Osteopathic Manipulation Makes a Neuropsychological Difference

Musculoskeletal Pain Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04058431
• Other study ID #: MWU2761
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: Midwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Change
• Musculoskeletal Pain

Intervention

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
• Control- No Intervention
This group will refrain from getting OMT while in the study.

Locations

Country	Name	City	State
United States	Midwestern Multispecialty Clinic	Downers Grove	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Midwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neuropsychology change	standardized assessment battery	baseline, week 8, week 12
Primary	pain scale change	1-10	baseline, week 8, week 12
Primary	inflammatory markers change	cortisol	baseline, week 8, week 12
Primary	inflammatory marker	TNF Alpha	baseline, week 8, week 12
Primary	Inflammatory marker	IL 6	baseline, week 8, week 12