The Role of Osteopathic Manipulative Medicine in Recovery From Concussions

Concussion, Brain Clinical Trial

Official title:

The Role of Osteopathic Manipulative Medicine in Recovery From Concussions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04932278
• Other study ID #: STUDY4542
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain

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