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| Name | Class |
|---|---|
| University of Pittsburgh Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procedure | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cranial Osteopathic Manipulative Medicine | Other | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
2months
There were no direct adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Administrative Director, Clinical Research | Northwell Health | (516) 881-7064 | dcannone1@northwell.edu |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Number of Participants that Underwent Procedure | Number | participants |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |