Pedal Pump and Leg Lymphedema
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Lymphedema
In brief
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.
Key facts
- Study ID
- NCT06235463
- Run by
- Rowan University
- People needed
- 72
- Starts
- 2024-04-09
- Expected to finish
- 2025-11-08
- Last updated by the study team
- 2024-11-18
Who can join
Age: 55 and older, up to 100. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 55 years old or older
- Have lower leg lymphedema
You may not qualify if…
- 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
Where it is running
- Rowan University School of Osteopathic Medicine — Stratford, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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