Pedal Pump and Leg Lymphedema

Effectiveness of the Osteopathic Pedal Pump in Reducing Lower Limb Volume in Older Adults with Chronic Leg Lymphedema

Chronic lymphedema in the lower extremities is a common problem found in older adults that can result in cellulitis, poor wound healing, venous stasis ulcers, and other comorbidities. Compressive therapies are the present gold standard for the manual treatment of lymphedema in the lower extremities. However, the benefits of these compressive therapies are modest, and they are not well tolerated by older adults. An alternative manual treatment is the osteopathic pedal pump, an osteopathic manipulative treatment, that uses a rhythmical pumping motion instead of compressive force to move interstitial fluid from the lower extremities back to the circulatory system. However, the evidence that the osteopathic pedal pump can reduce volume in the lower extremities remains anecdotal. The aim of this study is to determine if the osteopathic pedal pump can reduce volume in the lower extremities among older adults with chronic lymphedema. Leg volume will be measured using water displacement. Older adults with chronic lymphedema of the lower extremities will be randomly assigned to one of two groups: a treatment group that will receive one session of the osteopathic pedal pump and a control group that will receive one session of a light touch treatment.

Study Overview

• Status: Recruiting
• Conditions: Lymphedema
• Intervention / Treatment: Other: Osteopathic Pedal Pump; Other: Light Touch Treatment

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matt McLaughlin; Phone Number: (856) 566-6330; Email: mclaugmh@rowan.edu

Study Locations

• United States
  • New Jersey
    • Stratford, New Jersey, United States, 08084
      • Recruiting
      • Rowan University School of Osteopathic Medicine
      • Contact: Matt McLaughlin; Phone Number: (856) 566-6330; Email: mclaugmh@rowan.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 55 years old or older
• Have lower leg lymphedema

Exclusion Criteria:

• Any type of acute medical issue or exacerbation
• A chronic medical condition (e.g., asthma, chronic obstructive pulmonary disease, congestive heart failure)
• An active tissue infection or an open wound in the lower limb
• An active bone fracture
• Acute deep venous thrombosis not fully anticoagulated
• Dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osteopathic Pedal Pump; Participant lays supine on the table and the operator stands at foot of table. Operator places hands on the feet, contacting the balls of the feet, and carefully plantar flexing to a slight degree. Operator dorsiflexes the feet to cause the whole body to move cephalad. The body is allowed to rebound back caudad towards foot of the table. The operator times the next dosiflexion motion to occur towards the end of the caudad motion wave. Technique time is 5 minutes.	Other: Osteopathic Pedal Pump; Participants randomized to this condition will receive 5 minutes of myofascial release to the thoracic inlet and 5 minutes of the pedal pump technique.
Sham Comparator: Light Touch Treatment; Participant lays supine on the table and the operator stands at foot of table. Operator places hands on the feet and touches participant body on the balls of the feet, but operator does not palpate feet or lower limbs.	Other: Light Touch Treatment; Participants randomized to receive the sham treatment will receive light touch from the operator on the base of the neck and the balls of the feet. This light touch is meant to mimic the pedal pump through touching the same areas of the body but without palpating so that no lymphatic fluid is removed from the lower limbs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in limb volume	Difference in lower limb volume, as measured by water displacement, from pre to post-treatment.	The time frame in which the pre and post-treatment measurements will take place in one session that will take approximately 30-45 minutes.

Collaborators and Investigators

• Sponsor: Rowan University

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Estimated): August 8, 2025
• Study Completion (Estimated): November 8, 2025

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: PRO-2023-254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No