Pedal Pump and Leg Lymphedema

Part of paid clinical trials in Stratford, New Jersey.

Sponsor
Rowan University
Study ID
NCT06235463
Status
Recruiting
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Conditions

  • Lymphedema

Eligibility Criteria

Sex
ALL
Age
55 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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 Dates

Start date
Apr 9, 2024
Status verified
Nov 2024
Primary completion
Aug 8, 2025
Completion
Nov 8, 2025

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Sham Comparator: 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.

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rowan University School of Osteopathic MedicineStratfordNew Jersey08084
Matt McLaughlin
[email protected]
(856) 566-6330

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Rowan University School of Osteopathic Medicine· Stratford, NJ

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