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Clinical Trials/NCT03225599
NCT03225599
Completed
Not Applicable

Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion

Northwell Health0 sites9 target enrollmentFebruary 9, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Concussion Injury of Cerebrum
Sponsor
Northwell Health
Enrollment
9
Primary Endpoint
Change in Concussive Symptoms on the Post Concussion Symptom Scale
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 9, 2010
End Date
January 26, 2013
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rosanna C. Sabini, DO

Assistant Professor

Northwell Health

Eligibility Criteria

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

Outcomes

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.

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