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

Trial Summary

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 data supports the effectiveness of the treatment Osteopathic Manipulative Treatment (OMT) for immune boosting in healthy adults?

Research indicates that Osteopathic Manipulative Treatment (OMT) is a beneficial and noninvasive option for various conditions, suggesting it may have potential health benefits. However, specific studies on its effectiveness for immune boosting in healthy adults are limited. ^{1 2 3 4 5}

Is osteopathic manipulative treatment (OMT) generally safe for humans?

Research indicates that osteopathic manipulative treatment (OMT) is generally safe for humans, with few adverse events reported. However, specific safety data for different conditions and populations may vary. ^{1 3 4 6 7}

How is osteopathic manipulative treatment (OMT) unique for boosting the immune system?

Osteopathic manipulative treatment (OMT) is unique because it is a hands-on, noninvasive therapy that may enhance immune function by improving lymphatic movement, which is different from conventional drug-based approaches. This treatment is based on the principles of osteopathic medicine, focusing on the body's natural ability to heal itself. ^{1 2 8 9 10}

What is the purpose of this trial?

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.

Research Team

Brian Loveless, DO

Principal Investigator

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

Eligibility Criteria

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

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

Individuals must provide informed consent

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Characteristics and treatment of geriatric patients in an osteopathic neuromusculoskeletal medicine clinic. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Utilization and reimbursement trends of osteopathic manipulative treatment for Medicare patients: 2000-2019. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews. [2022]

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

Preliminary findings on the use of osteopathic manipulative treatment: outcomes during the formation of the practice-based research network, DO-Touch.NET. [2015]

5. Scotland pubmed.ncbi.nlm.nih.gov

Quality of life in patients referring to private osteopathic clinical practice: a prospective observational study. [2015]

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

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

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

Incidence of iatrogenesis associated with osteopathic manipulative treatment of pediatric patients. [2006]

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

Characteristics and Treatment of Pediatric Patients in an Osteopathic Manipulative Medicine Clinic. [2022]

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

Osteopathic medical students' beliefs about osteopathic manipulative treatment at 4 colleges of osteopathic medicine. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Augmentation of immune response to vaccinations through osteopathic manipulative treatment: a study of procedure. [2023]