Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
72 participants
INTERVENTIONAL
2024-04-09
2025-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Osteopathic Pedal Pump
Participant lays supine on the table and the operator stands at foot of table. Operator places hands on the feet, contacting the balls of the feet, and carefully plantar flexing to a slight degree. Operator dorsiflexes the feet to cause the whole body to move cephalad. The body is allowed to rebound back caudad towards foot of the table. The operator times the next dosiflexion motion to occur towards the end of the caudad motion wave. Technique time is 5 minutes.
Osteopathic Pedal Pump
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
Participant lays supine on the table and the operator stands at foot of table. Operator places hands on the feet and touches participant body on the balls of the feet, but operator does not palpate feet or lower limbs.
Light Touch Treatment
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.
Interventions
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Osteopathic Pedal Pump
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
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.
Eligibility Criteria
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Inclusion Criteria
* Have lower leg lymphedema
Exclusion Criteria
* 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
55 Years
100 Years
ALL
Yes
Sponsors
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Rowan University
OTHER
Responsible Party
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Locations
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Rowan University School of Osteopathic Medicine
Stratford, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PRO-2023-254
Identifier Type: -
Identifier Source: org_study_id
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