Back to resultsCan the Osteopathic Pedal Pump Reduce Lymphedema in the Lower Extremities in the Elderly? A Mentorship Project.
Primary Purpose
Lymphedema, Lower Limb
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic manipulative medicine pedal pump
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema, Lower Limb
Eligibility Criteria
Inclusion Criteria:
- For phase one subjects must be age 18 or older, be a medical students at Rowan University School of Osteopathic Medicine and not have leg edema which does not resolve with overnight limb elevation. For phase two subjects must be patients at the NJISA in Stratford, NJ age 55 and over and have lower limb lymphedema. Lymphedema is defined as edema that does not resolve with overnight elevation of the lower limb.
Exclusion Criteria:
- Exclusion criteria is the same for both phases. Because the measurements involve placing the lower limb into water subjects with an open wound, sore or cellulitis in the lower limbs will be excluded to ensure good hygiene. Because lymphatic pumping can cause a redistribution of volume in the body, subjects with decompensated heart failure, acute asthma, COPD exacerbation, or active cancer will be excluded. For obvious reasons, those with a non-healed or healing bone fractures will be excluded. Due to potential problems with informed consent those with a diagnosis of dementia on the chart problem list will be excluded.
Sites / Locations
- Rowan University School of Osteopathic Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Osteopathic manipulative medicine pedal pump
Arm Description
Outcomes
Primary Outcome Measures
Change in lower limb volume
Patient's lower limb volume measured via volumetric edema gauge
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05119517
Brief Title
Can the Osteopathic Pedal Pump Reduce Lymphedema in the Lower Extremities in the Elderly? A Mentorship Project.
Official Title
Can the Osteopathic Pedal Pump Reduce Lymphedema in the Lower Extremities in the Elderly? A Mentorship Project.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
November 12, 2021 (Actual)
Study Completion Date
November 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rowan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic lymphedema is defined as swelling or edema (excess fluid in the interstitial space) that does not fully resolve overnight by elevating the limb or body part to the level of the heart. Chronic lymphedema is a major clinical problem that is difficult to treat. Osteopathic Pedal Pump is a simple manipulation technique anecdotally thought to reduce leg edema and chronic lymphedema. However, the clinical evidence is only anecdotal and no clinical trials have ever been conducted to test this observation. The purpose of the research is to measure the effectiveness of the Osteopathic Pedal Pump technique for treating lymphedema by measuring before and after treatment limb volumes. The second purpose of this project is to mentor osteopathic medical students in clinical research. There is also a great need to mentor Osteopathic Medical Students because relatively few pursue careers involving clinical research and the benefits osteopathic manipulative treatment remain under investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Lower Limb
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Osteopathic manipulative medicine pedal pump
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Osteopathic manipulative medicine pedal pump
Intervention Description
In this 7 minute intervention, the patient receives 2 minutes of myofascial release of the thoracic inlet and then 5 minutes of the pedal pump technique
Primary Outcome Measure Information:
Title
Change in lower limb volume
Description
Patient's lower limb volume measured via volumetric edema gauge
Time Frame
Baseline and 1-minute after receiving pedal pump protocol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For phase one subjects must be age 18 or older, be a medical students at Rowan University School of Osteopathic Medicine and not have leg edema which does not resolve with overnight limb elevation. For phase two subjects must be patients at the NJISA in Stratford, NJ age 55 and over and have lower limb lymphedema. Lymphedema is defined as edema that does not resolve with overnight elevation of the lower limb.
Exclusion Criteria:
Exclusion criteria is the same for both phases. Because the measurements involve placing the lower limb into water subjects with an open wound, sore or cellulitis in the lower limbs will be excluded to ensure good hygiene. Because lymphatic pumping can cause a redistribution of volume in the body, subjects with decompensated heart failure, acute asthma, COPD exacerbation, or active cancer will be excluded. For obvious reasons, those with a non-healed or healing bone fractures will be excluded. Due to potential problems with informed consent those with a diagnosis of dementia on the chart problem list will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Noll, DO
Organizational Affiliation
Rowan University School of Osteopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rowan University School of Osteopathic Medicine
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Can the Osteopathic Pedal Pump Reduce Lymphedema in the Lower Extremities in the Elderly? A Mentorship Project.
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