Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Osteopathic Manipulation Makes a Neuropsychological Difference (BOD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04058431
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Mireille Rizkalla, Midwestern University

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.

Condition or disease Intervention/treatment Phase
Cognitive Change Musculoskeletal Pain Other: Osteopathic Manipulative Treatment Other: Control- No Intervention Not Applicable

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)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

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.




Primary Outcome Measures :
  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, TNF alpha, IL6



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058431


Contacts
Layout table for location contacts
Contact: mireille rizkalla, phd mrizka@midwestern.edu
Contact: ann impens, phd aimpen@midwestern.edu

Locations
Layout table for location information
United States, Illinois
Midwestern Multispecialty Clinic Recruiting
Downers Grove, Illinois, United States, 60515
Contact: mireille rizkalla, phd         
Sponsors and Collaborators
Midwestern University
Investigators
Layout table for investigator information
Principal Investigator: mireille rizkalla, phd Midwestern University
Study Director: Katrina Ivkovic Midwestern University
Layout table for additonal information
Responsible Party: Mireille Rizkalla, Assistant Professor, Midwestern University
ClinicalTrials.gov Identifier: NCT04058431    
Other Study ID Numbers: MWU2761
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mireille Rizkalla, Midwestern University:
cognitive decline
pain
osteopathic manipulative treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations