Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema
This study will compare 5 non-invasive lymphedema treatments.
Patients will be assigned to either:
- A combination of arm exercises, arm elevation, and wearing of a compression garment every
day
OR
- One of four possible pneumatic compression devices for just two hours every day.
Pneumatic compression devices are made up of an inflatable sleeve connected to a small
controller unit that is plugged into the wall. They feel like having your blood pressure
taken.
None of the treatments are experimental. None of the treatments are invasive. All the
treatments are considered standard of care and are used in clinics throughout the United
States. All of the treatments will be done at home.
The trial will last for 7 and 1/2 months and will require follow-up visits to monitor
progress.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Arm Volume
Arm volume will be measured at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
No
Arin K Greene, MD, MMSc
Principal Investigator
Children's Hospital Boston
United States: Institutional Review Board
AQ-UE-LYMPHEDMA-PCD-RCT
NCT00951067
August 2009
August 2011
Name | Location |
---|---|
Children's Hospital Boston at Waltham | Waltham, Massachusetts 02453 |