Osteopathic Manipulation Makes a Neuropsychological Difference

NCT04058431 | Active Not Recruiting

• 1 other identifier: MWU2761
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change; Musculoskeletal Pain

Keywords

cognitive decline; pain; osteopathic manipulative treatment

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Osteopathic group

EXPERIMENTAL

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; Other: Control- No Intervention

Interventions

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

Osteopathic group

Control- No Intervention OTHER

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

Osteopathic group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Midwestern University: lead

Study Sites (1)

Midwestern Multispecialty Clinic

Downers Grove, Illinois, 60515, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Cognitive Dysfunction; Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• mireille rizkalla, phd

  Midwestern University

  PRINCIPAL INVESTIGATOR

• Katrina Ivkovic

  Midwestern University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: August 15, 2019
• Study Start: January 1, 2017
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)