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Osteopathic Manipulation for Cognitive Impairment (BOD Trial)
N/A
Waitlist Available
Led By mireille rizkalla, phd
Research Sponsored by Midwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 8, week 12
Awards & highlights
No Placebo-Only Group
Summary
This trial found that osteopathic manipulative treatment (OMT) can help improve cognitive function in patients with pain.
Who is the study for?
This trial is for individuals over 40 seeking treatment for acute or chronic musculoskeletal pain (like neck, shoulder, or back pain) who feel it's affecting their thinking. They must not have had any recent surgery, manipulation treatments like massage or chiropractic work in the past six months, and should not be on certain medications.
What is being tested?
The study is testing if Osteopathic Manipulative Treatment (OMT), a hands-on therapy often used to treat pain, can also improve cognitive functions such as memory and attention in patients with musculoskeletal pain.
What are the potential side effects?
While the trial description does not specify side effects of OMT, common ones may include soreness similar to after exercise and less commonly headaches or fatigue post-treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 8, week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 8, week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Inflammatory marker
inflammatory marker
inflammatory markers change
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Osteopathic groupExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
Midwestern UniversityLead Sponsor
20 Previous Clinical Trials
3,542 Total Patients Enrolled
Katrina IvkovicStudy DirectorMidwestern University
mireille rizkalla, phdPrincipal InvestigatorMidwestern University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot take the prescribed medication.You are taking medication that could affect the measurement of certain substances in your body.You changed your mental health medication within the last 2 months.You scored higher than 23 on a test to check how well you can remember things and think clearly over the phone.You answered "yes" when asked if your pain has caused you to have trouble thinking.You have had surgery or other medical procedures in the last six months.You have been diagnosed with brain-related memory or thinking issues.You are 40 years old or older.You are looking for treatment for neck, shoulder, or back pain.
Research Study Groups:
This trial has the following groups:- Group 1: Osteopathic group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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