Concussion, BrainNCT04932278
The Role of Osteopathic Manipulative Medicine in Recovery From Concussions
A study testing Osteopathic manipulative treatment in people with Concussion, Brain, run by Michigan State University at 1 site in United States.
Trial summary
This project aims to study whether adding osteopathic manipulative treatment (OMT) to usual care of concussed patients will enhance their recovery. Read more about this study
- Who is it for?
- Ages 13 to 55 years
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- Osteopathic manipulative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2021to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 13-55 years
- Concussion sustained within the last 12 days
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
MSU Center for Orthopedic Research
East Lansing, Michigan, 48824
About this study
This project aims to study whether adding osteopathic manipulative treatment (OMT) to usual care of concussed patients will enhance their recovery.
- Conditions
- Concussion, Brain
- Being tested
- Osteopathic manipulative treatment, Usual care
- Keywords
- concussion, Sport-related, Osteopathic manipulative treatment
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulative treatmentProcedure or surgery
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.
Usual careProcedure or surgery
Routine concussion management with healthcare professionals.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | Active comparator | Participants in this group will receive routine care for the management and treatment of concussions Receives: Procedure: Usual care |
| OMT Group | Experimental | Participants who are randomized into the OMT group will receive OMT in addition to their usual care. Receives: Procedure: Osteopathic manipulative treatment; Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCAT5 symptom evaluation score
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.
Measured: through study completion, up to 4 weeks
Secondary outcomes (3)
Head position tracking accuracy
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.
Measured: 2 weeks from injury
Head force tracking accuracy
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.
Measured: 2 weeks from injury
Return to play duration
Number of days between injury date and receiving clearance to return to play or referred out to other specialists
Measured: through study completion, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start22 Sep 2021
- Primary completion9 Jul 2025
- Study completion10 Jul 2025
Why it stopped: Due to lower than anticipated enrollment number, this study was stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- For this study, participants will be randomly assigned to 1. Usual care, or 2. Usual care and OMT.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Association
- Responsible party
- Principal investigator, Jacek Cholewicki, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932278
- Sponsor's protocol ID
- STUDY4542
- Status last verified
- Jul 2025
- First submitted
- 11 Jun 2021
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Osteopathic Manipulative Medicine in Recovery From Concussions
- ClinicalTrials.gov ID
- NCT04932278
- Acronym / sponsor ID
- STUDY4542
- Conditions
- Concussion, Brain
- Keywords
- concussion, Sport-related, Osteopathic manipulative treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lower than anticipated enrollment number, this study was stopped.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- American Osteopathic Association
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 21 Jun 2021 (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.
This project aims to study whether adding osteopathic manipulative treatment (OMT) to usual care of concussed patients will enhance their recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- For this study, participants will be randomly assigned to 1. Usual care, or 2. Usual care and OMT.
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | Active comparator | Procedure: Usual careParticipants in this group will receive routine care for the management and treatment of concussions |
| OMT Group | Experimental | Procedure: Osteopathic manipulative treatment, Procedure: Usual careParticipants who are randomized into the OMT group will receive OMT in addition to their usual care. |
Who may qualify
- Ages
- 13 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age between 13-55 years
- Concussion sustained within the last 12 days
Key exclusion criteria (5 listed)
- 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
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 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 or surgery | OMT Group |
| Usual careRoutine concussion management with healthcare professionals. | Procedure or surgery | OMT Group, Usual Care Group |
Primary outcome
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.
3 secondary outcomes
Head position tracking accuracy
Time frame: 2 weeks from injury
Head force tracking accuracy
Time frame: 2 weeks from injury
Return to play duration
Time frame: through study completion, up to 4 weeks
Results and safety
The study was stopped early (reason given: Due to lower than anticipated enrollment number, this study was stopped.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Concussion, Brain, run by Michigan State 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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Apr 2026. 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?
The study was stopped early (reason given: Due to lower than anticipated enrollment number, this study was stopped.). Results are not available in the source record.
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?
SCAT5 symptom evaluation score (time frame: through study completion, up to 4 weeks). 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 16 Apr 2026.