Osteopathic Manipulation Makes a Neuropsychological Difference

Not Applicable

Active, not recruiting

• Conditions: Cognitive Change; Musculoskeletal Pain
• Interventions: Other: Osteopathic Manipulative Treatment; Other: Control- No Intervention

• Registration Number: NCT04058431
• Lead Sponsor: Midwestern University

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)

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Osteopathic group	Osteopathic Manipulative Treatment	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.
Osteopathic group	Control- No Intervention	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.

Primary Outcome Measures

Name	Time	Method
neuropsychology change	baseline, week 8, week 12	standardized assessment battery
pain scale change	baseline, week 8, week 12	1-10
inflammatory markers change	baseline, week 8, week 12	cortisol
inflammatory marker	baseline, week 8, week 12	TNF Alpha
Inflammatory marker	baseline, week 8, week 12	IL 6

Trial Locations

Locations (1)

Midwestern Multispecialty Clinic; 🇺🇸 Downers Grove, Illinois, United States