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NCT Number: NCT06235463

Pedal Pump and Leg Lymphedema

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.

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Key information

Age range

55 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rowan University School of Osteopathic Medicine

Stratford, New Jersey, 08084, United States

Location status: Recruiting

Location contact

Matt McLaughlin

CONTACT

[email protected]

(856) 566-6330

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic Pedal Pump

Other

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

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.

Primary outcomes

  1. Change in limb volume

    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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Matt McLaughlin

CONTACT

[email protected]

(856) 566-6330

Sponsors and collaborators

Lead sponsor

Rowan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 1, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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