Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy

NCT ID: NCT04063618

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-03
• Study Completion Date: 2021-11-16

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.

Conditions

Concussion, Brain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Osteopathic Manipulative Therapy (OMT) Treatment Group

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.

Group Type: EXPERIMENTAL

Osteopathic Manipulative Therapy

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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).

Standard of care concussion treatment group

Standard of care concussion treatment without OMT

Group Type: ACTIVE_COMPARATOR

Standard of Care Concussion Treatment

Intervention Type: PROCEDURE

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).

Interventions

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.

Intervention Type: PROCEDURE

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).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Matthew T. Mcelroy, DO

OTHER

Sponsor Role: lead

Responsible Party

Matthew T. Mcelroy, DO

Staff Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Matthew McElroy, DO

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Woodbine

Danville, Pennsylvania, United States

Countries

United States

Other Identifiers

2019-0612

Identifier Type: -

Identifier Source: org_study_id