NCT06565065

ImmunoBoost: The Lymphatic Osteopathic Manipulative Treatment Protocol Study

Lymphatic Osteopathic Manipulative Treatment Protocol for Healthy Individuals: A Crossover Self-Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Western University of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This clinical trial is a follow-up on a recent trial demonstrating an enhanced immune response in participants who received lymphatic osteopathic manipulative treatment (OMT) with each of their COVID-19 mRNA vaccinations. Similar immune enhancement was observed in a pilot study with OMT in conjunction with the Hepatitis B vaccine. Additionally, animal studies have shown that lymphatic pump OMT can cause transient increases in the movement of lymphatic fluid, immune cells, and signaling molecules throughout the body and bloodstream. These findings were further supported by in vitro studies on fibroblasts, where OMT led to significant increases in circulating cytokines. There are studies that suggest that combining physical exercise with vaccination can also improve immune responses. To parse out these effects observed in OMT and exercise studies and provide the mechanisms underlying the observed immune enhancements, this clinical trial will be conducted. This study is designed as a crossover, self-controlled, comparative effectiveness randomized clinical trial. A total of 30 healthy individuals who meet all inclusion/exclusion criteria will be recruited. Participants will then fill out a health questionnaire during the screening process to confirm their eligibility. Each participant will be randomly assigned to one of three intervention sequences to maintain blinding and control for order and sequencing effects. The intervention sequences are as follows: * 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 There will be a 3-week washout period between each intervention. Participants will complete the Global Physical Activity Questionnaire (GPAQ) survey to identify their current level of exercise at each visit. They will also be monitored for any adverse effects following each intervention. All treatment protocols will be done for a 12-minute timeframe per session. Participants will have three blood draws at each visit: at baseline, five minutes after intervention, and four hours after intervention. The primary outcome measures will include cytokine levels and circulating leukocyte levels, which will be compared across the different intervention sequences. This study aims to provide a deeper understanding of the mechanism by which lymphatic OMT alters the immune system. It will also compare these effects to the mechanisms of exercise.

Conditions

• Healthy

Interventions

Type	Name	Description
PROCEDURE	Osteopathic Manipulative Treatment (OMT)	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
OTHER	Sham Light Touch	A full standardized 12-minute session in which treaters will mimic various osteopathic manipulative techniques at specific anatomical locations without applying pressure or manipulation.
OTHER	Exercise Protocol	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.

Timeline

• Start date: 2025-07-14
• Primary completion: 2025-10-30
• Completion: 2025-12-30
• First posted: 2024-08-21
• Last updated: 2025-07-17

Locations

2 sites across 1 country: United States