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Active, Not Recruiting

NCT Number: NCT04058431

Osteopathic Manipulation Makes a Neuropsychological Difference

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Midwestern Multispecialty Clinic

Downers Grove, Illinois, 60515, United States

About this study

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:

  • To describe the neuropsychological (NP) characteristics of adults with pain within an osteopathic and allopathic setting
  • To correlate NP with clinical outcomes (pain severity, number/location of osteopathic lesions)
  • To determine if OMT is associated with improved NP function.
  • To use saliva to measure cytokine concentration of IL-1β,IL-6, IL-8, TNF-α
  • To correlate cytokine concentrations with clinical outcomes (pain severity, number/location of osteopathic lesions, NP)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Osteopathic manipulative treatment

Other

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

Control- No Intervention

Other

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

Primary outcomes

  1. neuropsychology change

    Time frame: baseline, week 8, week 12

    standardized assessment battery

  2. pain scale change

    Time frame: baseline, week 8, week 12

    1-10

  3. inflammatory markers change

    Time frame: baseline, week 8, week 12

    cortisol

  4. inflammatory marker

    Time frame: baseline, week 8, week 12

    TNF Alpha

  5. Inflammatory marker

    Time frame: baseline, week 8, week 12

    IL 6

Sponsors and collaborators

Lead sponsor

Midwestern University

Other

Registry information

Official study title

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

Acronym: BOD

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2019
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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