Previous research on the osteopathic manual technique entitled "Pedal Pump" has shown health benefits, specifically increasing lymphatic flow, decreasing lower extremity edema, and decreasing serum lactic acid after maximal exercise. However, due to the limitation of human practitioners, research has been limited.
The Pedal Pump is now a device which facilitates consistency in treatment and allows for increased sample size in research. This clinical trial studies the effects of 10 minutes of Pedal Pump treatment for hospitalized patients with lower extremity edema.
Key Question for this first study: Is the Pedal Pump a feasible treatment for hospitalized patients? Secondary question: Does the Pedal Pump decrease lower extremity edema?
This is a novel idea in its early stage of development, so Investigators anticipate product advancements, further testing with larger population sizes, and future publications.
Bilateral lower extremity edema of at least mild severity judged by the treating clinician to be due to CHF, chronic venous insufficiency, kidney disease, or other etiologies of fluid overload conditions.
Medically stable
Able to remain in Fowler position for 10 minutes
Patients in the ER, observation, or admitted to the hospital for any period of time; outpatients (specifically CHF clinic patients)
Patients using a hospital bed which has the scale on the foot board
Lymphedema (interstitial protein-built fluid)
Lipedema (fat distribution)
Pressure ulcers
Parallel
Pedal Pump
DeviceThe Pedal Pump device pumps both feet for 10 minutes continuously-- mobilizing their whole body in sufficient manner to see the nose move.
Pedal Pump Sham
DeviceThe Sham Intervention is the same as Pedal Pump Intervention with the exact same Pedal Pump device generating identical operational sounds and visible movement; however, the patient's body will not be close enough to the device to produce sufficient displacement to transmit mechanical forces beyond the feet. The Pedal Pump will only contact the heel protector pillows enough to make the toes move but will not contact them enough to mobilize the legs or the entire body.
No Treatment-Related Adverse Events Scoring 3, 4, or 5 on the CTCAE v4.0 scale
Treatment-related adverse events will be assessed by CTCAE v4.0 on a 1-5 scale: * Grade 1 (Mild): Asymptomatic or mild symptoms. * Grade 2 (Moderate): Minimal, local, or noninvasive intervention indicated. * Grade 3 (Severe): Severe but not immediately life-threatening; hospitalization indicated. * Grade 4 (Life-threatening): Urgent intervention indicated. * Grade 5 (Death): Death related to the AE. Adverse Events monitors will be such as, but not limited to: * New pain * Worsened pain * Dizziness * Blood pressure instability * Skin irritation * Muscle cramping * Abdominal cramping * Anxiety * Nausea * Syncope * Chest pain of cardiac origin * Sustained arrhythmia * Stroke symptoms * Hypoxia * Hypotension Treatment will stop immediately if a Grade 3, 4, or 5 adverse event occurs. The Investigators will keep record of the number of patients having adverse events and their severities.
Treatment Tolerability
≥95% treatment tolerability (\<5% "aborted" treatments)
Change in Lower Extremity Edema
≥1 cm change in average lower extremity circumferences
No increase in pain or stress in ≥80% of the treatment group
No increase in pain or stress in ≥80% of the treatment group per patient-reported symptoms using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe)
<20% of Treatment Group having Treatment-Related Adverse Events scoring 2 per CTCAE v4.0
Treatment-related adverse events will be assessed by CTCAE v4.0 on a 1-5 scale: * Grade 1 (Mild): Asymptomatic or mild symptoms. * Grade 2 (Moderate): Minimal, local, or noninvasive intervention indicated. * Grade 3 (Severe): Severe but not immediately life-threatening; hospitalization indicated. * Grade 4 (Life-threatening): Urgent intervention indicated. * Grade 5 (Death): Death related to the AE. Adverse Events monitors will be such as, but not limited to: * New pain * Worsened pain * Dizziness * Blood pressure instability * Skin irritation * Muscle cramping * Abdominal cramping * Anxiety * Nausea * Syncope * Chest pain of cardiac origin * Sustained arrhythmia * Stroke symptoms * Hypoxia * Hypotension
Click on the lead sponsor to view all of their trials.
David McVay
Lead sponsor
Hillcrest
Sponsor institution
