Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion

NCT03225599 | Completed Results

• 1 other identifier: Concussion COMM
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Concussion Injury of Cerebrum; Cranial Osteopathic Medicine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Procedure

EXPERIMENTAL

Other: Cranial Osteopathic Manipulative Medicine

Interventions

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

Procedure

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• University of Pittsburgh Medical Center: collaborator

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Results Point of Contact

• Title: Administrative Director, Clinical Research
• Organization: Northwell Health

dcannone1@northwell.edu

(516) 881-7064

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 21, 2017
• Study Start: February 9, 2010
• Primary Completion: June 30, 2010
• Study Completion: January 26, 2013
• Last Updated: June 25, 2019
• Results First Posted: June 6, 2019

Record last verified: 2019-06