NCT04058431

Osteopathic Manipulation Makes a Neuropsychological Difference

Examining Osteopathic Manipulation on Making a Neuropsychological Brain of Difference in Adults With Pain: A BOD Study Protocol and Rationale for a New Approach

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Midwestern University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2019-08-15
• Last updated: 2025-09-30

Locations

1 site across 1 country: United States