Cognitive ChangeBODNCT04058431
Osteopathic Manipulation Makes a Neuropsychological Difference
A study testing Osteopathic Manipulative Treatment in people with Cognitive Change and Musculoskeletal Pain, run by Midwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cognitive Change, Musculoskeletal Pain
- What is being tested?
- Osteopathic Manipulative Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwestern Multispecialty Clinic
Downers Grove, Illinois, 60515
About this study
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
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.
Read the 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:
- 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)
- Conditions
- Cognitive Change, Musculoskeletal Pain
- Being tested
- Osteopathic Manipulative Treatment, Control- No Intervention
- Keywords
- cognitive decline, pain, osteopathic manipulative treatment
- Medical subject headings
- Musculoskeletal Pain, Cognitive Dysfunction, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentOther
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 InterventionOther
This group will refrain from getting OMT while in the study.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic group | Experimental | 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. Receives: Other: Osteopathic Manipulative Treatment; Other: Control- No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuropsychology change
standardized assessment battery
Measured: baseline, week 8, week 12
pain scale change
1-10
Measured: baseline, week 8, week 12
inflammatory markers change
cortisol
Measured: baseline, week 8, week 12
inflammatory marker
TNF Alpha
Measured: baseline, week 8, week 12
Inflammatory marker
IL 6
Measured: baseline, week 8, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study startJan 2017
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Midwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mireille Rizkalla, Midwestern University
- Investigators
- mireille rizkalla, phd, Principal investigator, Midwestern UniversityKatrina Ivkovic, Study director, Midwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058431
- Sponsor's protocol ID
- MWU2761
- Acronym
- BOD
- Status last verified
- Sep 2025
- First submitted
- 6 Apr 2017
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04058431
- Acronym / sponsor ID
- BOD / MWU2761
- Conditions
- Cognitive Change, Musculoskeletal Pain
- Keywords
- cognitive decline, pain, osteopathic manipulative treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Midwestern UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteopathic group | Experimental | Other: Osteopathic Manipulative Treatment, Other: Control- No InterventionTreatment 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TreatmentOsteopathic 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 | Osteopathic group |
| Control- No InterventionThis group will refrain from getting OMT while in the study. | Other | Osteopathic group |
Primary outcome
neuropsychology change
Time frame: baseline, week 8, week 12
standardized assessment battery
pain scale change
Time frame: baseline, week 8, week 12
1-10
inflammatory markers change
Time frame: baseline, week 8, week 12
cortisol
inflammatory marker
Time frame: baseline, week 8, week 12
TNF Alpha
Inflammatory marker
Time frame: baseline, week 8, week 12
IL 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mireille rizkalla, phd principal investigator
Midwestern University
Katrina Ivkovic study director
Midwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment in people with Cognitive Change and Musculoskeletal Pain, run by Midwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuropsychology change (time frame: baseline, week 8, week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.