Osteopathic Manipulation for Cognitive Impairment

(BOD Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Midwestern University

Must not be taking: Psychotropics, Cytokine-interfering

Disqualifiers: Recent surgery, Neurocognitive disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether osteopathic manipulative treatment (OMT), a hands-on therapy, can improve cognitive function in individuals experiencing thinking problems due to pain. Chronic pain often leads to issues with memory and attention, and OMT has already shown promise in reducing pain and stress. The study aims to determine if these benefits extend to mental processes. Individuals dealing with pain in areas like the neck, back, or shoulders, and who feel that their pain affects their thinking, might be suitable for this trial. Participants must agree not to receive other similar treatments during the study. As an unphased trial, this study offers a unique opportunity to explore new benefits of OMT for cognitive function.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use medications that interfere with cytokine measurements or have recent changes to psychotropic medications. It's best to discuss your specific medications with the trial team.

What prior data suggests that osteopathic manipulative treatment is safe for cognitive impairment?

Research has shown that osteopathic manipulative treatment (OMT) is generally safe and well-tolerated. Studies have found that OMT can reduce inflammation and activate the parasympathetic system, which helps relax the body. These effects contribute to its safety.

In past studies, OMT has been used to help manage pain and improve symptoms in various conditions. No major reports of negative side effects have emerged, indicating that patients usually handle the treatment well. Since OMT involves hands-on techniques, trained professionals must perform it to ensure safety.

Overall, evidence supports OMT as a promising and safe treatment option for those considering it for cognitive issues related to pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for cognitive impairment often involve medications that aim to enhance neurotransmitter activity in the brain. However, Osteopathic Manipulative Treatment (OMT) offers a different approach by focusing on the body's structure and function. Researchers are excited about OMT because it involves personalized manual techniques that aim to improve blood flow, reduce tension, and promote overall bodily balance, potentially benefiting brain function without the use of drugs. This non-invasive method provides a holistic alternative, which could be appealing for those seeking treatments with fewer side effects.

What evidence suggests that osteopathic manipulative treatment might be an effective treatment for cognitive impairment?

Research has shown that Osteopathic Manipulative Treatment (OMT), which participants in this trial will receive, can help manage pain and might also benefit brain function. Although direct proof of its effects on the brain is not yet available, studies have found that OMT can improve symptoms like stress, self-esteem, and anxiety, which relate to brain function. This suggests that OMT might support overall brain health. Some research also hints at its potential in helping with diseases that affect the brain. These findings suggest that OMT could assist with cognitive issues linked to pain. ^{1 2 6 7 8}

Who Is on the Research Team?

mireille rizkalla, phd

Principal Investigator

Midwestern University

Katrina Ivkovic

Principal Investigator

Midwestern University

Are You a Good Fit for This Trial?

This trial is for individuals over 40 seeking treatment for acute or chronic musculoskeletal pain (like neck, shoulder, or back pain) who feel it's affecting their thinking. They must not have had any recent surgery, manipulation treatments like massage or chiropractic work in the past six months, and should not be on certain medications.

Inclusion Criteria

Agree to forego extra-trial manipulation (e.g., massage, chiropractic, physical therapy)

Written informed consent

You scored higher than 23 on a test to check how well you can remember things and think clearly over the phone.

Exclusion Criteria

You cannot take the prescribed medication.

You are taking medication that could affect the measurement of certain substances in your body.

You changed your mental health medication within the last 2 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive osteopathic manipulative treatment (OMT) for 8 weeks, with individualized techniques applied based on patient needs

8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain scale, inflammatory markers, and neuropsychology

4 weeks

Visits at week 8 and week 12 (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Osteopathic Manipulative Treatment

Trial Overview The study is testing if Osteopathic Manipulative Treatment (OMT), a hands-on therapy often used to treat pain, can also improve cognitive functions such as memory and attention in patients with musculoskeletal pain.

How Is the Trial Designed?

Group I: Osteopathic group Experimental Treatment 2 Interventions

Treatment will be compromised of 8 weeks of standard care plus OMT. Each physician will maintain the same patient at recurring sessions. Osteopathic treatment is performed for 30 minutes and the techniques applied are highly individualized to the patient needs (i.e., techniques are selected based on structure/function, and techniques change over time based on treatment response). In an effort to standardize treatment, we will limit the study protocol to the following designated techniques: facilitated positional release treatment, high velocity low amplitude treatment, articulatory treatment, strain-counterstrain, muscle energy treatment, myofascial release treatment, soft tissue treatment.

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

Approved in United States as OMT for:

• Positional plagiocephaly
• Deformational plagiocephaly

Approved in European Union as OMT for:

• Positional plagiocephaly
• Deformational plagiocephaly

Who Is Running the Clinical Trial?

Midwestern University

Lead Sponsor

Trials

24

Recruited

3,500+

Published Research Related to This Trial

Managed care organizations (MCOs) should implement integrated care strategies for Alzheimer's disease (AD) to manage rising costs and improve patient outcomes, focusing on both pharmacologic and non-pharmacologic treatments.

Evidence-based guidelines suggest that MCOs can enhance AD care through standardized protocols for diagnosis and treatment, education for healthcare providers, and integrated case management, which may help prevent costly hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managed care decisions in Alzheimer's disease. Fillit, HM.[2007]

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]

Cranial osteopathic manipulative medicine (OMM) shows potential benefits in reducing pain, improving sleep patterns, and enhancing autonomic nervous system function based on a review of 8 studies, including 7 randomized controlled trials.

However, the evidence is heterogeneous and of moderate quality, indicating that more rigorous research is necessary to establish definitive conclusions about the efficacy of cranial OMM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. Jäkel, A., von Hauenschild, P.[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]

Repetitive transcranial magnetic stimulation (rTMS) significantly improved cognitive function in older patients with mild to moderate Alzheimer's disease, based on a meta-analysis of seven randomized controlled trials involving 194 participants.

rTMS is considered a safe and well-tolerated alternative intervention for cognitive impairment, showing a moderate effect size in enhancing cognition compared to sham treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation on improvement of cognition in elderly patients with cognitive impairment: a systematic review and meta-analysis. Cheng, CPW., Wong, CSM., Lee, KK., et al.[2018]

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 systematic review of 23 studies found that the majority of adverse events (AEs) following osteopathic manipulative treatment (OMT) were mild, accounting for 98% of reported AEs, indicating a generally safe profile for this treatment.

The study established a patient safety benchmark for post-OMT AEs at 1.0 AEs per 100 post-OMT interval-days, providing a reference point for future research and comparisons in patient safety within osteopathic manipulative medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model. Unger, MD., Barr, JN., Brower, JA., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11241316/

The Effects of Osteopathic Manipulative Treatment on Brain ... Abstract. Osteopathic manipulative treatment (OMT) is a hands-on therapy aiming to achieve the global homeostasis of the patient.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9462953/

Osteopathic Manipulative Treatment and the Management of ... Efficacy of osteopathic manipulative treatment of female patients with migraine: results of a randomized controlled trial. Voigt K ...

3. cureus.com cureus.com/articles/402906-application-of-osteopathic-manipulative-treatment-omt-in-neurodegenerative-disorders-a-scoping-review

Application of Osteopathic Manipulative Treatment (OMT) ... An additional non-pharmacologic therapy being investigated to manage neurodegenerative diseases is osteopathic manipulative treatment (OMT).

4. withpower.com withpower.com/trial/osteopathic-manipulation-for-cognitive-impairment-b7b08

Osteopathic Manipulation for Cognitive Impairment · Info for ... While there is no direct evidence from the provided research articles about the effectiveness of Osteopathic Manipulative Treatment (OMT) for cognitive ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405844025019516

The role of osteopathic manipulative treatment in ... Osteopathic manipulative treatment (OMT) should be considered a promising holistic treatment to manage better pain and symptoms related to the chronic stages ...

6. mdpi.com mdpi.com/2227-9032/12/13/1353

The Effects of Osteopathic Manipulative Treatment on Brain ... Osteopathic manipulative treatment (OMT) is a hands-on therapy aiming to achieve the global homeostasis of the patient.

7. journals.lww.com journals.lww.com/md-journal/fulltext/2017/03240/osteopathic_manipulative_treatment_showed.43.aspx

Osteopathic manipulative treatment showed reduction of... Generally, in-vitro and in-vivo research suggested that osteopathic manipulative treatment (OMT) has anti-inflammatory and parasympathetic effects. Although ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02750566

Comparing the Effect of Osteopathic Manipulative Medicine ... Osteopathic manipulative treatment (OMT) is defined in the Glossary of Osteopathic Terminology as "the therapeutic application of manually guided forces by an ...