Pedal Pump and Leg Lymphedema

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06235463
• Other study ID #: PRO-2023-254
• Status: Recruiting
• Phase: N/A
• Start date: April 9, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: Rowan University
• Contact: Matt McLaughlin
• Phone: (856) 566-6330
• Email: mclaugmh[@]rowan.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: February 28, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rowan University School of Osteopathic Medicine	Stratford	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rowan University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.