Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy

Concussion, Brain Clinical Trial

Official title:

Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy: A Prospective Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04063618
• Other study ID #: 2019-0612
• Status: Terminated
• Phase: N/A
• Start date: December 3, 2019
• Est. completion date: November 16, 2021

Study information

• Verified date: March 2023
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 16, 2021
• Est. primary completion date: November 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain

Intervention

Procedure:
• Osteopathic Manipulative Therapy
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.
• Standard of Care Concussion Treatment
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).

Locations

Country	Name	City	State
United States	Geisinger Woodbine	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Matthew T. Mcelroy, DO

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days
Primary	Duration of concussion symptoms	Measured in days; how does Concussion Severity Score change over time	7 days
Primary	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.	7 days