Can the Osteopathic Pedal Pump Reduce Lymphedema in the Lower Extremities in the Elderly? A Mentorship Project.

NCT05119517 | Completed

• 1 other identifier: PRO-2020-72
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic lymphedema is defined as swelling or edema (excess fluid in the interstitial space) that does not fully resolve overnight by elevating the limb or body part to the level of the heart. Chronic lymphedema is a major clinical problem that is difficult to treat. Osteopathic Pedal Pump is a simple manipulation technique anecdotally thought to reduce leg edema and chronic lymphedema. However, the clinical evidence is only anecdotal and no clinical trials have ever been conducted to test this observation. The purpose of the research is to measure the effectiveness of the Osteopathic Pedal Pump technique for treating lymphedema by measuring before and after treatment limb volumes. The second purpose of this project is to mentor osteopathic medical students in clinical research. There is also a great need to mentor Osteopathic Medical Students because relatively few pursue careers involving clinical research and the benefits osteopathic manipulative treatment remain under investigated.

Conditions

Lymphedema, Lower Limb

Outcome Measures

Primary Outcomes (1)

• Change in lower limb volume

  Patient's lower limb volume measured via volumetric edema gauge

  Baseline and 1-minute after receiving pedal pump protocol

Study Arms (1)

Osteopathic manipulative medicine pedal pump

EXPERIMENTAL

Other: Osteopathic manipulative medicine pedal pump

Interventions

Osteopathic manipulative medicine pedal pump OTHER

In this 7 minute intervention, the patient receives 2 minutes of myofascial release of the thoracic inlet and then 5 minutes of the pedal pump technique

Osteopathic manipulative medicine pedal pump

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For phase one subjects must be age 18 or older, be a medical students at Rowan University School of Osteopathic Medicine and not have leg edema which does not resolve with overnight limb elevation. For phase two subjects must be patients at the NJISA in Stratford, NJ age 55 and over and have lower limb lymphedema. Lymphedema is defined as edema that does not resolve with overnight elevation of the lower limb.

Sponsors & Collaborators

• Rowan University: lead

Study Sites (1)

Rowan University School of Osteopathic Medicine

Stratford, New Jersey, 08084, United States

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Donald Noll, DO

  Rowan University School of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 15, 2021
• Study Start: March 24, 2021
• Primary Completion: November 12, 2021
• Study Completion: November 12, 2021
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

US (1)