The Role of Osteopathic Manipulative Medicine in Recovery From Concussions

NCT ID: NCT04932278

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-22

Study Completion Date

2024-08-31

Brief Summary

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

Detailed Description

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Conditions

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Concussion, Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

For this study, participants will be randomly assigned to 1. Usual care, or 2. Usual care and OMT.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care Group

Participants in this group will receive routine care for the management and treatment of concussions

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type PROCEDURE

Routine concussion management with healthcare professionals.

OMT Group

Participants who are randomized into the OMT group will receive OMT in addition to their usual care.

Group Type EXPERIMENTAL

Osteopathic manipulative treatment

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Routine concussion management with healthcare professionals.

Interventions

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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.

Intervention Type PROCEDURE

Usual care

Routine concussion management with healthcare professionals.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Osteopathic Association

OTHER

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Jacek Cholewicki

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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MSU Center for Orthopedic Research

East Lansing, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jacek Cholewicki, PhD

Role: CONTACT

517-353-4800

Facility Contacts

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Jacek Cholewicki, PhD

Role: primary

Other Identifiers

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STUDY4542

Identifier Type: -

Identifier Source: org_study_id

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