Actively Recruiting

Phase Not Applicable
Age: 55Years - 100Years
All Genders
Healthy Volunteers
NCT06235463

Pedal Pump and Leg Lymphedema

Led by Rowan University · Updated on 2024-11-18

72

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pedal Pump and Leg Lymphedema

Who Can Participate

Age: 55Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 55 years old or older
  • Have lower leg lymphedema
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rowan University School of Osteopathic Medicine

Stratford, New Jersey, United States, 08084

Actively Recruiting

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Research Team

M

Matt McLaughlin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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