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Osteopathic Manipulation Makes a Neuropsychological Difference

Examining Osteopathic Manipulation on Making a Neuropsychological Brain of Difference in Adults With Pain: A BOD Study Protocol and Rationale for a New Approach

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04058431
Acronym
BOD
Enrollment
100
Registered
2019-08-15
Start date
2017-01-31
Completion date
2026-09-30
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Change, Musculoskeletal Pain

Keywords

cognitive decline, pain, osteopathic manipulative treatment

Brief summary

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.

Detailed description

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. 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. The current study is designed to extend previous research in several ways: 1. To describe the neuropsychological (NP) characteristics of adults with pain within an osteopathic and allopathic setting 2. To correlate NP with clinical outcomes (pain severity, number/location of osteopathic lesions) 3. To determine if OMT is associated with improved NP function. 4. To use saliva to measure cytokine concentration of IL-1β,IL-6, IL-8, TNF-α 5. To correlate cytokine concentrations with clinical outcomes (pain severity, number/location of osteopathic lesions, NP)

Interventions

OTHEROsteopathic Manipulative Treatment

Osteopathic manipulative treatment (OMT) is defined as the therapeutic application of manually guided forces by an osteopathic physician to improve physiologic function and/or support homeostasis that has been altered by somatic dysfunction. Somatic (body framework) dysfunction or altered function of related components is observed in the skeletal, arthrodial and myofascial structures, and their related vascular, lymphatic, and neural elements. Techniques can use a direct method where the restrictive barrier is engaged and a final activating force is applied to correct the somatic dysfunction, or an indirect method where the restrictive barrier is disengaged and the dysfunctional body part is moved away from the restrictive barrier until tissue tension is equal in one or all planes and directions

OTHERControl- No Intervention

This group will refrain from getting OMT while in the study.

Sponsors

Midwestern University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 40 years of age or older; 2. seeking treatment for acute or chronic pain (neck, thoracic, shoulder, back) 3. gives a positive response to the item, Have you had thinking problems because of your pain?; 4. agree to forego extra-trial manipulation (e.g., massage, chiropractic, physical therapy); 5. Score \> 23 on the Telephone Interview for Cognitive Status; 6. written informed consent.

Exclusion criteria

1. recent (\< 2 month) or planned surgery within the duration of the study; 2. use of medication that could interfere with cytokine measurements; 3. recent (\< 2 month) changes to psychotropic medication within the duration of the study; 4. history of manipulation within the past six months. 5. diagnosed neurocognitive disorders; 6. contraindication to receiving OMT.

Design outcomes

Primary

MeasureTime frameDescription
inflammatory markerbaseline, week 8, week 12TNF Alpha
neuropsychology changebaseline, week 8, week 12standardized assessment battery
pain scale changebaseline, week 8, week 121-10
inflammatory markers changebaseline, week 8, week 12cortisol
Inflammatory markerbaseline, week 8, week 12IL 6

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026