Osteopathic Manipulative Treatment for Immune Boosting in Healthy Adults

Overseen By Brian Loveless, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University of Health Sciences

Must not be taking: Corticosteroids, Cyclosporin, Tacrolimus, Pimecrolimus

Disqualifiers: BMI over 30, Autoimmune disease, Immunocompromised, Pregnancy, 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: 4

Duration: 9 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether osteopathic manipulative treatment (OMT), which uses hands-on techniques to improve body function, can boost the immune system in healthy adults. It compares the effects of OMT with light touch (a sham treatment) and exercise by measuring immune cells and signals in the blood. Participants receive each type of treatment across three visits, with blood samples taken to track changes. This trial suits healthy individuals who haven't had recent infections or certain medical treatments and can tolerate moderate exercise. As an unphased trial, it offers participants the chance to contribute to foundational research that could enhance understanding of immune health.

Will I have to stop taking my current medications?

The trial requires that you must not be using or have recently used any immune-altering medications like corticosteroids, cyclosporin, tacrolimus, and pimecrolimus. If you are on these medications, you would need to stop taking them to participate.

What prior data suggests that osteopathic manipulative treatment is safe for immune boosting in healthy adults?

Research has shown that osteopathic manipulative treatment (OMT) is generally very safe. Studies have found no serious side effects linked to OMT. About 12% of people might experience mild, temporary soreness afterward, but this resolves quickly. OMT is noninvasive, meaning it doesn't involve surgery, and it works by helping the body's systems heal. This makes it a safe option for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Osteopathic Manipulative Treatment (OMT) for its potential to boost the immune system naturally. Unlike traditional medications that might involve pharmaceuticals or supplements, OMT uses hands-on techniques to improve the body's function and health. This method could offer a drug-free alternative to enhancing immune response, which is particularly appealing for those seeking holistic approaches. Additionally, the trial explores the effects of combining OMT with exercise and sham treatments, aiming to uncover new insights into how these interactions can optimize health benefits.

What evidence suggests that this trial's treatments could be effective for boosting the immune system in healthy adults?

This trial will evaluate the effects of Osteopathic Manipulative Treatment (OMT) on the immune system in healthy adults. Studies have shown that OMT might benefit the immune system. For example, a small study suggested that OMT could help vaccines work faster by speeding up the body's antibody response. Research also shows that OMT can support overall healing by affecting the immune, nervous, lymphatic, and blood systems. Although these findings are promising, more research is needed to fully understand how OMT affects the immune system. ^{1 2 3 5 6}

Who Is on the Research Team?

Brian Loveless, DO

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in how different treatments might affect their immune system. Participants will be involved in three separate sessions, each including a unique treatment: osteopathic manipulative treatment (OMT), sham light touch, or exercise. They must complete a physical activity survey and agree to blood draws during visits.

Inclusion Criteria

Individuals must provide informed consent

I am not currently using, nor have I recently used, any immune-altering medications.

I am healthy, my BMI is under 30, and I do not have immune or autoimmune conditions.

Exclusion Criteria

Individuals not willing to avoid strenuous activity at least 24 hours before each visit

I have a BMI over 30, or an immune system condition.

I am currently using or have recently used medications that affect my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo three different interventions: OMT, sham light touch, and exercise, each followed by a 3-week washout period

9 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Osteopathic Manipulative Treatment (OMT)

Trial Overview The study tests the impact of OMT on immune readiness compared to exercise and sham light touch by measuring changes in blood cells and immune signals at multiple times after these treatments. Each participant experiences all three interventions across three visits.

How Is the Trial Designed?

Group I: Order 3 - Day 0: Exercise, Week 3: OMT, Week 6: Sham Experimental Treatment 3 Interventions

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.

Group II: Order 2 - Day 0: Sham, Week 3: OMT, Week 6: Exercise Experimental Treatment 3 Interventions

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.

Group III: Order 1 - Day 0: OMT, Week 3: Sham, Week 6: Exercise Experimental Treatment 3 Interventions

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.

Osteopathic Manipulative Treatment (OMT) is already approved in United States, European Union for the following indications:

Approved in United States as Osteopathic Manipulative Treatment for:

• Carpal Tunnel Syndrome

Approved in European Union as Osteopathic Manipulative Treatment for:

• Carpal Tunnel Syndrome

Who Is Running the Clinical Trial?

Western University of Health Sciences

Lead Sponsor

Trials

25

Recruited

1,300+

American Osteopathic Foundation

Collaborator

Trials

3

Recruited

140+

Published Research Related to This Trial

A survey of 491 first- and second-year osteopathic medical students revealed that a strong majority (76%-95%) agree with osteopathic philosophy, particularly those with prior exposure to osteopathic manipulative treatment (OMT).

Students' intentions to use OMT in their future practice were influenced by their reasons for choosing osteopathic medicine, with those motivated by a general desire to be a physician showing less agreement with osteopathic principles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic medical students' beliefs about osteopathic manipulative treatment at 4 colleges of osteopathic medicine. Draper, BB., Johnson, JC., Fossum, C., et al.[2022]

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 study of 1,238 geriatric patients receiving osteopathic manipulative treatment (OMT) over three years, the majority presented with neuromusculoskeletal concerns, particularly back issues, and showed significant improvement in their conditions after treatment.

The most commonly used OMT techniques were consistent with national practices, with muscle energy techniques being the most frequently documented, while the use of high-velocity, low-amplitude techniques decreased with age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and treatment of geriatric patients in an osteopathic neuromusculoskeletal medicine clinic. King, AA., Cox, J., Bhatia, S., et al.[2021]

A review of medical records from 346 pediatric patients receiving osteopathic manipulative treatment (OMT) found no serious complications, indicating that OMT is a safe treatment option for children.

While 9% of patients experienced minor treatment-associated aggravations (worsening of symptoms), there were no significant differences in outcomes based on gender, suggesting that OMT can be safely administered by trained physicians in the pediatric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of iatrogenesis associated with osteopathic manipulative treatment of pediatric patients. Hayes, NM., Bezilla, TA.[2006]

Between 2000 and 2019, the utilization of osteopathic manipulative treatment (OMT) among Medicare beneficiaries decreased by 24.5%, indicating a decline in this noninvasive treatment option despite its established benefits.

The decrease in OMT usage is likely linked to lower reimbursement rates for OMT services, which may have disincentivized physicians, alongside a reduction in residency programs offering OMT training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization and reimbursement trends of osteopathic manipulative treatment for Medicare patients: 2000-2019. Starr, EG., Smith, JF., Hanson, RB., et al.[2023]

A study of 537 pediatric patients receiving osteopathic manipulative treatment (OMT) revealed that musculoskeletal issues were the most common complaints in children aged 6 and older, while younger children often presented with feeding difficulties and colic.

The most frequently used OMT technique was myofascial release, and the study highlighted significant differences in somatic dysfunction assessments based on payment methods, suggesting that insurance status may influence the extent of treatment provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Treatment of Pediatric Patients in an Osteopathic Manipulative Medicine Clinic. Kaiser, G., Degenhardt, BF., Michael Menke, J., et al.[2022]

Osteopathic manipulative treatment (OMT) shows promising effectiveness in reducing pain and improving function for conditions like acute and chronic non-specific low back pain, chronic non-specific neck pain, and chronic non-cancer pain, based on a review of nine systematic reviews and meta-analyses involving 3740 participants.

There is limited and inconclusive evidence regarding the efficacy of OMT for pediatric conditions, primary headaches, and irritable bowel syndrome, and no adverse events were reported in most studies, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews. Bagagiolo, D., Rosa, D., Borrelli, F.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12302173/

COVID-19 mRNA vaccine immune response to the addition ... A pilot study suggested OMT combined with Hepatitis B vaccines speeds antibody responses. OMT's role in the COVID-19 mRNA vaccine uptake ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06565065

ImmunoBoost: The Lymphatic Osteopathic Manipulative ... The primary outcome measures will include cytokine levels and circulating leukocyte levels, which will be compared across the different intervention sequences.

3. cureus.com cureus.com/posters/2209-a-systematic-review-of-the-effects-of-osteopathic-manipulation-on-the-immune-system

A Systematic Review of The Effects of Osteopathic ... More specifically, the degree to which OMT therapy benefits patients with a compromised immune system remains unclear. The purpose of this study ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1360859225000993

An overview of systematic reviews on the efficacy and ... Based on moderate quality of evidence, osteopathic treatment was an effective means of reducing pain and partially improving physical function in adults.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9143587/

Osteopathic Manipulative Medicine: A Brief Review of the ... OMT is lower-cost, noninvasive, and highly effective in promoting full-body healing by targeting the nervous, lymphatic, immune, and vascular ...

6. wellnessobgyn.com wellnessobgyn.com/does-osteopathic-manipulative-treatment-work/

does osteopathic manipulative treatment work? 7 ... OMT is remarkably safe. Clinical trials report no serious adverse events, with only about 12% of patients experiencing mild, temporary soreness following ...