Pedal Pump and Leg Lymphedema

Rowan University

Status: Enrolling

Conditions: Lymphedema

Treatments: Other: Light Touch Treatment; Other: Osteopathic Pedal Pump

Study type: Interventional

Funder types: Other

Identifiers

NCT06235463

PRO-2023-254

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 55 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Osteopathic Pedal Pump

Experimental group

Description:

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.

Treatment:

Other: Osteopathic Pedal Pump

Light Touch Treatment

Sham Comparator group

Description:

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.

Treatment:

Other: Light Touch Treatment