Can the Osteopathic Pedal Pump Reduce Lymphedema in the Lower Extremities in the Elderly? A Mentorship Project.

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.

Study Overview

• Status: Completed
• Conditions: Lymphedema, Lower Limb
• Intervention / Treatment: Other: Osteopathic manipulative medicine pedal pump

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Stratford, New Jersey, United States, 08084
      • Rowan University School of Osteopathic Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osteopathic manipulative medicine pedal pump	Other: Osteopathic manipulative medicine pedal pump; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lower limb volume	Patient's lower limb volume measured via volumetric edema gauge	Baseline and 1-minute after receiving pedal pump protocol

Collaborators and Investigators

• Sponsor: Rowan University
• Investigators: Principal Investigator: Donald Noll, DO, Rowan University School of Osteopathic Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Actual): November 12, 2021
• Study Completion (Actual): November 12, 2021

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: PRO-2020-72

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No