Clinical trial NCT04058431: Osteopathic Manipulation Makes a Neuropsychological Difference
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cognitive Change
Musculoskeletal Pain
Keywords: cognitive decline
pain
osteopathic manipulative treatment
Lead sponsor: Midwestern University
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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)

Eligibility 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.

Primary outcomes:
measure: neuropsychology change
timeFrame: baseline, week 8, week 12
measure: pain scale change
timeFrame: baseline, week 8, week 12
measure: inflammatory markers change
timeFrame: baseline, week 8, week 12
measure: inflammatory marker
timeFrame: baseline, week 8, week 12
measure: Inflammatory marker
timeFrame: baseline, week 8, week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Downers Grove
country: United States
facility: Midwestern Multispecialty Clinic
state: Illinois
Study officials:
affiliation: Midwestern University
name: mireille rizkalla, phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Midwestern University
name: Katrina Ivkovic
role: STUDY_DIRECTOR
References: