Pedal Pump and Leg Lymphedema

Not Applicable

Recruiting

• Conditions: Lymphedema
• Interventions: Other: Light Touch Treatment; Other: Osteopathic Pedal Pump

• Registration Number: NCT06235463
• Lead Sponsor: Rowan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-02-01
• Study Start: 2024-04-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2025-08-08
• Study Completion: 2025-11-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Light Touch Treatment	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.
Osteopathic Pedal Pump	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.

Primary Outcome Measures

Name	Time	Method
Change in limb volume	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.

Trial Locations

Locations (1)

Rowan University School of Osteopathic Medicine; 🇺🇸 Stratford, New Jersey, United States