Comparing the Effect of Osteopathic Manipulative Medicine (OMM) Versus Counseling in the Treatment of Concussion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- SMART Balance Master balance scores pre and post intervention arm
Study Overview
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.
Detailed Description
Purpose:
The purpose of this study is to investigate the effectiveness of osteopathic manipulative treatment (OMT) in improving concussion-related symptoms.
Previous studies and case reports have found a positive effect of OMT on resolving concussion-like symptoms such as vertigo, imbalance, and tinnitus. It is hypothesized that OMT improves proprioceptive input from the cervical spine and joints and sensory input from the internal auditory meatus. The investigators propose to further investigate this relationship in order to quantify the effect of OMT through the SMART Balance Master and return to play/work time. As this is a pilot study, the investigators intend to determine if a correlation exists between OMT and return to work/play and SMART Balance Master scores.
Specifically, the investigators have three main aims for this study:
Specific Aim #1: OMT will show a statistically significant improvement balance as measured by the SMART Balance Master scores pre- and post-OMT
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
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.
Intervention: Osteopathic Manipulative Treatment (Procedure)
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.
Intervention: Counseling (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Post-concussion symptoms as measured by SCAT-3(measured on day 1, day 3, and day 7 post concussion)
- Post-concussion symptoms as measured by King-Devick(measured on day 1, day 3, and day 7 post concussion)
- Post-concussion symptoms as measured by ImPACT(measured on day 1, day 3, and day 7 post concussion)
Investigators
Sheldon Yao
Associate Profession, Chair of the Department of Osteopathic Manipulative Medicine
New York Institute of Technology