Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion

Not Applicable

Completed

• Conditions: Concussion Injury of Cerebrum; Cranial Osteopathic Medicine
• Interventions: Other: Cranial Osteopathic Manipulative Medicine

• Registration Number: NCT03225599
• Lead Sponsor: Northwell Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-09
• Primary Completion: 2010-06-30
• Study Completion: 2013-01-26
• Study First Submitted: 2017-07-14
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Results First Submitted: 2017-09-01
• Results First Submitted QC: 2019-03-04
• Status Verified: 2019-06
• Results First Posted: 2019-06-06
• Last Update Submitted: 2019-06-17
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Procedure	Cranial Osteopathic Manipulative Medicine	-

Primary Outcome Measures

Name	Time	Method
Change in Concussive Symptoms on the Post Concussion Symptom Scale	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.