ImmunoBoost: The Lymphatic Osteopathic Manipulative Treatment Protocol Study

NCT06565065 | Recruiting

• 1 other identifier: P24/IRB/002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to determine whether osteopathic manipulative treatment (OMT) enhances immune system readiness in healthy adults compared to exercise or sham light treatment. Specifically, the goal of this study is to assess circulating immune cells and signaling molecules in the blood in response to these various treatments. It aims to compare: Complete Blood Counts (CBC) and blood immune signaling molecule levels in healthy adults in response to OMT, sham light touch, and exercise, with measurements taken at multiple time points. Researchers will compare immune blood cells and signaling molecules in response to OMT versus sham light touch and exercise within the same group of healthy adults measured at three time points for each of the three total visits. Participants will do a 15-minute OMT session, a 15-minute light sham session, or a 15-minute exercise session at each of their three separate visits (they will do one of each over the course of their 3 appointments in random order). They will have three blood draws taken at each of those three visits. They will also fill out a Global Physical Activity Questionnaire (GPAQ) survey to assess their level of physical activity throughout the study.

Conditions

Healthy

Keywords

Osteopathic Manipulative Treatment; Lymphatic Pump Treatment; Immune System; OMT; Complete Blood Count; Cytokines

Outcome Measures

Primary Outcomes (1)

• Complete Blood Count (CBC) with differential

  CBC with differential will be evaluated to identify the number of circulating plasma leukocytes for each intervention for each of the three interventions at three time points for each visit/intervention. This test will help us identify levels of erythrocytes, platelets, and leukocytes, including neutrophils, lymphocytes, monocytes, eosinophils, and basophils. This will be compared across time points for OMT, sham treatment, and exercise.

  Baseline to 5 minutes post-intervention to 4 hours post-intervention.

Secondary Outcomes (2)

• Pro-Inflammatory cytokine profiling

  Baseline to 5 minutes post-intervention to 4 hours post-intervention.

• Evaluation of safety based on reported adverse events

  Through study completion, an average of 6 weeks.

Study Arms (3)

Order 1 - Day 0: OMT, Week 3: Sham, Week 6: Exercise

EXPERIMENTAL

Osteopathic Manipulative Treatment (OMT) followed by a 3-week washout period and then: Sham protocol followed by a 3-week washout period and then: Exercise protocol.

Procedure: Osteopathic Manipulative Treatment (OMT); Other: Sham Light Touch; Other: Exercise Protocol

Order 2 - Day 0: Sham, Week 3: OMT, Week 6: Exercise

EXPERIMENTAL

Sham protocol followed by a 3-week washout period and then: Osteopathic Manipulative Treatment (OMT) followed by a 3-week washout period and then: Exercise protocol.

Procedure: Osteopathic Manipulative Treatment (OMT); Other: Sham Light Touch; Other: Exercise Protocol

Order 3 - Day 0: Exercise, Week 3: OMT, Week 6: Sham

EXPERIMENTAL

Exercise protocol followed by a 3-week washout period and then: Osteopathic Manipulative Treatment (OMT) followed by a 3-week washout period and then: Sham protocol.

Procedure: Osteopathic Manipulative Treatment (OMT); Other: Sham Light Touch; Other: Exercise Protocol

Interventions

Osteopathic Manipulative Treatment (OMT) PROCEDURE

A full standardized lymphatic protocol will be performed, including thoracic inlet left and right, thoracoabdominal release, pelvic diaphragm release, pedal pump, splenic pump, and abdominal lymphatic pump. This treatment will be done by systematically working down and back up. The protocol will last a total of 12 minutes for each participant

Order 1 - Day 0: OMT, Week 3: Sham, Week 6: Exercise; Order 2 - Day 0: Sham, Week 3: OMT, Week 6: Exercise; Order 3 - Day 0: Exercise, Week 3: OMT, Week 6: Sham

Sham Light Touch OTHER

A full standardized 12-minute session in which treaters will mimic various osteopathic manipulative techniques at specific anatomical locations without applying pressure or manipulation.

Order 1 - Day 0: OMT, Week 3: Sham, Week 6: Exercise; Order 2 - Day 0: Sham, Week 3: OMT, Week 6: Exercise; Order 3 - Day 0: Exercise, Week 3: OMT, Week 6: Sham

Exercise Protocol OTHER

A full standardized moderate-intensity physical activity as defined by the Centers for Disease Control (CDC). Target heart rate for moderate-intensity exercise should be between 64 and 76% of maximum heart rate. To estimate age-related heart rate, subjects' age will be subtracted from 220. Then, that number will be multiplied by 75%, which will be standardized across all subjects in the study. Heart rate will be monitored with the use of an attached pulse-ox monitor. Treadmill speed will be adjusted accordingly so that each subject maintains a heart rate of 75% of their maximum heart rate. A brisk walk will be done on a flat treadmill and no incline will be utilized. Subjects will be allowed a minute of warm-up to get to the appropriate pace/target heart rate.

Order 1 - Day 0: OMT, Week 3: Sham, Week 6: Exercise; Order 2 - Day 0: Sham, Week 3: OMT, Week 6: Exercise; Order 3 - Day 0: Exercise, Week 3: OMT, Week 6: Sham

Eligibility Criteria

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

You may qualify if:

• Individuals must be 18 years or older.
• Individuals must provide informed consent.
• Individuals must be healthy with a BMI under 30, with no primary or secondary immune deficiency or autoimmune disease/must not be immunocompromised.
• Individuals must not be using or recently have used any immune-altering medications such as corticosteroids, cyclosporin, tacrolimus, and pimecrolimus
• Individuals must not have had lymphatic OMT or other physical manipulation such as acupuncture, physical therapy, chiropractic, or massage therapy in the previous four weeks before study enrollment.
• Individuals must have the ability to receive OMT with lymphatic techniques.
• Individuals must be able to tolerate 12 minutes of moderate physical activity.
• Individuals must not be pregnant or breastfeeding.
• Individuals must not have had a splenectomy or other spleen or oncologic surgery within the past 6 months.
• Individuals must be infection-free for the past 6 weeks before starting the study and have not received any immunizations within the past 6 weeks.
• Individuals must be willing to avoid strenuous activity at least 24 hours before each visit.
• Individuals must be willing to abstain from moderate to intense activity in the 4 hours between their 2nd blood draw and their final blood draw at each of their three visits.

You may not qualify if:

• Individuals are younger than 18 years of age.
• Individuals who do not provide informed consent.
• Individuals with a BMI over 30, or with primary or secondary immune deficiency or autoimmune disease or is immunocompromised.
• Individuals using or recently have used any immune-altering medications such as corticosteroids, cyclosporin, tacrolimus, and pimecrolimus
• Individuals who have had lymphatic OMT or other physical manipulation such as acupuncture, physical therapy, chiropractic, or massage therapy in the previous four weeks before study enrollment.
• Individuals who don't have the ability to receive OMT with lymphatic techniques.
• Individuals who cannot tolerate 12 minutes of moderate physical activity.
• Individuals who are pregnant or breastfeeding.
• Individuals who have had a splenectomy or other spleen or oncologic surgery within the past 6 months.
• Individuals who have had an infection in the 6 weeks before starting the study and or have received any immunizations within the past 6 weeks.
• Individuals not willing to avoid strenuous activity at least 24 hours before each visit.
• Individuals not willing to abstain from moderate to intense activity in the 4 hours between their 2nd blood draw and their final blood draw at each of their three visits.

Sponsors & Collaborators

• Western University of Health Sciences: lead
• American Osteopathic Foundation: collaborator

Study Sites (2)

Western University of Health Sciences

Pomona, California, 91766, United States

NOT YET RECRUITING

Western University of Health Sciences

Pomona, California, 91766, United States

RECRUITING

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Brian Loveless, DO

  Professor of NMM/OMM and Chief Medical Officer of WesternU Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Loveless, DO

CONTACT

909-469-8223; bloveless@westernu.edu

Eric S Martinez, BS

CONTACT

909-469-5224; ericmartinez@westernu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will not be directly told of the order of their treatment or workout sessions in an attempt to blind between OMT and sham treatment. Investigators will be blinded to the order in which participants receive their treatment besides the direct treater and the research assistant. Outcome assessors and statisticians will only analyze coded participant data.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer, WesternU Health/ Professor or OMM/MMM WesternU COMP

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: July 14, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)