Pedal Pump and Leg Lymphedema

ConditionLymphedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-100
SponsorRowan University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Age 55 years old or older

Have lower leg lymphedema

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Osteopathic Pedal Pump

    Other intervention

    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

    Other intervention

    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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Osteopathic Pedal PumpExperimental treatment 1 intervention
Group B: Light Touch TreatmentSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in limb volume

Difference in lower limb volume, as measured by water displacement, from pre to post-treatment.

Time frame
The time frame in which the pre and post-treatment measurements will take place in one session that will take approximately 30-45 minutes.

Secondary outcomes

Other outcomes

Sponsors and contacts

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