Osteopathic Manipulative Treatment RCT and Computational Modeling for Head Injuries in Mixed Martial Artists

Summary

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.

Conditions

• Head Injury Trauma

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.

Sponsors & Collaborators

• New York Institute of Technology

  lead OTHER

Principal Investigators

• Jayme Mancini, D.O., Ph.D, FAWM · New York Institute of Technology College of Osteopathic Medicine, Academic Health Care Center, Riland Building

• Amber Sousa, Ph.D · New York Institute of Technology College of Osteopathic Medicine

• Reem Abu-Sbaih, D.O. · New York Institute of Technology College of Osteopathic Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-01

Primary Completion

2026-03-01

Completion

2026-12-01

Countries

• United States

Study Locations