NCT06495021

Brief Summary

This study is to see Osteopathic Manipulative Therapy, or OMT, can aid in treating patients being seen for respiratory illness and associated symptoms. The hypothesis is that the addition of OMT therapy, alongside other standard care (such as a medication), can help lessen patient symptoms sooner than just other treatment alone, and the duration of the condition will shorten as well.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Dec 2024Jun 2026

First Submitted

Initial submission to the registry

July 3, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

December 31, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

July 3, 2024

Last Update Submit

July 7, 2025

Conditions

Keywords

Osteopathic Manual TherapyRespiratory IllnessOMT

Outcome Measures

Primary Outcomes (1)

  • To address the magnitude in which lymphatic pump OMT improves respiratory illness symptom severity and overall sickness duration when combined with standard care treatment.

    Survey given to patients will provide feedback to capture their symptom severity at the time of diagnosis and 5 days post-diagnosis

    Through study completion of up to one year.

Study Arms (2)

Control

NO INTERVENTION

Patients in the control group will receive normal standard care, including any prescriptions, follow-up instructions, etc., as given by the provider to help treat their condition.

Treatment

EXPERIMENTAL

Patients will receive lymphatic pump OMT therapy in addition to other standard care (similar to the control patients, this would be a medication, follow-up instructions, etc.)

Procedure: Lymphatic Pump Osteopathic Manipulative Therapy

Interventions

OMT is a series of manual pressure and physical stimulation among various parts of the body to stimulate fluid movement and immune response in patients with various symptoms and disease. This may help with conditions such as edema, clearance of infections, facilitate healing and circulation, and bolster the immune response. Specifically, the lymphatic pump type of OMT targets the head, neck, thoracic region, lumbar and sacral regions, pelvis, arms, legs, and abdomen.

Also known as: Lymphatic Pump OMT
Treatment

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients being seen for respiratory illness symptoms at Geisinger 65-Forward Buckhorn, PA clinic for care.
  • Patients age of 65-100
  • New diagnosis of upper respiratory illness, sinusitis, bronchitis, or pneumonia during outpatient visit.

You may not qualify if:

  • Patients that have a healing fracture, including the spine, pelvis, shoulder, ribs, vertebrae, or extremities.
  • Patients actively receiving any type of cancer treatment
  • Patients with active or previously diagnosed liver disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger 65-Forward, Buckhorn

Bloomsburg, Pennsylvania, 17815, United States

RECRUITING

Related Publications (9)

  • Creasy C, Schander A, Orlowski A, Hodge LM. Thoracic and abdominal lymphatic pump techniques inhibit the growth of S. pneumoniae bacteria in the lungs of rats. Lymphat Res Biol. 2013 Sep;11(3):183-6. doi: 10.1089/lrb.2013.0007. Epub 2013 Sep 11.

    PMID: 24024572BACKGROUND
  • Hodge LM, Creasy C, Carter K, Orlowski A, Schander A, King HH. Lymphatic pump treatment as an adjunct to antibiotics for pneumonia in a rat model. J Am Osteopath Assoc. 2015 May;115(5):306-16. doi: 10.7556/jaoa.2015.061.

    PMID: 25938525BACKGROUND
  • Knott EM, Tune JD, Stoll ST, Downey HF. Increased lymphatic flow in the thoracic duct during manipulative intervention. J Am Osteopath Assoc. 2005 Oct;105(10):447-56.

    PMID: 16314677BACKGROUND
  • Saggio G, Docimo S, Pilc J, Norton J, Gilliar W. Impact of osteopathic manipulative treatment on secretory immunoglobulin a levels in a stressed population. J Am Osteopath Assoc. 2011 Mar;111(3):143-7.

    PMID: 21464262BACKGROUND
  • Noll DR, Degenhardt BF, Fossum C, Hensel K. Clinical and research protocol for osteopathic manipulative treatment of elderly patients with pneumonia. J Am Osteopath Assoc. 2008 Sep;108(9):508-16.

    PMID: 18806080BACKGROUND
  • Noll DR, Degenhardt BF, Johnson JC. Multicenter Osteopathic Pneumonia Study in the Elderly: Subgroup Analysis on Hospital Length of Stay, Ventilator-Dependent Respiratory Failure Rate, and In-hospital Mortality Rate. J Am Osteopath Assoc. 2016 Sep 1;116(9):574-87. doi: 10.7556/jaoa.2016.117.

    PMID: 27571294BACKGROUND
  • Yao S, Hassani J, Gagne M, George G, Gilliar W. Osteopathic manipulative treatment as a useful adjunctive tool for pneumonia. J Vis Exp. 2014 May 6;(87):50687. doi: 10.3791/50687.

    PMID: 24836893BACKGROUND
  • Noll DR. The short-term effect of a lymphatic pump protocol on blood cell counts in nursing home residents with limited mobility: a pilot study. J Am Osteopath Assoc. 2013 Jul;113(7):520-8. doi: 10.7556/jaoa.2013.003.

    PMID: 23843375BACKGROUND
  • Becker AD. Osteopathic treatment of the common cold. 1937. J Am Osteopath Assoc. 2001 Aug;101(8):461-3. No abstract available.

    PMID: 11534526BACKGROUND

MeSH Terms

Conditions

PneumoniaSinusitisBronchitisRespiration DisordersRespiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsLung DiseasesRespiratory Tract DiseasesParanasal Sinus DiseasesNose DiseasesOtorhinolaryngologic DiseasesBronchial DiseasesLung Diseases, Obstructive

Study Officials

  • Margaret Moore, DO

    Physician

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret Moore, DO

CONTACT

Andrew Ackerman, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomized into a control group and treatment group for their duration of the study upon informed consent. Control patients will not receive lymphatic pump OMT, while treatment patients will receive lymphatic pump therapy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2024

First Posted

July 10, 2024

Study Start

December 31, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

There is no direct intent to share individual participant data related to this study. However, per institute policy, records of data generated during this study will be de-identified and will be kept for at least 6 years within the institutes secured database and then destroyed. Prior to destruction, the data will have the OPTION of being used for other Geisinger institutional review board-approved research if appropriate.

Locations