Clinical Evaluation of a Device for Treatment of Lymphedema of the Upper Extremity

For each study visit, participants will be asked to arrive 45 minutes before the beginning of their regularly scheduled follow-up visit. Research activities will take 45 minutes.

Upon early arrival to their regularly scheduled appointment, participants will be fitted for their very own, "athletic sleeve" by a member of the research team. This athletic sleeve will be used throughout the duration of the study. Participants will be asked to come wearing a tank top or short-sleeved t-shirt. If they do not come dressed as such, they will have the opportunity to change in a private space.

Before donning the athletic sleeve, a member of the research team will measure the participant's upper limb circumference and induration and administer a baseline survey using the first section of the Lymphedema Life Impact Scale (LLIS - document attached). Upper extremity circumference will be measured in centimeters at several points, which are: palmar crease, the wrist below the styloid process, wrist + 10 cm, wrist + 20 cm, wrist + 30 cm, and wrist + 40 cm. Upper extremity induration will be measured at the same points as circumference. These measurements are being taken solely for research purposes and should take approximately 3 minutes.

The athletic sleeve will be donned by the participant and the novel therapeutic device will be placed over it. A standardized sequence of vibratory therapy will be applied. Use of this device will not impact standard of care in any way. The participant may ask to stop the research session at any time

The athletic sleeve will then be removed, and a member of the research team will measure the participant's upper limb circumference and induration and administer a survey using the first section of the Lymphedema Life Impact Scale. These measurements are being taken solely for research purposes and should take approximately 3 minutes. Participants will be asked if they experienced any side effects or adverse effects.

Standardized decongestive therapy will be performed by qualified personnel. This step takes approximately 1 hour and would happen regardless or whether or not patients are enrolled in this study. At the conclusion of the standardized decongestive therapy, the measurements and surveys mentioned previously will be repeated. Participants will also be asked if they experienced any side effects with the standard of care treatment.

This series of steps will be repeated at the participants' weekly follow-up visits for four weeks. Standardized decongestive therapy for lymphedema is most often performed on a weekly basis (and is one of the inclusion criteria for this study). Therefore, choosing this visit frequency would not greatly alter a participant's schedule or ability to perform other daily tasks.

If a participant chooses to withdraw from the study early or needs to be removed from the study for their own safety, notes will be added to research documentation and the patient's electronic medical chart indicating their departure from the study. Going forward, they would receive standard decongestive therapy as before their participation in the study.

Study subject limb circumference, induration data, and survey data will be analyzed using a paired t-test.

Inclusion criteria

• 18 years of age or older
• Clinical diagnosis of lymphedema
• Receiving current, once weekly, lymphedema treatment by Physical Therapist(PT)/Occupational Therapist (OT)
• Participants must have the ability to provide consent for themselves

Exclusion criteria

• Active infection
• Active cancer (not in remission)
• Diagnosis of/past medical history of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
• Active phlebitis
• Diagnosis of Congestive Heart Failure (CHF)
• Previous severe trauma (i.e. requiring extensive corrective surgery)
• History of vascular surgery
• Lesions of the skin or weeping in the treatment area