Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy

NCT04063618 | Terminated

• 1 other identifier: 2019-0612
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Concussion incidence in high school and collegiate sports is high, especially in football. Once diagnosed, return to play is dependent on recovery from symptoms followed by a specific protocol for clearance; the sooner the symptoms subside the sooner the protocol is initiated. Osteopathic Manipulative Therapy (OMT) is a low risk procedure that has minimal side effects and has been used to decrease both headache intensity and frequency. With the main subjective symptom tracked for concussion being headache, OMT may be used to decrease the severity and the duration of this symptom.

Conditions

Concussion, Brain

Outcome Measures

Primary Outcomes (3)

• Concussion Severity Score

  Patient will score him or herself on a scale from 0-6 for each of 22 concussion related symptoms. A score of "0" is equal to no symptoms, a score of 1-2 is mild, a score of 3-4 is moderate, a score of 5-6 is severe. Total score is calculated by adding each individual item score. Higher scores are worse than lower scores.

  7 days

• Duration of concussion symptoms

  Measured in days; how does Concussion Severity Score change over time

  7 days

• Time to start of the return to play protocol

  Measured in days; Once diagnosed, return to play is dependent on recovery from symptoms followed by a specific protocol for clearance; the sooner the symptoms subside the sooner the protocol is initiated.

  7 days

Study Arms (2)

Osteopathic Manipulative Therapy (OMT) Treatment Group

EXPERIMENTAL

Initial concussion treatment will involve OMT in addition to standard of care treatment. The OMT practitioner, using a strong anatomic knowledge base, applies specific genital forces in the dysfunctional area, thus providing aid to the body's innate mechanisms of healing. During OMT, a patient's muscles and joints are moved using techniques that include stretching, gentle pressure, and resistance.

Procedure: Osteopathic Manipulative Therapy; Procedure: Standard of Care Concussion Treatment

Standard of care concussion treatment group

ACTIVE COMPARATOR

Standard of care concussion treatment without OMT

Procedure: Standard of Care Concussion Treatment

Interventions

Osteopathic Manipulative Therapy PROCEDURE

The OMT practitioner, using a strong anatomic knowledge base, applies specific genital forces in the dysfunctional area, thus providing aid to the body's innate mechanisms of healing. During OMT, a patient's muscles, joints, and tissues are moved using techniques that include stretching, gentle pressure, and resistance.

Osteopathic Manipulative Therapy (OMT) Treatment Group

Standard of Care Concussion Treatment PROCEDURE

Standard of care for concussion management is cognitive rest, meaning no stimulation (or as little as possible). This mean no TV/phones/music/school/homework generally for 24 hours. After that a return to academic work is typically started. Once patient is symptom free for 24 hours, then the return to play protocol is initiated (this takes 7 total days to complete at a minimum).

Osteopathic Manipulative Therapy (OMT) Treatment Group; Standard of care concussion treatment group

Eligibility Criteria

• Age: Up to 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients referred to the Geisinger sports medicine clinic or athletic training room for concussion evaluation and management
• Age less than 25 years old
• Enrolled in high school or college
• Participating in a sport at either collegiate or high school level

You may not qualify if:

• Diagnosis does not meet criteria for concussion
• Symptoms of concussion not present on initial visit
• Patient unable to tolerate the OMT treatment
• Patient needs intervention beyond standard concussion management
• Patients not able to provide consent to be a part of the study

Sponsors & Collaborators

• Matthew T. Mcelroy, DO: lead

Study Sites (1)

Geisinger Woodbine

Danville, Pennsylvania, 17821, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Matthew McElroy, DO

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: December 3, 2019
• Primary Completion: November 16, 2021
• Study Completion: November 16, 2021
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

US (1)