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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Osteopathic Pedal Pump treatment for lymphedema?

Research on similar treatments, like the Wright Linear Pump, shows significant improvement in reducing limb swelling in lymphedema patients. Additionally, manual lymph drainage techniques, which are part of the Osteopathic Pedal Pump approach, have been shown to help manage lymphedema effectively. ^{1 2 3 4 5}

Is the Osteopathic Pedal Pump safe for humans?

Research on similar treatments like the Lymphapress pump and Wright linear pump for lymphedema shows they are generally safe, with most participants experiencing no complications. However, specific safety data for the Osteopathic Pedal Pump itself is limited. ^{3 4 5 6 7}

How does the Osteopathic Pedal Pump treatment for lymphedema differ from other treatments?

The Osteopathic Pedal Pump treatment is unique because it uses a hands-on technique to manually stimulate lymphatic flow, which is different from other treatments that might rely on medication or mechanical devices. This approach is non-invasive and focuses on enhancing the body's natural ability to reduce fluid buildup. ^{8 9 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of adult lower extremity lymphedema with the Wright linear pump: statistical analysis of a clinical trial. [2006]

2. Australia pubmed.ncbi.nlm.nih.gov

Godoy & Godoy technique in the treatment of lymphedema for under-privileged populations. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A retrospective study of the effects of the Lymphapress pump on lymphedema in a pediatric population. [2006]

4. Canada pubmed.ncbi.nlm.nih.gov

Postmastectomy lymphedema treated with the Wright linear pump. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

What's New in Lymphedema Therapy in America? [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model. [2023]

8. France pubmed.ncbi.nlm.nih.gov

[Mechanical methods of treating refractory cardiac failure]. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Less invasive implantation of HeartWare left ventricular assist device. [2016]

10. England pubmed.ncbi.nlm.nih.gov

An introduction to mechanical circulatory support in cardiac intensive care. [2021]

11. Poland pubmed.ncbi.nlm.nih.gov

The role of long-term mechanical circulatory support in the treatment of end-stage heart failure. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Management of left ventricular distension during peripheral extracorporeal membrane oxygenation for cardiogenic shock. [2022]