Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion

Study Overview
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Brief Summary
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Patients who have concussions exhibit an array of symptoms, also known as post-concussive symptoms, including headaches, feeling slowed down or foggy and difficulty with concentration. This study aims to determine if cranial osteopathy can provide additional or expedited symptom relief when accompanying current conventional treatments. The patients will be identified through routine clinical contact. If patients are found to be eligible and agree to participate, they receive a single session of cranial osteopathy in addition to their usual care through the concussion program.

Official Title
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Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion

Conditions
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Concussion Injury of Cerebrum, Cranial Osteopathic Medicine

Intervention / Treatment
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* Other: Cranial Osteopathic Manipulative Medicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Concussion occurred within 8 weeks Age greater or equal to 14 years Complains of post-concussive symptoms with a symptom score of >10 on PCSS Exclusion Criteria: Concussion occurred > 8 weeks Age less than 14 years Surgery of the cervical and/or thoracic spine within the last 3 months Currently receiving or has received workers compensation within the last 3 months Currently or potentially become involved in litigation related to the injury Received osteopathic craniosacral treatments within the last 3 months History of hydrocephalus, current infection or active tumor Active or marked depression, anxiety or psychosis

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Procedure<br> | Other: Cranial Osteopathic Manipulative Medicine<br>* The hands will be placed on the head using the vault hold (bilateral thumbs are off the head, index fingers on the temporal bones, middle fingers on the sphenoid bones, ring fingers on the mastoid and the 5th fingers on the occipital bone). Diagnosis and treatment of restrictions palpated on the scalp will be made using this hand position<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Concussive Symptoms on the Post Concussion Symptom Scale | The Post Concussion Symptom Scale (PCSS) is a scale used to subjectively measure concussion symptoms. The minimum score is 0 and the maximum score is 132 (a maximum score of 6 for 22 items). The higher the value the worse the symptom. Twenty-two possible symptoms are graded and are the following:Headache, Nausea, Vomiting, Balance Problems, Dizziness, Lightheadedness, Fatigue, Trouble falling asleep, Sleeping more than usual, Sleeping less than usual, Drowsiness, Sensitivity to light, Sensitivity to noise, Irritability, Sadness, Nervous/Anxious, Feeling more emotional, Numbness or tingling, Feeling slowed down, Feeling like in a fog, Difficulty concentrating, Difficulty remembering, and/or Visual problems. Total score can range from 0 to 132. Units of a scale is used. | 2 months |