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

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Patients with pain commonly experience cognitive impairment. While symptoms of pain are effectively treated with osteopathic manipulative treatment (OMT), the cognitive piece is vastly ignored. Pain-induced cognitive dysfunction can be severe and is particularly apparent in working memory and attention. There is good reason to also expect cognitive responsiveness to OMT. Previous research has already reported related psychiatric outcomes, including relief from stress, self-perception and anxiety, suggesting that OMT may produce more global effects on cortical processing than currently thought.

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.

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

Research on osteopathic manipulative treatment (OMT) suggests that while it is a popular approach, the frequency and severity of any adverse events (unwanted effects) are not well-defined. There is no established benchmark for patient safety, indicating a need for more detailed safety data. ^{1 2 3 4 5}

How is Osteopathic Manipulative Treatment (OMT) different from other treatments for cognitive impairment?

Osteopathic Manipulative Treatment (OMT) is unique because it involves hands-on techniques to improve body function, which may indirectly benefit cognitive function, unlike other treatments that often focus directly on brain stimulation or cognitive exercises. This approach is part of a broader category of non-pharmacological therapies that aim to enhance overall well-being and potentially improve cognitive symptoms. ^{6 7 8 9 10}

What data supports the effectiveness of Osteopathic Manipulative Treatment (OMT) for cognitive impairment?

While there is no direct evidence from the provided research articles about the effectiveness of Osteopathic Manipulative Treatment (OMT) for cognitive impairment, non-pharmacological therapies, in general, have been shown to help alleviate symptoms of mild cognitive impairment (MCI). This suggests that treatments like OMT, which are non-drug therapies, might have potential benefits for cognitive issues. ^{8 11 12 13 14}

Who Is on the Research Team?

Katrina Ivkovic

Principal Investigator

Midwestern University

mireille rizkalla, phd

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 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]

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]

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]

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]

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]

Citations

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

Caring for the caregivers. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation practice patterns: a survey of American Hospital Association Rehabilitation Programs. [2019]

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

Comparison of multiple interventions for older adults with Alzheimer disease or mild cognitive impairment: A PRISMA-compliant network meta-analysis. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review and network meta-analysis comparing various non-pharmacological treatments for older people with mild cognitive impairment. [2023]

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

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

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

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

7. England pubmed.ncbi.nlm.nih.gov

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

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

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

Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. [2022]

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

Alzheimer Disease and Related Cognitive Impairment in Older Adults: A Narrative Review of Screening, Prevention, and Management for Manual Therapy Providers. [2023]

12. England 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. [2018]

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

Using the Omaha System to examine outpatient rehabilitation problems, interventions, and outcomes between clients with and without cognitive impairment. [2019]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of multi-component non-pharmacological interventions on cognition in participants with mild cognitive impairment: A systematic review and meta-analysis. [2023]