Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy

Not Applicable

Terminated

• Conditions: Concussion, Brain
• Interventions: Procedure: Osteopathic Manipulative Therapy; Procedure: Standard of Care Concussion Treatment

• 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

Arm && Interventions

Group	Intervention	Description
Osteopathic Manipulative Therapy (OMT) Treatment Group	Osteopathic Manipulative Therapy	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 group	Standard of Care Concussion Treatment	Standard of care concussion treatment without OMT
Osteopathic Manipulative Therapy (OMT) Treatment Group	Standard of Care Concussion Treatment	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Geisinger Woodbine; 🇺🇸 Danville, Pennsylvania, United States