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Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04063618
Enrollment
1
Registered
2019-08-21
Start date
2019-12-03
Completion date
2021-11-16
Last updated
2023-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concussion, Brain

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.

Interventions

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.

PROCEDUREStandard 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).

Sponsors

Matthew T. Mcelroy, DO
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 24 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Concussion Severity Score7 daysPatient 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.
Duration of concussion symptoms7 daysMeasured in days; how does Concussion Severity Score change over time
Time to start of the return to play protocol7 daysMeasured 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026