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

NCT06851234 | Recruiting DMC

• 2 other identifiers: BHS2024 13524007886
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

osteopathic manipulative treatment; concussion; mixed martial arts; head injury

Outcome Measures

Primary Outcomes (1)

• Osteopathic structural exam

  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.

  1 week

Secondary Outcomes (1)

• ImPACT and Inquisit Web cognitive neuropsychology tests

  1 year

Other Outcomes (1)

• Brain region found at the point of cerebrospinal fluid flux during contrecoup of brain during head injury

  3 days

Study Arms (2)

Osteopathic manipulative medicine (OMM)

EXPERIMENTAL

Intervention Goals: The varied vectors of head injuries potentially leading to concussion necessitate the initial (Part A) techniques to be individualized to the participant and their OSE. Part B is required techniques to optimize lymphatic and/or glymphatic circulation as outlined below. All investigators (JDM, RAS, PK) who perform OMM will meet to discuss treatment approaches to best achieve consistency. 1. Cranial 15 min. Part A: treatment of any new somatic dysfunctions and cranial lifts for suture compressions. Part B: Thoracic outlet release, OA decompression, V-Spread, Venous sinus drainage, cranial-OMM for strain patterns, facial effleurage, and Cranial treatments will end with a CV4. 2. Spine 5 min. Use of appropriate techniques for the dysfunctions, such as Balanced ligamentous tension (BLT), muscle energy techniques, facilitated positional release, articulatory techniques (ART), high-velocity low-amplitude, and counterstrain. 3. Rib Cage 5 min. 4. Sacrum/Pelvis 5 min.

Procedure: osteopathic manipulative medicine

Control

SHAM COMPARATOR

Sham-Light-Touch Control 30 minute sessions

Procedure: The sham light touch will be performed by an investigator not trained in bodywork or a first--year osteopathic medical student.

Interventions

osteopathic manipulative medicine PROCEDURE

OMM

Osteopathic manipulative medicine (OMM)

The sham light touch will be performed by an investigator not trained in bodywork or a first--year osteopathic medical student. PROCEDURE

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.

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Part 1-head injury dynamics:
• individuals participating in MMA fights or sparring matches,
• to 50 years of age,
• able to complete online cognitive neuropsychology tests.
• Part-2-Intervention:
• <!-- -->
• having a witnessed closed head injury during a fight

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

Academic Health Care Center of NYIT College of Osteopathic Medicine

Greenvale, New York, 11568, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Craniocerebral Trauma

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Jayme Mancini, D.O., Ph.D, FAWM

  New York Institute of Technology College of Osteopathic Medicine, Academic Health Care Center, Riland Building

  PRINCIPAL INVESTIGATOR

• Amber Sousa, Ph.D

  New York Institute of Technology College of Osteopathic Medicine

  STUDY DIRECTOR

• Reem Abu-Sbaih, D.O.

  New York Institute of Technology College of Osteopathic Medicine

  STUDY CHAIR

Central Study Contacts

Milan Toma, Ph.D, SMIEEE

CONTACT

516-686-3799; tomamil@tomamil.com

Aline Allera

CONTACT

5166867438; aallera@nyit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding: The investigators measuring cognitive neuropsychology and computational modeling will be blinded to grouping, and the investigators performing the OSE will be blinded to each others' diagnoses as well as the other outcome measures. If there are any concerns for health identified on cognitive neuropsychology testing, Dr. Amber Sousa, Ph.D is a clinical neuropsychologist who can direct participants for appropriate care.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The pre-fight outcome measures, computational modeling of any head injury during the fight, and the post-fight outcome measures will be done on all research participants. If the participant did sustain a head injury or concussion, then, they would be randomly put in the OMM treatment or Sham treatment groups.

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 28, 2025
• Study Start: November 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-01

Locations

US (1)