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Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy

Primary Purpose

Concussion, Brain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Therapy
Standard of Care Concussion Treatment
Sponsored by
Matthew T. Mcelroy, DO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concussion, Brain

Eligibility Criteria

undefined - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients referred to the Geisinger sports medicine clinic or athletic training room for concussion evaluation and management
  2. Age less than 25 years old
  3. Enrolled in high school or college
  4. Participating in a sport at either collegiate or high school level

Exclusion Criteria:

  1. Diagnosis does not meet criteria for concussion
  2. Symptoms of concussion not present on initial visit
  3. Patient unable to tolerate the OMT treatment
  4. Patient needs intervention beyond standard concussion management
  5. Patients not able to provide consent to be a part of the study

Sites / Locations

  • Geisinger Woodbine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Osteopathic Manipulative Therapy (OMT) Treatment Group

Standard of care concussion treatment group

Arm Description

Initial concussion treatment will involve OMT in addition to standard of care treatment. The OMT practitioner, using a strong anatomic knowledge base, applies specific genital forces in the dysfunctional area, thus providing aid to the body's innate mechanisms of healing. During OMT, a patient's muscles and joints are moved using techniques that include stretching, gentle pressure, and resistance.

Standard of care concussion treatment without OMT

Outcomes

Primary Outcome Measures

Concussion Severity Score
Patient will score him or herself on a scale from 0-6 for each of 22 concussion related symptoms. A score of "0" is equal to no symptoms, a score of 1-2 is mild, a score of 3-4 is moderate, a score of 5-6 is severe. Total score is calculated by adding each individual item score. Higher scores are worse than lower scores.
Duration of concussion symptoms
Measured in days; how does Concussion Severity Score change over time
Time to start of the return to play protocol
Measured in days; Once diagnosed, return to play is dependent on recovery from symptoms followed by a specific protocol for clearance; the sooner the symptoms subside the sooner the protocol is initiated.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2019
Last Updated
March 29, 2023
Sponsor
Matthew T. Mcelroy, DO
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1. Study Identification

Unique Protocol Identification Number
NCT04063618
Brief Title
Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy
Official Title
Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy: A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Insufficient subject enrollment
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
November 16, 2021 (Actual)
Study Completion Date
November 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matthew T. Mcelroy, DO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Concussion incidence in high school and collegiate sports is high, especially in football. Once diagnosed, return to play is dependent on recovery from symptoms followed by a specific protocol for clearance; the sooner the symptoms subside the sooner the protocol is initiated. Osteopathic Manipulative Therapy (OMT) is a low risk procedure that has minimal side effects and has been used to decrease both headache intensity and frequency. With the main subjective symptom tracked for concussion being headache, OMT may be used to decrease the severity and the duration of this symptom.
Detailed Description
Concussion incidence in high school and collegiate sports is high, especially in football. These injuries have become the focus of the sports world, as coaches, trainers, and medical personnel are more vigilant than ever in screening for concussions. Once diagnosed, return to play is dependent on recovery from symptoms followed by a specific protocol for clearance; the sooner the symptoms subside the sooner the protocol is initiated. Osteopathic Manipulative Therapy (OMT) is a low risk procedure that has minimal side effects and has been used to decrease both headache intensity and frequency. With the main subjective symptom tracked for concussion being headache, OMT can be used to decrease the severity and the duration of this symptom. In a prospective superiority comparison between standard of care for concussion (rest and return to play protocol) and a single OMT treatment in combination with standard therapy, we hypothesize that OMT decreases symptom duration and severity of headache in concussion management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic Manipulative Therapy (OMT) Treatment Group
Arm Type
Experimental
Arm Description
Initial concussion treatment will involve OMT in addition to standard of care treatment. The OMT practitioner, using a strong anatomic knowledge base, applies specific genital forces in the dysfunctional area, thus providing aid to the body's innate mechanisms of healing. During OMT, a patient's muscles and joints are moved using techniques that include stretching, gentle pressure, and resistance.
Arm Title
Standard of care concussion treatment group
Arm Type
Active Comparator
Arm Description
Standard of care concussion treatment without OMT
Intervention Type
Procedure
Intervention Name(s)
Osteopathic Manipulative Therapy
Intervention Description
The OMT practitioner, using a strong anatomic knowledge base, applies specific genital forces in the dysfunctional area, thus providing aid to the body's innate mechanisms of healing. During OMT, a patient's muscles, joints, and tissues are moved using techniques that include stretching, gentle pressure, and resistance.
Intervention Type
Procedure
Intervention Name(s)
Standard of Care Concussion Treatment
Intervention Description
Standard of care for concussion management is cognitive rest, meaning no stimulation (or as little as possible). This mean no TV/phones/music/school/homework generally for 24 hours. After that a return to academic work is typically started. Once patient is symptom free for 24 hours, then the return to play protocol is initiated (this takes 7 total days to complete at a minimum).
Primary Outcome Measure Information:
Title
Concussion Severity Score
Description
Patient will score him or herself on a scale from 0-6 for each of 22 concussion related symptoms. A score of "0" is equal to no symptoms, a score of 1-2 is mild, a score of 3-4 is moderate, a score of 5-6 is severe. Total score is calculated by adding each individual item score. Higher scores are worse than lower scores.
Time Frame
7 days
Title
Duration of concussion symptoms
Description
Measured in days; how does Concussion Severity Score change over time
Time Frame
7 days
Title
Time to start of the return to play protocol
Description
Measured in days; Once diagnosed, return to play is dependent on recovery from symptoms followed by a specific protocol for clearance; the sooner the symptoms subside the sooner the protocol is initiated.
Time Frame
7 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients referred to the Geisinger sports medicine clinic or athletic training room for concussion evaluation and management Age less than 25 years old Enrolled in high school or college Participating in a sport at either collegiate or high school level Exclusion Criteria: Diagnosis does not meet criteria for concussion Symptoms of concussion not present on initial visit Patient unable to tolerate the OMT treatment Patient needs intervention beyond standard concussion management Patients not able to provide consent to be a part of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew McElroy, DO
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Woodbine
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17821
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy

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