The Role of Osteopathic Manipulative Medicine in Recovery From Concussions

Study Overview
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Brief Summary
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This project aims to study whether adding osteopathic manipulative treatment (OMT) to usual care of concussed patients will enhance their recovery.

Official Title
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The Role of Osteopathic Manipulative Medicine in Recovery From Concussions

Conditions
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Concussion, Brain

Intervention / Treatment
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* Procedure: Osteopathic manipulative treatment
* Procedure: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For this study, participants will be randomly assigned to 1. Usual care, or 2. Usual care and OMT.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care Group<br>Participants in this group will receive routine care for the management and treatment of concussions | Procedure: Usual care<br>* Routine concussion management with healthcare professionals.<br>|
| Experimental: OMT Group<br>Participants who are randomized into the OMT group will receive OMT in addition to their usual care. | Procedure: Osteopathic manipulative treatment<br>* 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.<br>Procedure: Usual care<br>* Routine concussion management with healthcare professionals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | through study completion, up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | through study completion, up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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concussion, Sport-related, Osteopathic manipulative treatment