Osteopathic Manipulation Makes a Neuropsychological Difference

NCT ID: NCT04058431

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2026-09-30

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)

Conditions

Cognitive Change; Musculoskeletal Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Osteopathic Manipulative Treatment

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Control- No Intervention

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Midwestern University

OTHER

Sponsor Role: lead

Responsible Party

Mireille Rizkalla

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mireille rizkalla, phd

Role: PRINCIPAL_INVESTIGATOR

Midwestern University

Katrina Ivkovic

Role: STUDY_DIRECTOR

Midwestern University

Locations

Midwestern Multispecialty Clinic

Downers Grove, Illinois, United States

Countries

United States

Other Identifiers

MWU2761

Identifier Type: -

Identifier Source: org_study_id