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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if osteopathic manipulative treatment (OMT), which involves adjusting the body using a doctor's hands, can aid recovery after a head injury in MMA fighters. The focus is on whether this treatment can improve issues like memory and hormone release following a head hit. Participants will receive either the OMT treatment or a placebo (fake treatment) without knowing which one they receive. MMA fighters who have been hit in the head during a fight and can complete online tests are suitable candidates for this trial. The study will take place at the NYIT Academic Health Care Center. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance recovery methods for athletes.

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 prior data suggests that this osteopathic manipulative treatment is safe for head injuries?

Research has shown that osteopathic manipulative treatment (OMT) is generally safe for treating symptoms after a concussion. One study found that it can help people recover from these symptoms safely. Another study demonstrated that OMT can alleviate dizziness and neck pain, common after a concussion. These studies suggest that OMT is well-tolerated and does not cause major side effects.

While the current trial focuses on a specific group—MMA fighters—OMT has been used safely in other athletes with head injuries. No major harmful side effects have been reported in these cases. Therefore, strong evidence from past research supports the safety of OMT for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Osteopathic Manipulative Treatment (OMT) for head injuries because it offers a unique approach that goes beyond traditional symptom management, which often involves medications like pain relievers and anti-inflammatories. Unlike these standard treatments, OMT focuses on using hands-on techniques to improve bodily function and promote healing. This method aims to optimize lymphatic and glymphatic circulation, potentially reducing inflammation and enhancing recovery. By addressing the root physical dysfunctions caused by head injuries, OMT could provide an innovative way to aid recovery more holistically.

What evidence suggests that osteopathic manipulative treatment is effective for head injuries?

Research has shown that osteopathic manipulative treatment (OMT), which participants in this trial may receive, can alleviate symptoms after a concussion. It improves dizziness and neck pain, common post-concussion issues. Some studies suggest it also helps with headaches and anxiety following head injuries. In college athletes, OMT has been reported to aid memory recovery after head injuries. While evidence for MMA fighters is limited, this treatment aims to realign the body and reduce tension, potentially supporting recovery after head impacts. ^{1 2 3 6 7}

Who Is on the 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

Amber Sousa, Ph.D

Principal Investigator

New York Institute of Technology College of Osteopathic Medicine

Reem Abu-Sbaih, D.O.

Principal Investigator

New York Institute of Technology College of Osteopathic Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41196934/

Osteopathic manipulative treatment in the management of ... Osteopathic manipulative treatment (OMT) can be utilized as a primary or adjunctive treatment for headaches associated with musculoskeletal ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02750566

Comparing the Effect of Osteopathic Manipulative Medicine ... Purpose: The purpose of this study is to investigate the effectiveness of osteopathic manipulative treatment (OMT) in improving concussion-related symptoms.

3. acofp.org acofp.org/docs/default-source/ofp/vol-7-no-4-(2015)-july-august-2015/assessing-the-immediate-effect-on-osteopathic-manipulation-on-sports-related-concussion-symptoms.pdf?sfvrsn=3dc4fae8_0

assessing-the-immediate-effect-on-osteopathic- ... Background: Osteopathic manipulative therapy has been reported to improve dizziness and neck pain, which are symptoms commonly seen in concussion. Conceivably ...

4. academic.oup.com academic.oup.com/milmed/article-abstract/190/11-12/e2632/7984090

Osteopathic Manipulative Treatment for Postconcussive ... She was treated with osteopathic manipulative treatment (OMT), which helped resolve her headaches and her anxiety. The OMT techniques applied during treatment ...

5. jom.osteopathic.org jom.osteopathic.org/abstract/osteopathic-manipulative-treatment-for-concussions-and-postconcussive-syndrome-in-athletes-a-literature-review/

Osteopathic manipulative treatment for concussions and ... Osteopathic manipulative treatment for concussions and postconcussive syndrome in athletes: a literature review · Kevin D. Thomas, DO,. HCA ...

6. europepmc.org europepmc.org/article/med/29710088

Safety of Osteopathic Cranial Manipulative Medicine as an ... Conclusions. Osteopathic cranial manipulative medicine was considered a safe adjunctive treatment option to improve concussion-related symptoms and recovery.

7. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2777527

Effect of Osteopathic Manipulative Treatment vs Sham ... This randomized clinical trial compares the efficacy of standard vs sham osteopathic manipulative treatment for reducing activity ...