Concussion, Brain
Conditions
Keywords
concussion, Sport-related, Osteopathic manipulative treatment
Brief summary
This project aims to study whether adding osteopathic manipulative treatment (OMT) to usual care of concussed patients will enhance their recovery.
Interventions
PROCEDUREOsteopathic 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.
PROCEDUREUsual care
Routine concussion management with healthcare professionals.
Sponsors
Michigan State University
American Osteopathic Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
For this study, participants will be randomly assigned to 1. Usual care, or 2. Usual care and OMT.
Eligibility
Sex/Gender
ALL
Age
13 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCAT5 symptom evaluation score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Head position tracking accuracy | 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. |
| Head force tracking accuracy | 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. |
| Return to play duration | 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 |
Countries
United States
Outcome results
None listed