Trial Outcomes & Findings for Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion (NCT NCT03225599)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

2 months

Results posted on

2019-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Procedure n=9 Participants 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.
Age, Customized	27.5 years STANDARD_DEVIATION 16.4 • n=9 Participants
Sex: Female, Male Female	5 Participants n=9 Participants
Sex: Female, Male Male	4 Participants n=9 Participants
Region of Enrollment United States	9 Participants n=9 Participants
Number of Participants that Underwent Procedure	9 participants n=9 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Procedure n=9 Participants 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.
Change in Concussive Symptoms on the Post Concussion Symptom Scale	9 units on a scale Standard Deviation 7

Adverse Events

Procedure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Administrative Director, Clinical Research

Northwell Health

Phone: (516) 881-7064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place