Concussion, BrainNCT04063618
Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy
A study testing Osteopathic Manipulative Therapy in people with Concussion, Brain, run by Matthew T. Mcelroy, DO at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 years
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- Osteopathic Manipulative Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2019to 16 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy: A Prospective Study
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.
Read the detailed 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.
- Conditions
- Concussion, Brain
- Being tested
- Osteopathic Manipulative Therapy, Standard of Care Concussion Treatment
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TherapyProcedure or surgery
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.
Standard of Care Concussion TreatmentProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Standard of Care Concussion Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Duration of concussion symptoms
Measured in days; how does Concussion Severity Score change over time
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start3 Dec 2019
- Primary completion16 Nov 2021
- Study completion16 Nov 2021
Why it stopped: Insufficient subject enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew T. Mcelroy, DO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew T. Mcelroy, DO, Geisinger Clinic
- Investigators
- Matthew McElroy, DO, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063618
- Sponsor's protocol ID
- 2019-0612
- Status last verified
- Mar 2023
- First submitted
- 19 Aug 2019
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy: A Prospective Study
- ClinicalTrials.gov ID
- NCT04063618
- Acronym / sponsor ID
- 2019-0612
- Conditions
- Concussion, Brain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient subject enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Matthew T. Mcelroy, DOUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Therapy (OMT) Treatment Group | Experimental | Procedure: Osteopathic Manipulative Therapy, Procedure: Standard of Care Concussion TreatmentInitial 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. |
| Standard of care concussion treatment group | Active comparator | Procedure: Standard of Care Concussion TreatmentStandard of care concussion treatment without OMT |
Who may qualify
- Ages
- Up to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TherapyThe 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. | Procedure or surgery | Osteopathic Manipulative Therapy (OMT) Treatment Group |
| Standard of Care Concussion TreatmentStandard 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). | Procedure or surgery | Osteopathic Manipulative Therapy (OMT) Treatment Group, Standard of care concussion treatment group |
Primary outcome
Concussion Severity Score
Time frame: 7 days
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.
Duration of concussion symptoms
Time frame: 7 days
Measured in days; how does Concussion Severity Score change over time
Time to start of the return to play protocol
Time frame: 7 days
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.
Results and safety
The study was stopped early (reason given: Insufficient subject enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew McElroy, DO principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Therapy in people with Concussion, Brain, run by Matthew T. Mcelroy, DO at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient subject enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concussion Severity Score (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.