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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03225599
Other study ID # Concussion COMM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 9, 2010
Est. completion date January 26, 2013

Study information

Verified date June 2019
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date January 26, 2013
Est. primary completion date June 30, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years and older
Eligibility 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

Study Design


Intervention

Other:
Cranial 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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Northwell Health University of Pittsburgh Medical Center

Outcome

Type Measure Description Time frame Safety issue
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. 2 months
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