The Role of Osteopathic Manipulative Medicine in Recovery From Concussions

April 13, 2026 updated by: Jacek Cholewicki, Michigan State University
This project aims to study whether adding osteopathic manipulative treatment (OMT) to usual care of concussed patients will enhance their recovery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • MSU Center for Orthopedic Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 13-55 years
  • Concussion sustained within the last 12 days

Exclusion Criteria:

  • Contraindications to OMT, such as skull fracture, cervical fracture, signs of intracranial bleeding, or stroke
  • Neck surgery within the last 6 months
  • Any conditions recognized by a physician as contraindicating or impeding protocol implementation
  • Will not be under the care of a healthcare professional
  • Any active (or pending) worker's compensation, disability, or personal injury claims related to their concussion injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care Group
Participants in this group will receive routine care for the management and treatment of concussions
Procedure: Usual care
Routine concussion management with healthcare professionals.
Experimental: OMT Group
Participants who are randomized into the OMT group will receive OMT in addition to their usual care.
Procedure: Osteopathic manipulative treatment
Osteopathic manipulative treatment (OMT) is hands-on care provided by an osteopathic physician (D.O.). During osteopathic manipulative treatment, an osteopathic physician may move participants' muscles and joints using osteopathic techniques including stretching, gentle pressure and resistance, as well as thrust techniques that apply a quick, therapeutic force of brief duration that travels a short distance.
Procedure: Usual care
Routine concussion management with healthcare professionals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCAT5 symptom evaluation score
Time Frame: through study completion, up to 4 weeks
Symptom evaluation score is a self-reported measure of the participants' post-concussion symptoms. Participants are scored on Total Number of Symptoms (ranges 0 to 22) and Symptom Severity Score (ranges 0 to 132). Higher scores represent worse outcome.
through study completion, up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Head position tracking accuracy
Time Frame: 2 weeks from injury
Participants will be seated in an upright position with their upper body secured to a backrest and will wear a head harness with an attached position sensor. The angular position of the head will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by moving their head. Accuracy will be determined by taking the difference between the target position signal and the actual head position.
2 weeks from injury
Head force tracking accuracy
Time Frame: 2 weeks from injury
Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. The pad will be attached to a load cell that monitors how much force is being generated by their head. The force level will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by generating force with their head. Accuracy will be determined by taking the difference between target force signal and the actual head force.
2 weeks from injury
Return to play duration
Time Frame: through study completion, up to 4 weeks
Number of days between injury date and receiving clearance to return to play or referred out to other specialists
through study completion, up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan State University

Collaborators

American Osteopathic Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2021

Primary Completion (Actual)

July 9, 2025

Study Completion (Actual)

July 10, 2025

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY4542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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