Osteopathic Manipulation Makes a Neuropsychological Difference

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Cognitive Change, Musculoskeletal Pain

Intervention / Treatment
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* Other: Osteopathic Manipulative Treatment
* Other: Control- No Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteopathic group<br>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<br>* 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<br>Other: Control- No Intervention<br>* This group will refrain from getting OMT while in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive decline, pain, osteopathic manipulative treatment