Pedal Pump and Leg Lymphedema

Last updated: November 14, 2024
Sponsor: Rowan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphedema

Treatment

Light Touch Treatment

Osteopathic Pedal Pump

Clinical Study ID

NCT06235463
PRO-2023-254
  • Ages 55-100
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 55 years old or older

  • Have lower leg lymphedema

Exclusion

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 Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Light Touch Treatment
Phase:
Study Start date:
April 09, 2024
Estimated Completion Date:
November 08, 2025

Connect with a study center

  • Rowan University School of Osteopathic Medicine

    Stratford, New Jersey 08084
    United States

    Active - Recruiting

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