Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy

Not Applicable

Terminated

• Conditions: Concussion, Brain

• Registration Number: NCT04063618
• Lead Sponsor: Matthew T. Mcelroy, DO

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.

Study Timeline

• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-21
• Study Start: 2019-12-03
• Primary Completion: 2021-11-16
• Study Completion: 2021-11-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to start of the return to play protocol	7 days	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.
Duration of concussion symptoms	7 days	Measured in days; how does Concussion Severity Score change over time
Concussion Severity Score	7 days	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.

Trial Locations

Locations (1)

Geisinger Woodbine; 🇺🇸 Danville, Pennsylvania, United States