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
|Condition or disease||Intervention/treatment||Phase|
|Post-Concussion Symptoms Distorted; Balance||Procedure: Osteopathic Manipulative Treatment Other: Counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
Patients will be counseled on concussion awareness, symptoms, and treatment for 30 minutes by a physician.
- 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
- 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
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750566
|Contact: Sheldon C Yao, DOfirstname.lastname@example.org|
|Contact: Adena Leder, DOemail@example.com|
|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|
|Principal Investigator:||Sheldon Yao, DO||NYITCOM|