Back to resultsThe Role of Osteopathic Manipulative Medicine in Recovery From Concussions
Primary Purpose
Concussion, Brain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic manipulative treatment
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Concussion, Brain focused on measuring concussion, Sport-related, Osteopathic manipulative treatment
Eligibility Criteria
Inclusion Criteria:
- Age between 14-25 years
- Primary diagnosis of sports-related concussion
- Concussion sustained within the last 10 days
- Participating in a sport at either collegiate or high school level, or other organized sports (e.g. club sports)
Exclusion Criteria:
- Contraindications to OMT, such as skull fracture, cervical fracture, signs of intracranial bleeding, or stroke
- Diagnosis of vertigo or motion sickness
- Diagnosis of migraine headaches
- Surgery within the last 6 months
- Any conditions recognized by a physician as contraindicating or impeding protocol implementation
- Will not be under a care of sports medicine physician
Sites / Locations
- MSU Center for Orthopedic ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual Care Group
OMT Group
Arm Description
Participants in this group will receive routine care for the management and treatment of concussions
Participants who are randomized into the OMT group will receive OMT in addition to their usual care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Return to play duration
Number of days between injury date and receiving clearance to return to play or referred out to other specialists
Full Information
NCT ID
NCT04932278
First Posted
June 11, 2021
Last Updated
June 13, 2023
Sponsor
Michigan State University
Collaborators
American Osteopathic Association
1. Study Identification
Unique Protocol Identification Number
NCT04932278
Brief Title
The Role of Osteopathic Manipulative Medicine in Recovery From Concussions
Official Title
The Role of Osteopathic Manipulative Medicine in Recovery From Concussions
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
American Osteopathic Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This project aims to study whether adding osteopathic manipulative treatment (OMT) to usual care of concussed patients will enhance their recovery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain
Keywords
concussion, Sport-related, Osteopathic manipulative treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
For this study, participants will be randomly assigned to 1. Usual care, or 2. Usual care and OMT.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care Group
Arm Type
Active Comparator
Arm Description
Participants in this group will receive routine care for the management and treatment of concussions
Arm Title
OMT Group
Arm Type
Experimental
Arm Description
Participants who are randomized into the OMT group will receive OMT in addition to their usual care.
Intervention Type
Procedure
Intervention Name(s)
Osteopathic manipulative treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
Routine concussion management with healthcare professionals.
Primary Outcome Measure Information:
Title
SCAT5 symptom evaluation score
Description
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.
Time Frame
through study completion, up to 4 weeks
Secondary Outcome Measure Information:
Title
Head position tracking accuracy
Description
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.
Time Frame
2 weeks from injury
Title
Head force tracking accuracy
Description
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.
Time Frame
2 weeks from injury
Title
Return to play duration
Description
Number of days between injury date and receiving clearance to return to play or referred out to other specialists
Time Frame
through study completion, up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacek Cholewicki, PhD
Phone
517-353-4800
Email
cholewic@msu.edu
Facility Information:
Facility Name
MSU Center for Orthopedic Research
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacek Cholewicki, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Role of Osteopathic Manipulative Medicine in Recovery From Concussions
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