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Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy

M

Matthew T. Mcelroy, DO

Status

Terminated

Conditions

Concussion, Brain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04063618
2019-0612

Details and patient eligibility

About

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.

Full description

Concussion incidence in high school and collegiate sports is high, especially in football. These injuries have become the focus of the sports world, as coaches, trainers, and medical personnel are more vigilant than ever in screening for concussions. 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 can be used to decrease the severity and the duration of this symptom. In a prospective superiority comparison between standard of care for concussion (rest and return to play protocol) and a single OMT treatment in combination with standard therapy, we hypothesize that OMT decreases symptom duration and severity of headache in concussion management.

Enrollment

1 patient

Sex

All

Ages

Under 24 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1 participants in 2 patient groups

Osteopathic Manipulative Therapy (OMT) Treatment Group
Experimental group
Description:
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.
Treatment:
Procedure: Osteopathic Manipulative Therapy
Procedure: Standard of Care Concussion Treatment
Standard of care concussion treatment group
Active Comparator group
Description:
Standard of care concussion treatment without OMT
Treatment:
Procedure: Standard of Care Concussion Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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