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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
Must not have
Contraindications to OMT, such as skull fracture, cervical fracture, signs of intracranial bleeding, or stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 4 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I don't have a skull or neck fracture, bleeding in the brain, or a recent stroke.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
198 Previous Clinical Trials
685,658 Total Patients Enrolled
American Osteopathic AssociationOTHER
20 Previous Clinical Trials
3,579 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
~18 spots leftby Dec 2025
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