Clinical trial NCT04063618: 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
Overall status: TERMINATED
Phase: NA
Conditions: Concussion, Brain
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 1
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Concussion Severity Score
timeFrame: 7 days
measure: Duration of concussion symptoms
timeFrame: 7 days
measure: Time to start of the return to play protocol
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Woodbine
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Matthew McElroy, DO
role: PRINCIPAL_INVESTIGATOR
References: