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OMT + Counseling for Post-Concussion Syndrome and Vestibular Dysfunction
N/A
Waitlist Available
Led By Sheldon Yao, DO
Research Sponsored by New York Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured on day 1, day 3, and day 7 post concussion
Awards & highlights
Study Summary
This trial is testing whether osteopathic manipulative treatment can help reduce symptoms of concussion compared to counseling.
Eligible Conditions
- Post-Concussion Syndrome
- Vestibular Dysfunction
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured on day 1, day 3, and day 7 post concussion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured on day 1, day 3, and day 7 post concussion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
SMART Balance Master balance scores pre and post intervention arm
Secondary outcome measures
Post-concussion symptoms as measured by ImPACT
Post-concussion symptoms as measured by King-Devick
Post-concussion symptoms as measured by SCAT-3
Other outcome measures
Return to play time
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Osteopathic Manipulative TreatmentExperimental Treatment1 Intervention
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.
Group II: CounselingActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osteopathic Manipulative Treatment
2008
Completed Phase 4
~2530
Find a Location
Who is running the clinical trial?
New York Institute of TechnologyLead Sponsor
51 Previous Clinical Trials
2,031 Total Patients Enrolled
Sheldon Yao, DOPrincipal Investigator - NYITCOM
New York Institute of Technology
3 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a current or past injury to your spinal cord.You were unconscious for more than 2 minutes after the injury that caused the concussion.You had a seizure when you got the concussion.You have uncontrollable vomiting when you had a concussion.You don't have any serious head or neck injuries that would make osteopathic treatment unsafe.You recently had a head injury and are still experiencing symptoms related to a concussion.You have been diagnosed with a concussion.You were unable to move at the time of the incident that caused the concussion.You have a brain condition like Parkinson's or Alzheimer's that could affect the test results.
Research Study Groups:
This trial has the following groups:- Group 1: Counseling
- Group 2: Osteopathic Manipulative Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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