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Comparing the Effect of Osteopathic Manipulative Medicine (OMM) Versus Counseling in the Treatment of Concussion

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ClinicalTrials.gov Identifier: NCT02750566
Recruitment Status : Recruiting
First Posted : April 25, 2016
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Sheldon Yao, New York Institute of Technology

Brief Summary:
Concussion or mild traumatic brain injury (TBI) is a challenging injury for physicians to manage and is among the most serious disabling neurological disorders. Physician awareness regarding manifestations of TBI and subsequent treatment are paramount to reduce the burden of disease. Advancements in treatment of mild TBI have been slow with a lack of consensus on treatment methods that show universal success. This gap in treatment choices provides an opportunity for osteopathic manipulative treatment (OMT) to fill. OMT is a hands-on manual therapy that can be integrated to help treat post-concussive symptoms. Previous studies have shown that OMT can help resolve imbalance and tinnitus in elderly populations and case studies have shown that this manual therapy may assist in patient recovery. The investigators hypothesize that OMT will decrease return to play/work time, will show an improvement in balance, and will decrease concussion symptoms as compared to counseling.

Condition or disease Intervention/treatment Phase
Post-Concussion Symptoms Distorted; Balance Procedure: Osteopathic Manipulative Treatment Other: Counseling Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Effect of Osteopathic Manipulative Medicine (OMM) Versus Counseling in the Treatment of Concussion
Actual Study Start Date : November 15, 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Osteopathic Manipulative Treatment
A board certified NMM/OMM or FP/OMM physician will perform an osteopathic structural exam and osteopathic treatment for a 30 minute session. The investigators will follow a generalized protocol for diagnosis and treatment of the head, neck, spine, rib cage, and pelvis. The following techniques will be included in the treatment protocol, OA (Occipitoatlantal) decompression, V-Spread, venous sinus drainage, balanced membranous tension (BMT), cranial lifts, CV4, and a mix of balanced ligamentous tension (BLT), muscle energy techniques, facilitated positional release, articulatory techniques (ART), high-velocity low-amplitude, and counterstrain to address any somatic dysfunctions.
Procedure: Osteopathic Manipulative Treatment
Manual treatment of musculoskeletal restrictions that may be prevent proper healing post-concussion.
Other Name: Osteopathic Manipulative Medicine

Active Comparator: Counseling
For the control group, an investigator will complete a 30-minute counseling session with the subject. The focus of discussion will be from the CDC's "What to expect after a concussion" article. Other resources that will also be used come from the American Academy of Family Physicians (AAFP), FamilyDoctor.org, and the Brain Care Center. Each counseling session will follow the same protocol. The counseling session will provide subject with similar face-to-face time with the OMT arm.
Other: Counseling
Patients will be counseled on concussion awareness, symptoms, and treatment for 30 minutes by a physician.




Primary Outcome Measures :
  1. SMART Balance Master balance scores pre and post intervention arm [ Time Frame: change from the pre-intervention score after the intervention, measured at each visit through study completion, an average of 1 week after the initial visit ]
    OMT should show a statistically significant improvement in balance as measured by SMART Balance Master balance scores as measured by change pre and post procedure


Secondary Outcome Measures :
  1. Post-concussion symptoms as measured by ImPACT [ Time Frame: measured on day 1, day 3, and day 7 post concussion ]
    OMT should decrease concussion symptoms as measured by subject responses on this performance test as measured by change pre and post procedure

  2. Post-concussion symptoms as measured by King-Devick [ Time Frame: measured on day 1, day 3, and day 7 post concussion ]
    OMT should decrease concussion symptoms as measured by subject responses on this performance test as measured by change pre and post procedure.

  3. Post-concussion symptoms as measured by SCAT-3 [ Time Frame: measured on day 1, day 3, and day 7 post concussion ]
    OMT should decrease concussion symptoms as measured by subject responses on this survey as measured by change pre and post procedure.


Other Outcome Measures:
  1. Return to play time [ Time Frame: Up to 90 days ]
    Players will be tracked for eventual clearance to return to play and OMT should decrease return to play time.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is at least 18 years age
  • Subject has suffered from non-life threatening head trauma head trauma resulting in current concussion-related symptoms
  • Subject is evaluated and diagnosed with a concussion
  • Subject has been cleared to participate in the study by the physician/neurologist having excluded any potential emergent conditions

Exclusion Criteria:

  • The subject has no absolute contraindications to osteopathic manipulative treatment, such as skull fracture, cervical fracture, signs of intracranial bleeding, cervical dissection, or stroke
  • The subject suffered from any of the following at the time of event leading to concussion:

    • Loss of consciousness >2 minutes in the field
    • Seizures
    • Intractable vomiting
    • Paralysis
  • The subject has been diagnosed with an underlying neurodegenerative condition that may confound test results (e.g.. Parkinson's Disease, Alzheimer's Disease)
  • The subject has a current or previous spinal cord injury
  • The subject is unable to complete the assessment tools
  • The subject is pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750566


Contacts
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Contact: Sheldon C Yao, DO 516-686-3799 syao@nyit.edu
Contact: Adena Leder, DO 516-686-4001 aleder@nyit.edu

Locations
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United States, New York
Academic Helath Care Center - Sports Medicine Center Recruiting
Old Westbury, New York, United States, 11568
Contact: Ronald Manning, JD    516-686-1300      
Sub-Investigator: Adena Leder, DO         
Sub-Investigator: Hallie Zwibel, DO         
Sponsors and Collaborators
New York Institute of Technology
Investigators
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Principal Investigator: Sheldon Yao, DO NYITCOM

Publications:
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Responsible Party: Sheldon Yao, Associate Profession, Chair of the Department of Osteopathic Manipulative Medicine, New York Institute of Technology
ClinicalTrials.gov Identifier: NCT02750566     History of Changes
Other Study ID Numbers: BHS-1139
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Post-Concussion Syndrome
Brain Concussion
Head Injuries, Closed
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Wounds, Nonpenetrating