The Role of Osteopathic Manipulative Medicine in Recovery From Concussions

Not Applicable

Recruiting

• Conditions: Concussion, Brain
• Interventions: Procedure: Osteopathic manipulative treatment; Procedure: Usual care

• Registration Number: NCT04932278
• Lead Sponsor: Michigan State University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-21
• Study Start: 2021-09-22
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMT Group	Osteopathic manipulative treatment	Participants who are randomized into the OMT group will receive OMT in addition to their usual care.
Usual Care Group	Usual care	Participants in this group will receive routine care for the management and treatment of concussions
OMT Group	Usual care	Participants who are randomized into the OMT group will receive OMT in addition to their usual care.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MSU Center for Orthopedic Research; 🇺🇸 East Lansing, Michigan, United States