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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04932278
Other study ID # STUDY4542
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 22, 2021
Est. completion date August 2024

Study information

Verified date June 2023
Source Michigan State University
Contact Jacek Cholewicki, PhD
Phone 517-353-4800
Email cholewic@msu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 76
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 13 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Usual care
Routine concussion management with healthcare professionals.

Locations

Country Name City State
United States MSU Center for Orthopedic Research East Lansing Michigan

Sponsors (2)

Lead Sponsor Collaborator
Michigan State University American Osteopathic Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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