Osteopathic Manipulation Makes a Neuropsychological Difference (BOD)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Musculoskeletal Pain; Cognitive Change
• Intervention / Treatment: Other: Osteopathic Manipulative Treatment; Other: Control- No Intervention

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)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Downers Grove, Illinois, United States, 60515
      • Midwestern Multispecialty Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Osteopathic group; 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.

Other: Osteopathic 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; Other: Control- No Intervention; This group will refrain from getting OMT while in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neuropsychology change	standardized assessment battery	baseline, week 8, week 12
pain scale change	1-10	baseline, week 8, week 12
inflammatory markers change	cortisol	baseline, week 8, week 12
inflammatory marker	TNF Alpha	baseline, week 8, week 12
Inflammatory marker	IL 6	baseline, week 8, week 12

Collaborators and Investigators

• Sponsor: Midwestern University
• Investigators: Principal Investigator: mireille rizkalla, phd, Midwestern University; Study Director: Katrina Ivkovic, Midwestern University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: pain; cognitive decline; osteopathic manipulative treatment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Cognitive Dysfunction; Musculoskeletal Pain; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Musculoskeletal Manipulations; Manipulation, Osteopathic
• Other Study ID Numbers: MWU2761

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No