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Osteopathic Manipulative Treatment for Concussion

N/A
Recruiting
Research Sponsored by Michigan State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 13-55 years
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 4 weeks
Awards & highlights

Study Summary

This trial will study if adding OMT to usual care can help people recover from a concussion.

Who is the study for?
This trial is for individuals aged 13-55 who have had a concussion in the last 12 days. It's not suitable for those with conditions like skull fractures, recent neck surgery, or intracranial bleeding that make osteopathic treatment risky, nor for those not under professional care or involved in related legal claims.Check my eligibility
What is being tested?
The study is testing if adding osteopathic manipulative treatment (OMT) to regular care helps people recover from concussions better. Participants will either receive this additional OMT or just continue with their usual healthcare routines.See study design
What are the potential side effects?
Osteopathic manipulative treatment generally has minimal side effects but may include discomfort during manipulation, soreness following treatment, and fatigue. The risk of serious side effects is low when performed by a trained practitioner.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 13 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SCAT5 symptom evaluation score
Secondary outcome measures
Head force tracking accuracy
Head position tracking accuracy
Return to play duration

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OMT GroupExperimental Treatment2 Interventions
Participants who are randomized into the OMT group will receive OMT in addition to their usual care.
Group II: Usual Care GroupActive Control1 Intervention
Participants in this group will receive routine care for the management and treatment of concussions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osteopathic manipulative treatment
2014
Completed Phase 3
~1320
Usual care
2011
Completed Phase 4
~23770

Find a Location

Who is running the clinical trial?

Michigan State UniversityLead Sponsor
185 Previous Clinical Trials
601,951 Total Patients Enrolled
American Osteopathic AssociationOTHER
19 Previous Clinical Trials
3,589 Total Patients Enrolled

Media Library

Osteopathic manipulative treatment Clinical Trial Eligibility Overview. Trial Name: NCT04932278 — N/A
Concussion Clinical Trial 2023: Osteopathic manipulative treatment Highlights & Side Effects. Trial Name: NCT04932278 — N/A
Osteopathic manipulative treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT04932278 — N/A
Concussion Research Study Groups: Usual Care Group, OMT Group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for individuals to join this research endeavor?

"Affirmative. The clinicaltrial.gov page reveals that recruitment for this trial is ongoing, with the original posting on September 22nd 2021 and most recent update taking place June 13th of 2023. There are 76 patients to be recruited at one site."

Answered by AI

Are elderly individuals being recruited for the experiment?

"Adhering to the entry requirements of this trial, potential participants must be between 13 and 55 years old."

Answered by AI

What is the current enrollment rate of participants in this trial?

"Affirmative. Data hosted on clinicaltrials.gov denotes that this research, which was first posted on September 22nd 2021, is actively recruiting. In order to meet the desired sample size of 76 individuals, only one location has been selected for enrollment purposes."

Answered by AI

Are there specific criteria that make an individual qualified to participate in this trial?

"This clinical trial is suitable for patients aged between 13 and 55 that have experienced concussion. As of now, around 76 participants are being accepted to the study."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
< 18
What site did they apply to?
MSU Center for Orthopedic Research
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The Role of Osteopathic Manipulative Medicine in Recovery From Concussions
Jacek Cholewicki 2021. "The Role of Osteopathic Manipulative Medicine in Recovery From Concussions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04932278.
All > Concussion
~4 spots leftby Aug 2024
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