Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion

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.

Study Overview

• Status: Completed
• Conditions: Concussion Injury of Cerebrum; Cranial Osteopathic Medicine
• Intervention / Treatment: Other: Cranial Osteopathic Manipulative Medicine

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Procedure	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2010
• Primary Completion (Actual): June 30, 2010
• Study Completion (Actual): January 26, 2013

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Concussion COMM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No