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Osteopathic Manipulation Makes a Neuropsychological Difference (BOD)

Primary Purpose

Cognitive Change, Musculoskeletal Pain

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment
Control- No Intervention
Sponsored by
Midwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Change focused on measuring cognitive decline, pain, osteopathic manipulative treatment

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Midwestern Multispecialty Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Osteopathic group

Arm Description

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.

Outcomes

Primary Outcome Measures

neuropsychology change
standardized assessment battery
pain scale change
1-10
inflammatory markers change
cortisol
inflammatory marker
TNF Alpha
Inflammatory marker
IL 6

Secondary Outcome Measures

Full Information

First Posted
April 6, 2017
Last Updated
March 14, 2023
Sponsor
Midwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04058431
Brief Title
Osteopathic Manipulation Makes a Neuropsychological Difference
Acronym
BOD
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Midwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Change, Musculoskeletal Pain
Keywords
cognitive decline, pain, osteopathic manipulative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Treatment
Intervention Description
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
Intervention Name(s)
Control- No Intervention
Intervention Description
This group will refrain from getting OMT while in the study.
Primary Outcome Measure Information:
Title
neuropsychology change
Description
standardized assessment battery
Time Frame
baseline, week 8, week 12
Title
pain scale change
Description
1-10
Time Frame
baseline, week 8, week 12
Title
inflammatory markers change
Description
cortisol
Time Frame
baseline, week 8, week 12
Title
inflammatory marker
Description
TNF Alpha
Time Frame
baseline, week 8, week 12
Title
Inflammatory marker
Description
IL 6
Time Frame
baseline, week 8, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mireille rizkalla, phd
Organizational Affiliation
Midwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katrina Ivkovic
Organizational Affiliation
Midwestern University
Official's Role
Study Director
Facility Information:
Facility Name
Midwestern Multispecialty Clinic
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Osteopathic Manipulation Makes a Neuropsychological Difference

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