Comparing the Effect of Osteopathic Manipulative Medicine (OMM) Versus Counseling in the Treatmen… (NCT02750566) | Clinical Trial Compass
CompletedNot Applicable
Comparing the Effect of Osteopathic Manipulative Medicine (OMM) Versus Counseling in the Treatment of Concussion
United States33 participantsStarted 2015-11-15
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SMART Balance Master balance scores pre and post intervention arm
Timeframe: 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