND within more than 1 year

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

without shoulder disability

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

Interventions

ultrasonography and elastography OTHER

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

post SND within 3 months; post SND within 6 months -1 year; post SND within >3- 6months; post SND within more than 1 year; without shoulder disability

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• head and neck cancer by Never-Sparing Selective Neck dissection, SND, the skin condition is stable, there is no wound, infection or inflammation metastasis.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, Niaonsung Hsiang, 83301, Taiwan

Location

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MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Chau-Peng Leong, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: February 23, 2015
• Study Start: April 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: May 14, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)