Osteopathic Manipulative Treatment for Head Injuries

Overseen By Aline Allera

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: New York Institute of Technology

Disqualifiers: Spinal cord injury, TBI, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study doctors to get a clear answer based on your specific situation.

What data supports the effectiveness of the treatment Osteopathic Manipulative Treatment for head injuries?

Research shows that Osteopathic Manipulative Treatment (OMT) has helped improve symptoms in people with concussions, such as nausea and dizziness, and has been beneficial for post-concussion symptoms after trauma. It may work by reducing inflammation and improving fluid flow in the brain, which can help with recovery. ^{1 2 3 4 5}

Is osteopathic manipulative treatment generally safe for humans?

The safety of osteopathic manipulative treatment (OMT) is not well-defined, as there is limited information on the frequency and severity of adverse events (unwanted effects) after treatment. More research is needed to establish a clear safety benchmark. ^{2 4 6 7 8}

How does osteopathic manipulative treatment differ from other treatments for head injuries?

Osteopathic manipulative treatment (OMT) is unique because it involves hands-on techniques to improve body mechanics and reduce inflammation, potentially enhancing recovery from head injuries like concussions. Unlike standard treatments, which are often limited and hard to personalize, OMT can address musculoskeletal restrictions and improve symptoms by enhancing glymphatic flow, which may help clear inflammation. ^{1 2 4 9 10}

Research Team

Jayme Mancini, D.O., Ph.D, FAWM

Principal Investigator

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

Reem Abu-Sbaih, D.O.

Principal Investigator

New York Institute of Technology College of Osteopathic Medicine

Amber Sousa, Ph.D

Principal Investigator

New York Institute of Technology College of Osteopathic Medicine

Eligibility Criteria

This trial is for MMA fighters or sparring participants aged 18-50 who have experienced a head hit during a fight. They must be able to complete online cognitive tests and tolerate a sports physical exam. Exclusions include spinal cord injury, recent TBI, brain degeneration, low brain hormone levels, pregnancy, intolerance to OMM (e.g., skull fracture), prolonged unconsciousness post-injury (>2 mins), seizures, persistent vomiting, or paralysis from the hit.

Inclusion Criteria

I am 18-50, do MMA, and can do online brain tests.

I witnessed a head injury during a fight.

Exclusion Criteria

I cannot have manual therapy due to severe head or neck injuries.

I have had a spinal or head injury, can't complete assessments, have a neuro condition, hypopituitary issues, or am pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-Fight Assessment

Participants undergo a non-invasive sports physical exam and cognitive neuropsychology tests before the fight

1 day

1 visit (in-person and online)

Post-Fight Assessment

Participants receive a sports physical and cognitive tests after the fight, with potential OMM or sham treatment

1 day

1 visit (in-person and online)

Follow-up

Participants are monitored for recovery and effectiveness of OMM treatment

1 week

2 visits (in-person and online)

Treatment Details

Interventions

• Osteopathic Manipulative Treatment

Trial Overview The study examines if osteopathic manipulative medicine (OMM) can aid recovery after head injuries in MMA fighters by using hands-on techniques to adjust the body. Participants may receive either OMM treatment or sham placebo-control with light touch; they won't know which one they're getting. The study involves pre- and post-fight assessments including physical exams and cognitive tests.

Participant Groups

Group I: Osteopathic manipulative medicine (OMM) Experimental Treatment 1 Intervention

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.

Group II: Control Placebo Group 1 Intervention

Sham-Light-Touch Control 30 minute sessions

Who Is Running the Clinical Trial?

New York Institute of Technology

Lead Sponsor

Trials

56

Recruited

2,300+

Findings from Research

A case study of a motor vehicle collision victim showed that osteopathic manipulative treatment (OMT) led to direct and progressive improvement in post-concussion symptoms (PCS), suggesting its potential as an effective adjunct therapy.

This report is the first to explore OMT for PCS management in polytrauma patients within an organized trauma system, highlighting the need for further research to evaluate its efficacy across various injury mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic Manipulative Treatment Relieves Post-concussion Symptoms in a Case of Polytrauma. Baltazar, GA., Kolwitz, C., Petrone, P., et al.[2020]

Osteopathic manipulative treatment (OMT) may help alleviate concussion symptoms by reducing inflammation and improving glymphatic flow, as suggested by a case study of a patient with mild concussion symptoms.

After a 25-minute OMT session, the patient experienced complete resolution of symptoms and a 6-point improvement on the Sensory Organization Test, indicating potential efficacy of OMT in concussion management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resolution of Concussion Symptoms After Osteopathic Manipulative Treatment: A Case Report. Guernsey, DT., Leder, A., Yao, S.[2017]

In a pilot study involving four patients with motion impairment and chronic cervical pain, osteopathic manipulative treatment over 3 months led to improvements in subjective complaints, physician assessments, and electrical activity of cervical spine muscles.

The study suggests that focusing on the functional aspects of neuromusculoskeletal issues can effectively guide treatment and track both subjective and objective health improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic cervical dysfunction: correlation of myoelectric findings with clinical progress. Beal, MC., Vorro, J., Johnston, WL.[2004]

In a pilot study involving 44 patients with frequent episodic tension-type headaches, osteopathic manipulative therapy (OMTh) significantly reduced headache frequency by approximately 40% after one month and 50% after three months compared to sham therapy.

The results suggest that OMTh may be a preferred treatment option for patients who experience side effects from medications or have trouble adhering to pharmacological treatments, highlighting its potential as an effective non-drug intervention for headache management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache. Rolle, G., Tremolizzo, L., Somalvico, F., et al.[2016]

In a study involving college athletes with recent concussions, those receiving osteopathic manipulative medicine (OMM) showed significant improvements in visual memory and reaction time compared to those who only received concussion education, with effect sizes indicating strong benefits for visual memory (Cohen's d=1.33).

The results suggest that OMM is a safe and effective individualized treatment for acute concussions, as evidenced by substantial recovery in neurological functions, particularly in visual memory and reaction time, warranting further research into its broader application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concussion-related visual memory and reaction time impairment in college athletes improved after osteopathic manipulative medicine: a randomized clinical trial. Mancini, JD., Angelo, N., Abu-Sbaih, R., et al.[2023]

A systematic review of 23 studies found that the majority of adverse events (AEs) following osteopathic manipulative treatment (OMT) were mild, accounting for 98% of reported AEs, indicating a generally safe profile for this treatment.

The study established a patient safety benchmark for post-OMT AEs at 1.0 AEs per 100 post-OMT interval-days, providing a reference point for future research and comparisons in patient safety within osteopathic manipulative medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model. Unger, MD., Barr, JN., Brower, JA., et al.[2023]

In a study involving 884 patients, the incidence of adverse events immediately after osteopathic manipulative treatment (OMT) was found to be low at 2.5%, with pain or discomfort being the most common complaint.

Women reported experiencing adverse events more frequently than men, suggesting a potential demographic factor in the response to OMT, but overall, the rate of adverse events was lower than those reported in other manual therapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment. Degenhardt, BF., Johnson, JC., Brooks, WJ., et al.[2022]

Osteopathic manipulative treatment (OMT) shows promising effectiveness in reducing pain and improving function for conditions like acute and chronic non-specific low back pain, chronic non-specific neck pain, and chronic non-cancer pain, based on a review of nine systematic reviews and meta-analyses involving 3740 participants.

There is limited and inconclusive evidence regarding the efficacy of OMT for pediatric conditions, primary headaches, and irritable bowel syndrome, and no adverse events were reported in most studies, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews. Bagagiolo, D., Rosa, D., Borrelli, F.[2022]

Posttraumatic headache treatment lacks standardization, highlighting the need for more defined approaches in managing this condition.

The case study of a 38-year-old woman demonstrates that a multidisciplinary approach, including osteopathic manipulative treatment, may be beneficial for patients suffering from posttraumatic headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of chronic posttraumatic headache: a multidisciplinary approach. Channell, MK., Mueller, LL., Hahn, R.[2009]

In a randomized controlled trial involving 30 participants with recent concussions, osteopathic manipulative medicine (OMM) significantly reduced both the number and severity of concussion symptoms compared to an educational intervention.

The study suggests that OMM is a safe and effective treatment option for managing new-onset symptoms of uncomplicated concussions, highlighting its potential as a personalized approach in acute care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Osteopathic Manipulative Medicine vs Concussion Education in Treating Student Athletes With Acute Concussion Symptoms. Yao, SC., Zwibel, H., Angelo, N., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Osteopathic Manipulative Treatment Relieves Post-concussion Symptoms in a Case of Polytrauma. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Resolution of Concussion Symptoms After Osteopathic Manipulative Treatment: A Case Report. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Chronic cervical dysfunction: correlation of myoelectric findings with clinical progress. [2004]

4. United States pubmed.ncbi.nlm.nih.gov

Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache. [2016]

5. Germany pubmed.ncbi.nlm.nih.gov

Concussion-related visual memory and reaction time impairment in college athletes improved after osteopathic manipulative medicine: a randomized clinical trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Management of chronic posttraumatic headache: a multidisciplinary approach. [2009]

10. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Osteopathic Manipulative Medicine vs Concussion Education in Treating Student Athletes With Acute Concussion Symptoms. [2022]