Concussion Injury of Cerebrum, Cranial Osteopathic Medicine
Conditions
Brief summary
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.
Interventions
OTHERCranial Osteopathic Manipulative Medicine
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
Sponsors
University of Pittsburgh Medical Center
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Concussive Symptoms on the Post Concussion Symptom Scale | 2 months | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Procedure The treatment was performed with the patient lying comfortably in a supine position. The examiner's hand was initially placed at the occipito-atlantal junction of the top of the cervical spine to evaluate for fascial restrictions. Any palpated restrictions were released using a technique of myofascial release, where no passive or active range of motion was performed to the cervical region. Once the occipito-atlantal junction was determined to be free of restrictions, fingers were placed on the head using the Vault Hold (Figures 1 & 2). The Vault Hold was used for the administration of the procedure as is standard in osteopathic manipulative medicine by bilateral finger placement: 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. Each procedure lasted less than 30 minutes. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Procedure | — |
|---|---|---|
| Age, Customized | 27.5 years STANDARD_DEVIATION 16.4 | — |
| Number of Participants that Underwent Procedure | 9 participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 9 Participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
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.
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Procedure | Change in Concussive Symptoms on the Post Concussion Symptom Scale | 9 units on a scale | Standard Deviation 7 |