Osteopathic Manipulative Treatment for Healthy Controls

DD
IF
Overseen ByIrv Freeman, J.D., Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Lake Erie College of Osteopathic Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether osteopathic manipulation, a hands-on treatment involving gentle pressure and stretching, can alter protein and fat levels in tears. Participants will receive either the actual treatment or a sham version for comparison. The study seeks individuals over 18 who understand the study and consent to this type of treatment.

As an unphased trial, it offers a unique opportunity to contribute to scientific understanding and potentially benefit from innovative treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that osteopathic manipulative treatment is safe?

Research has shown that osteopathic manipulative treatment (OMT) is generally safe. Studies have found no serious negative side effects. Mild side effects, such as temporary soreness, are rare and similar to those experienced by individuals who don't receive OMT. One study found that people receiving OMT were less likely to develop high-risk conditions. Overall, most people tolerate OMT well, and serious problems are uncommon.12345

Why are researchers excited about this trial?

Researchers are excited about Osteopathic Manipulative Treatment (OMT) because it offers a hands-on approach that targets specific body structures to potentially improve function and relieve discomfort. Unlike traditional treatments that may rely on medication to manage symptoms, OMT uses techniques like suboccipital release and sphenopalatine ganglion release to address issues directly at their source. This method could offer a non-invasive alternative with fewer side effects, focusing on the body's natural ability to heal and restore balance.

What evidence suggests that osteopathic manipulative treatment is effective for altering proteins and lipids in tears?

Research has shown that osteopathic manipulative treatment (OMT) can help with certain issues, such as long-term lower back pain. Specifically, individuals who received OMT for back pain reported greater relief and satisfaction compared to those who did not. However, evidence for OMT's effectiveness in treating other problems, like headaches or balance issues, remains less robust. While OMT is a low-cost and noninvasive option used by some doctors, the overall quality of evidence for its broader benefits is still considered low. This trial will compare the effects of OMT with a sham treatment to further evaluate its effectiveness.26789

Who Is on the Research Team?

DD

David Duriancik, Ph.D.

Principal Investigator

Lake Erie College of Osteopathic Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who understand the study, can give consent, and are willing to receive osteopathic manipulation. People with infected cuts or healthy individuals may be included.

Inclusion Criteria

I am older than 18 years.
I understand the study and have agreed to take part.
* Individuals willing and able to receive OMT

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive osteopathic manipulative treatment including suboccipital 4-step release, occipital mastoid suture release, and sphenopalatine ganglion release

1 week
3 visits (in-person)

Follow-up

Participants are monitored for changes in tear protein concentration and other biomarkers

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Osteopathic Manipulative Treatment

Trial Overview

The study compares real osteopathic manipulative treatment (OMT) to a sham (fake) procedure to see if OMT changes protein levels in tears. Participants are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Osteopathic Manipulative TreatmentExperimental Treatment1 Intervention
Group II: ShamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lake Erie College of Osteopathic Medicine

Lead Sponsor

Trials
9
Recruited
570+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/12838090/

Osteopathic manipulative treatment for chronic low back pain

the patients who received osteopathic manipulative treatment reported greater improvements in back pain, greater satisfaction with back care throughout the ...

An overview of systematic reviews on the efficacy and ...

Based on the available evidence, the results showed that OMT does not reduce impairment to daily living in patients with vertigo/balance disorders. The evidence ...

Osteopathic Health Outcomes in Chronic Low Back Pain ...

Outcomes of osteopathic manual treatment for chronic low back pain according to baseline pain severity: results from the OSTEOPATHIC Trial. Man Ther. 2013 ...

Osteopathic manipulative treatment: A systematic review ...

The comparative effectiveness studies reported outcomes for varied health conditions and the majority (n = 6) demonstrated a high risk of bias.

Osteopathic Manipulative Medicine: A Brief Review of the ...

The lower cost of osteopathic medicine, their noninvasive methodologies, and their proven efficacy in promoting full-body healing is a testament ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/27802555/

PROMOTE Study: Safety of Osteopathic Manipulative ...

High-risk status was less likely to develop in participants who received OMT (95% CI, 0.16-0.91; P=.03). The OMT protocol also did not increase ...

Defining the landscape of patient harm after osteopathic ...

The majority of post-OMT AEs observed in the primary clinical literature were of mild severity. Modeling of the combined dataset on post-OMT AEs ...

Efficacy and safety of osteopathic manipulative treatment

Conflicting results were derived from the primary studies. In the intergroup analysis, OMT was not effective in reducing pain in the majority of the trials.

OMM and Evidence Based Medicine - AOA Board Certification

OMT resulted in significantly reduced postoperative pain; improved pulmonary function; increased cardiac index; decreased hospital length of stay