Osteopathic Pedal Pump for Lymphedema

Overseen By Matt McLaughlin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rowan University

Disqualifiers: Asthma, COPD, CHF, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 30-45 minutes

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist older adults with chronic lymphedema in their legs. Traditional treatments often involve tight bandages, which can be uncomfortable. This study tests a gentle technique called the osteopathic pedal pump, a type of osteopathic manipulative treatment. Participants will receive either this treatment or a light touch session to determine its effectiveness in reducing leg swelling. The trial seeks participants aged 55 or older with ongoing lower leg swelling. As an unphased trial, it offers participants the chance to explore innovative treatment options that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the osteopathic pedal pump is safe for treating lymphedema?

Research has shown that the osteopathic pedal pump is generally safe. In studies where the pedal pump was used on individuals without leg swelling (lymphedema), it reduced limb size and was well-tolerated. Similar treatments, such as the Lymphapress and Wright linear pumps, have proven safe in most cases, with few negative side effects reported. Although specific data on the pedal pump for lymphedema is limited, past experiences with similar methods suggest it is likely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Osteopathic Pedal Pump technique for lymphedema because it offers a non-invasive and drug-free approach that could complement or even enhance existing treatments. Unlike traditional therapies that often focus on compression garments or manual lymphatic drainage, the Osteopathic Pedal Pump uses a rhythmic foot motion to naturally stimulate lymphatic flow throughout the body. This technique is notable for its simplicity and quick application, taking only five minutes, and it may provide a gentle yet effective way to manage lymphedema symptoms without the need for complex equipment or medication.

What evidence suggests that the osteopathic pedal pump is effective for chronic lymphedema?

Research has shown that the osteopathic pedal pump, one of the treatments studied in this trial, can help reduce leg swelling. This technique moves fluid from the legs back into the body's circulation. Tests with individuals without leg lymphedema showed a noticeable decrease in leg size, suggesting the pedal pump might also benefit those with lymphedema. However, most current evidence relies on personal reports, so further studies are needed to confirm its effectiveness for long-term lymphedema in older adults. Participants in this trial may receive either the osteopathic pedal pump or a light touch treatment as a sham comparator. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for older adults aged 55 or above who are experiencing chronic lymphedema in their lower legs. It's not suitable for individuals who may have conditions that disqualify them from the study, but these specific conditions aren't listed here.

Inclusion Criteria

I am 55 years old or older.

I have swelling in my lower leg due to lymph fluid buildup.

Exclusion Criteria

Dementia

I have a long-term health condition like asthma or heart failure.

I have a recent deep vein clot and am not fully on blood thinners.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive one session of either the osteopathic pedal pump or a light touch treatment

30-45 minutes

1 visit (in-person)

Follow-up

Participants are monitored for changes in limb volume post-treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Light Touch Treatment
• Osteopathic Pedal Pump

Trial Overview

The study is testing whether an osteopathic pedal pump technique can reduce leg swelling compared to a light touch treatment. Participants will be randomly placed into two groups; one will receive the pedal pump method and the other a light touch control treatment.

How Is the Trial Designed?

Group I: Osteopathic Pedal Pump Experimental Treatment 1 Intervention

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.

Group II: Light Touch Treatment Placebo Group 1 Intervention

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 is already approved in United States, European Union for the following indications:

Approved in United States as Osteopathic Pedal Pump for:

• Chronic lymphedema in the lower extremities

Approved in European Union as Osteopathic Manipulative Treatment for:

• Lymphedema management
• Manual therapy for fluid mobilization

Who Is Running the Clinical Trial?

Rowan University

Lead Sponsor

Trials

25

Recruited

3,000+

Published Research Related to This Trial

Mechanical circulatory support is a viable alternative treatment for patients with end-stage heart failure, offering significantly better long-term survival compared to standard medical therapy.

Identifying eligible patients for mechanical circulatory support is crucial, as it can improve both their lifespan and quality of life, especially given the limited availability of heart transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of long-term mechanical circulatory support in the treatment of end-stage heart failure. Paluszkiewicz, L., Kukulski, T., Zembala, M., et al.[2019]

In a study of 16 children with lymphedema, 93% showed a clinical trend towards reduced or maintained limb size after using the Lymphapress pump, indicating its potential efficacy in managing lymphedema.

The treatment was generally safe, with 88% of subjects experiencing no complications directly related to the pump, suggesting it is a well-tolerated option for children with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective study of the effects of the Lymphapress pump on lymphedema in a pediatric population. Hassall, A., Graveline, C., Hilliard, P.[2006]

Mechanical circulatory support is increasingly used in various critical conditions, such as myocardial ischaemia and cardiogenic shock, providing effective treatment options for patients who may not respond to conventional therapies.

Different types of mechanical circulatory support, like intra-aortic balloon pumps and ventricular assist devices, serve specific functions, such as improving blood flow and oxygen delivery, which are crucial for patient recovery in acute settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An introduction to mechanical circulatory support in cardiac intensive care. Coppel, J., Rosenberg, A., Gilbert-Kawai, E.[2021]

In a study involving 884 patients, the incidence of adverse events immediately after osteopathic manipulative treatment (OMT) was found to be low at 2.5%, with pain or discomfort being the most common complaint.

Women reported experiencing adverse events more frequently than men, suggesting a potential demographic factor in the response to OMT, but overall, the rate of adverse events was lower than those reported in other manual therapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment. Degenhardt, BF., Johnson, JC., Brooks, WJ., et al.[2022]

In a phase II trial involving 15 patients with postmastectomy lymphedema, the Wright linear pump demonstrated subjective improvement and objective reduction in arm edema, indicating its efficacy in treating this condition.

The treatment was well tolerated with no reported complications, such as fluid overload, suggesting that the Wright linear pump is a safe and user-friendly option compared to other pneumatic compression devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postmastectomy lymphedema treated with the Wright linear pump. Kim-Sing, C., Basco, VE.[2007]

Left ventricular assist devices (LVADs) provide significant support for patients with left ventricular dysfunction, improving hemodynamic stability and aiding recovery from organ failure, especially when used as a bridge to transplantation.

The implementation of a less invasive surgical technique for LVAD implantation, which includes reduced surgical approaches and lower heparin doses, allows for faster patient recovery and extubation while maintaining low morbidity rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Less invasive implantation of HeartWare left ventricular assist device. Bottio, T., Bejko, J., Gallo, M., et al.[2016]

Peripheral veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can be controversial in treating cardiogenic shock due to risks of left ventricular distension and pulmonary edema, which can occur if the left heart is not adequately drained.

The article discusses both the underlying causes of these complications and clinical strategies to prevent them, highlighting the importance of managing left ventricular function during VA-ECMO treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of left ventricular distension during peripheral extracorporeal membrane oxygenation for cardiogenic shock. Soleimani, B., Pae, WE.[2022]

In a clinical trial involving 73 adult lymphedema patients, the Wright Linear Pump significantly reduced leg circumference after 48 hours of treatment, demonstrating its efficacy for managing lower extremity lymphedema.

The treatment was effective for both men and women, with no significant influence from factors like age or previous treatment methods, indicating broad applicability of the Wright Linear Pump for lymphedema patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of adult lower extremity lymphedema with the Wright linear pump: statistical analysis of a clinical trial. Klein, MJ., Alexander, MA., Wright, JM., et al.[2006]

New treatment options for lymphedema have been developed, including advanced manual lymph drainage techniques and innovative compression mechanisms, which can be particularly beneficial for under-privileged populations.

The introduction of active and passive exercise devices, along with adapted myolymphokinetic activities, offers a comprehensive approach to treating lymphedema on a larger scale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Godoy & Godoy technique in the treatment of lymphedema for under-privileged populations. de Godoy, JM., de Godoy, Mde F.[2022]

Mechanical support devices for congestive heart failure, such as intra-aortic balloon pumps and bypass pumps, are increasingly used when standard treatments fail, but their efficacy is limited and context-dependent, particularly in cases of cardiogenic shock or right-sided heart failure.

These devices can help the heart recover by reducing workload, but their use is complicated by potential impacts on blood coagulation and pulmonary function, highlighting the need for careful patient selection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mechanical methods of treating refractory cardiac failure]. Dreyfus, G.[2019]

A systematic review of 23 studies found that the majority of adverse events (AEs) following osteopathic manipulative treatment (OMT) were mild, accounting for 98% of reported AEs, indicating a generally safe profile for this treatment.

The study established a patient safety benchmark for post-OMT AEs at 1.0 AEs per 100 post-OMT interval-days, providing a reference point for future research and comparisons in patient safety within osteopathic manipulative medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model. Unger, MD., Barr, JN., Brower, JA., et al.[2023]

Complete decongestive physiotherapy (CDP) is a safe, effective, and noninvasive treatment for lymphedema, which has been largely overlooked in American medical practice; the author treated 2000 patients (1000 with upper and 1000 with lower extremity lymphedema) between 1989 and 1995, averaging 25 treatments per patient.

CDP therapy resulted in significant volumetric reductions in lymphedema, and follow-up examinations one year post-treatment showed lasting improvements, suggesting that CDP is superior to surgical options and pneumatic pump therapies for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What's New in Lymphedema Therapy in America? Lerner, R.[2020]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05119517

Can the Osteopathic Pedal Pump Reduce Lymphedema in ...

The purpose of the research is to measure the effectiveness of the Osteopathic Pedal Pump technique for treating lymphedema by measuring before and after ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36701752/

Does the osteopathic pedal pump reduce lower limb ...

The osteopathic pedal pump technique, when utilized on those without leg lymphedema, reduces lower limb volume as measured by the volumetric water gauge.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06235463

NCT06235463 | Pedal Pump and Leg Lymphedema

An alternative manual treatment is the osteopathic pedal pump, an osteopathic manipulative treatment, that uses a rhythmical pumping motion instead of ...

4.

rdw.rowan.edu

rdw.rowan.edu/cgi/viewcontent.cgi?article=1178&context=som_facpub

Does the Osteopathic Pedal Pump Reduce Lower Limb ...

Conclusions: The osteopathic pedal pump technique, when utilized on those without leg lymphedema, reduces lower limb volume as measured by the ...

5.

withpower.com

withpower.com/trial/phase-lymphedema-1-2024-3fe62

Osteopathic Pedal Pump for Lymphedema

Research on similar treatments, like the Wright Linear Pump, shows significant improvement in reducing limb swelling in lymphedema patients. Additionally, ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35032224/

The Effect of Pedal Pump Lymphatic Technique Versus ...

This study compared the use of pedal pump lymphatic technique to passive supine recovery following maximal exercise.