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.

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Key information

Conditions

Concussion Injury of Cerebrum Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cranial Osteopathic Medicine Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cranial Osteopathic Manipulative Medicine

Other

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

Primary outcomes

Change in Concussive Symptoms on the Post Concussion Symptom Scale

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

University of Pittsburgh Medical Center

Registry information

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2013
First posted: Jul 21, 2017
Registry last updated: Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed