Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion

NCT ID: NCT03225599

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-09
• Study Completion Date: 2013-01-26

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Procedure

Group Type: EXPERIMENTAL

Cranial Osteopathic Manipulative Medicine

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh Medical Center

OTHER

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Rosanna C. Sabini, DO

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Concussion COMM

Identifier Type: -

Identifier Source: org_study_id