NCT06851234 · New York Institute of Technology
Osteopathic Manipulative Treatment RCT and Computational Modeling for Head Injuries in Mixed Martial Artists
What this study is about
The purpose is to test how osteopathic medicine (OMM) improves recovery after a hit to the head during Mixed Martials Arts (MMA). The small changes in the bone, joints, and fluids during head injuries may lead to traumatic brain injury (TBI). The OMM is adjusting the body with the doctors' hands. The goal is to restore alignment and release tension.
View original scientific description
The purpose is to test how osteopathic medicine (OMM) improves recovery after a hit to the head during Mixed Martials Arts (MMA). The small changes in the bone, joints, and fluids during head injuries may lead to traumatic brain injury (TBI). The OMM is adjusting the body with the doctors' hands. The goal is to restore alignment and release tension. The head is treated with the doctors' hands placed gently on the head or face. It was previously found to improve symptoms and recovery of memory after head injuries in college athletes. There haven't been clinical trials of this procedure in MMA fighters. Yet, they often get injuries to the part of the brain that releases hormones. Referrals for tests for the hormones are available. Individuals who participate in MMA fighting or sparring matches may join this study. Those who don't get hit in the head or a concussion will contribute to our understanding the osteopathic structural physical exam and fluid dynamics of the head in relation to brain function tests. Those who get hit in the head may be put in the treatment procedure or sham-placebo group. Participants will not be told which group they are in. We anticipate that 100 individuals of any gender will enroll in this study at NYIT Academic Health Care Center (AHCC). To be in this study, the participant must: Part 1 - Before the fight: 1. Plan to participate in an MMA fight or sparring match, 2. 18 to 50 years of age, 3. Be able to do online cognitive neuropsychology tests for memory, reaction time, and symptoms. Part-2-After the fight: (1) Have been hit in the head, or had a head injury, during a fight The participant cannot be in this study if they have: Part 1- Before the fight: 1. a current or previous spinal cord injury, 2. a traumatic brain injury within the past six months, 3. inability to tolerate the sports physical, 4. a diagnosis of brain degeneration, 5. low hormones levels from the brain, 6. Pregnancy Participants won't get referred for hormone testing if they don't have any clinical signs of this injury. They also won't get referred for it if they've had heart disease, disease of the blood vessels in their brain, or seizures. Participants cannot be in Part-2-After the fight if they: 1. cannot tolerate OMM (For example, you have a skull fracture, cervical spine fracture, bleeding or increased pressure in the head, tearing of tissues in the neck, space-occupying lesion, or stroke). 2. were knocked out for more than 2 minutes, had seizures, persistent vomiting, or paralysis when your head was hit. Participation involves 2 or 4 visits, which will take place over one week. * The first visit takes 30 mins. in-person and 70 mins. of online testing from home. * The second visit takes 30-60 mins. in-person and 70 mins. of online testing from home. * The third \& fourth visits will each be 30 mins. in-person and 70 mins. online testing from home. If participants agree to be in this study, they will be asked to do the following: Visit #1: Before the Fight * Get screened and review the consent form * Take the neuropsychology tests (ImPACT and Inquisit Web) online from home * Get a non-invasive sports physical exam of head, neck, back, arms, and legs. * Urine sample for the hormone from the brain called oxytocin (optional) * Have blood sugar checked by a lancet after pricking the finger (optional) Fight video: The study-doctors will record the participants' fights to make a computational model of the head. Visit 2: After the Fight * Get a sports physical of head, neck, back, arms, and legs. * IF the participant was hit in the head, the study-doctors or participants private doctor will examine them. * Take the ImPACT and Inquisit Web tests online from home * If the participant had an injury to their brain, they may get the OMM procedure or sham placebo-control (non-therapeutic light touch). * Urine sample for the hormone from the brain called oxytocin (optional) * Have your blood sugar checked by a lancet after pricking your finger (optional) * Referral to your doctor to test the levels of other brain hormone (optional) Visit 3 \& 4: * Sports physical of head, neck, back, arms, and legs * Take the ImPACT and Inquisit Web tests online from home * If you had an injury to your brain, you may get the OMM procedure or sham placebo-control (nontherapeutic light touch). You will not be told which one you are getting. * Urine sample for oxytocin (optional) * Have blood sugar checked by a lancet after pricking your finger (optional) * Referral to test the levels of other brain hormone (optional) Any significant new findings that develop during research that may relate to the participants health or willingness to continue will be provided to them by phone call. The results will help us understand head injuries, how well OMM works to treat them, and may improve future care for fighters.
Interventions
PROCEDURE
osteopathic manipulative medicine
OMM
PROCEDURE
The sham light touch will be performed by an investigator not trained in bodywork or a first--year osteopathic medical student.
Participants will lay supine on an OMM table. After the OSE, the investigator will place their hands flat in light contact with the participants' parietal bone regions, then the shoulders, then the sides of the lower ribs, and finally over the trochanters.
Primary outcome measures
Osteopathic structural exam
Time frame: 1 week
Osteopathic structural exam is a detailed physical exam of the biophysical characteristics such as biomechanical alignment. Testing will be done pre-fight, post-fight, and after the two follow up visits.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Part 1-head injury dynamics:
- individuals participating in MMA fights or sparring matches,
- 18 to 50 years of age,
- able to complete online cognitive neuropsychology tests. Part-2-Intervention: <!-- -->
- having a witnessed closed head injury during a fight
Exclusion criteria
- Part 1-head injury dynamics:
- having a current or previous spinal cord injury,
- head injury within past six months,
- being unable to complete the assessment,
- been diagnosed with underlying neurodegenerative condition,
- pre-existing hypopituitary function,
- Pregnancy. Part-2-Intervention:
- has absolute contraindications to OMM (e.g. skull fracture, cervical spine fracture, signs of intracranial bleeding or increased intracranial pressure, cervical dissection, space occupying lesion in the cranium, or stroke),
- suffered a witnessed loss of consciousness (LOC) for greater than 2 minutes, seizures, intractable vomiting or paralysis at the time of the head injury, Participants won't be referred to their private doctors for additional pituitary hormone testing unless there are clinical signs. The optional referral for growth hormone and other pituitary testing by glucagon stimulation Test at Quest labs will be contraindicated if there is risk of and/or a history of (1) cardiovascular (heart) disease, (2) disease of the blood vessel in your brain, or (3) seizures.
Where
- Greenvale, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 28, 2025 · Source of record for eligibility and locations