Comparing the Effect of Osteopathic Manipulative Medicine (OMM) Versus Counseling in the Treatment of Concussion

NCT02750566 | Completed

• 1 other identifier: BHS-1139
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Concussion or mild traumatic brain injury (TBI) is a challenging injury for physicians to manage and is among the most serious disabling neurological disorders. Physician awareness regarding manifestations of TBI and subsequent treatment are paramount to reduce the burden of disease. Advancements in treatment of mild TBI have been slow with a lack of consensus on treatment methods that show universal success. This gap in treatment choices provides an opportunity for osteopathic manipulative treatment (OMT) to fill. OMT is a hands-on manual therapy that can be integrated to help treat post-concussive symptoms. Previous studies have shown that OMT can help resolve imbalance and tinnitus in elderly populations and case studies have shown that this manual therapy may assist in patient recovery. The investigators hypothesize that OMT will decrease return to play/work time, will show an improvement in balance, and will decrease concussion symptoms as compared to counseling.

Conditions

Post-Concussion Symptoms; Distorted; Balance

Outcome Measures

Primary Outcomes (1)

• SMART Balance Master balance scores pre and post intervention arm

  OMT should show a statistically significant improvement in balance as measured by SMART Balance Master balance scores as measured by change pre and post procedure

  change from the pre-intervention score after the intervention, measured at each visit through study completion, an average of 1 week after the initial visit

Secondary Outcomes (3)

• Post-concussion symptoms as measured by ImPACT

  measured on day 1, day 3, and day 7 post concussion

• Post-concussion symptoms as measured by King-Devick

  measured on day 1, day 3, and day 7 post concussion

• Post-concussion symptoms as measured by SCAT-3

  measured on day 1, day 3, and day 7 post concussion

Other Outcomes (1)

• Return to play time

  Up to 90 days

Study Arms (2)

Osteopathic Manipulative Treatment

EXPERIMENTAL

A board certified NMM/OMM or FP/OMM physician will perform an osteopathic structural exam and osteopathic treatment for a 30 minute session. The investigators will follow a generalized protocol for diagnosis and treatment of the head, neck, spine, rib cage, and pelvis. The following techniques will be included in the treatment protocol, OA (Occipitoatlantal) decompression, V-Spread, venous sinus drainage, balanced membranous tension (BMT), cranial lifts, CV4, and a mix of balanced ligamentous tension (BLT), muscle energy techniques, facilitated positional release, articulatory techniques (ART), high-velocity low-amplitude, and counterstrain to address any somatic dysfunctions.

Procedure: Osteopathic Manipulative Treatment

Counseling

ACTIVE COMPARATOR

For the control group, an investigator will complete a 30-minute counseling session with the subject. The focus of discussion will be from the CDC's "What to expect after a concussion" article. Other resources that will also be used come from the American Academy of Family Physicians (AAFP), FamilyDoctor.org, and the Brain Care Center. Each counseling session will follow the same protocol. The counseling session will provide subject with similar face-to-face time with the OMT arm.

Other: Counseling

Interventions

Osteopathic Manipulative Treatment PROCEDURE

Manual treatment of musculoskeletal restrictions that may be prevent proper healing post-concussion.

Also known as: Osteopathic Manipulative Medicine

Osteopathic Manipulative Treatment

Counseling OTHER

Patients will be counseled on concussion awareness, symptoms, and treatment for 30 minutes by a physician.

Counseling

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is at least 18 years age
• Subject has suffered from non-life threatening head trauma head trauma resulting in current concussion-related symptoms
• Subject is evaluated and diagnosed with a concussion
• Subject has been cleared to participate in the study by the physician/neurologist having excluded any potential emergent conditions

You may not qualify if:

• The subject has no absolute contraindications to osteopathic manipulative treatment, such as skull fracture, cervical fracture, signs of intracranial bleeding, cervical dissection, or stroke
• The subject suffered from any of the following at the time of event leading to concussion:
• Loss of consciousness \>2 minutes in the field
• Seizures
• Intractable vomiting
• Paralysis
• The subject has been diagnosed with an underlying neurodegenerative condition that may confound test results (e.g.. Parkinson's Disease, Alzheimer's Disease)
• The subject has a current or previous spinal cord injury
• The subject is unable to complete the assessment tools
• The subject is pregnant

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

Academic Helath Care Center - Sports Medicine Center

Old Westbury, New York, 11568, United States

Location

Related Publications (7)

• Fraix M, Gordon A, Graham V, Hurwitz E, Seffinger MA. Use of the SMART Balance Master to quantify the effects of osteopathic manipulative treatment in patients with dizziness. J Am Osteopath Assoc. 2013 May;113(5):394-403.

  PMID: 23667193 BACKGROUND

• King D, Gissane C, Hume PA, Flaws M. The King-Devick test was useful in management of concussion in amateur rugby union and rugby league in New Zealand. J Neurol Sci. 2015 Apr 15;351(1-2):58-64. doi: 10.1016/j.jns.2015.02.035. Epub 2015 Feb 26.

  PMID: 25748294 BACKGROUND

• Schatz P, Pardini JE, Lovell MR, Collins MW, Podell K. Sensitivity and specificity of the ImPACT Test Battery for concussion in athletes. Arch Clin Neuropsychol. 2006 Jan;21(1):91-9. doi: 10.1016/j.acn.2005.08.001. Epub 2005 Sep 6.

  PMID: 16143492 BACKGROUND

• Guskiewicz KM, Register-Mihalik J, McCrory P, McCrea M, Johnston K, Makdissi M, Dvorak J, Davis G, Meeuwisse W. Evidence-based approach to revising the SCAT2: introducing the SCAT3. Br J Sports Med. 2013 Apr;47(5):289-93. doi: 10.1136/bjsports-2013-092225.

  PMID: 23479486 BACKGROUND

• Corps KN, Roth TL, McGavern DB. Inflammation and neuroprotection in traumatic brain injury. JAMA Neurol. 2015 Mar;72(3):355-62. doi: 10.1001/jamaneurol.2014.3558.

  PMID: 25599342 BACKGROUND

• Mazzeo S, Silverberg C, Oommen T, Moya D, Angelo N, Zwibel H, Mancini J, Leder A, Yao SC. Effects of Osteopathic Manipulative Treatment on Sleep Quality in Student Athletes After Concussion: A Pilot Study. J Am Osteopath Assoc. 2020 Aug 11. doi: 10.7556/jaoa.2020.100. Online ahead of print.

  PMID: 32780797 DERIVED

• Yao SC, Zwibel H, Angelo N, Leder A, Mancini J. Effectiveness of Osteopathic Manipulative Medicine vs Concussion Education in Treating Student Athletes With Acute Concussion Symptoms. J Am Osteopath Assoc. 2020 Aug 7. doi: 10.7556/jaoa.2020.099. Online ahead of print.

  PMID: 32766808 DERIVED

MeSH Terms

Conditions

Post-Concussion Syndrome

Interventions

Manipulation, Osteopathic; Counseling

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sheldon Yao, DO

  NYITCOM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profession, Chair of the Department of Osteopathic Manipulative Medicine

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: April 25, 2016
• Study Start: November 15, 2015
• Primary Completion: June 1, 2019
• Study Completion: October 4, 2023
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)