The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events.
Study Type
OBSERVATIONAL
Enrollment
18
Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed
Iowa ENT Center
West Des Moines, Iowa, United States
Charles George VA Medical Center
Asheville, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Symptom/Problem Improvement From Baseline to 6 Months
To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Positive value shows an increase in symptoms/problems. Negative value shows a decrease in symptoms/problems. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.
Time frame: Percent Changes between Baseline and 6 months will be assessed
Function (Range of Motion) Improvement From Baseline to 6 Months
To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Positive value shows an increase in Function/Range of Motion. Negative value shows a decrease in Function/Range of Motion. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline.
Time frame: Percent Changes between Baseline and 6 months will be assessed
Changes in Health-related Quality of Life From Baseline to 6 Months
Subject Quality of Life will be assessed using EORTC C30 questionnaire. Positive value shows an decrease in quality of life. Negative value shows a increase in quality of life. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.
Time frame: Percent Changes between Baseline and 6 months will be assessed
Changes in Health-related Quality of Life-Overall From Baseline to 6 Months
Subject overall health and quality of life in the past week-EORTC C30. Positive value shows an increase in quality of life/overall health. Negative value shows a decrease in quality of life/overall health. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.
Time frame: Percent Changes between Baseline and 6 months will be assessed
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Changes in Pain From Baseline to 6 Months
Pain will be assessed using the VAS Pain Scale. Positive value shows an increase in pain. Negative value shows a decrease in pain. Percent change is calculated by the difference between scores averaged at 6 months versus baseline.
Time frame: Percent Changes between Baseline and 6 months will be assessed
Change in Swelling From Baseline to 6 Months
Swelling will be assessed using the ALOHA measurement protocol. Positive value shows an increase in swelling. Negative value shows a decrease in swelling. Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline.
Time frame: Percent Changes between Baseline and 6 months will be assessed
Ease of Use/Satisfaction
Both Ease of Use/Satisfaction will be assessed by survey. Percentage of each response captured.
Time frame: Assessed at 6 months