Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion

Concussion Injury of Cerebrum Clinical Trial

Official title:

Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225599
• Other study ID #: Concussion COMM
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Concussion Injury of Cerebrum
• Cranial Osteopathic Medicine

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