Concussion Injury of CerebrumNCT03225599
Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion
A study testing Cranial Osteopathic Manipulative Medicine in people with Concussion Injury of Cerebrum and Cranial Osteopathic Medicine, run by Northwell Health.
Trial summary
Patients who have concussions exhibit an array of symptoms, also known as post-concussive symptoms, including headaches, feeling slowed down or foggy and difficulty with concentration. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Concussion Injury of Cerebrum, Cranial Osteopathic Medicine
- What is being tested?
- Cranial Osteopathic Manipulative Medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 9 Feb 2010to 26 Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Concussion occurred within 8 weeks
- Age greater or equal to 14 years
- Complains of post-concussive symptoms with a symptom score of >10 on PCSS
Who cannot join
- Concussion occurred > 8 weeks
- Age less than 14 years
- Surgery of the cervical and/or thoracic spine within the last 3 months
- Currently receiving or has received workers compensation within the last 3 months
- Currently or potentially become involved in litigation related to the injury
- Received osteopathic craniosacral treatments within the last 3 months
- History of hydrocephalus, current infection or active tumor
- Active or marked depression, anxiety or psychosis
About this study
Patients who have concussions exhibit an array of symptoms, also known as post-concussive symptoms, including headaches, feeling slowed down or foggy and difficulty with concentration. This study aims to determine if cranial osteopathy can provide additional or expedited symptom relief when accompanying current conventional treatments. The patients will be identified through routine clinical contact. If patients are found to be eligible and agree to participate, they receive a single session of cranial osteopathy in addition to their usual care through the concussion program.
- Being tested
- Cranial Osteopathic Manipulative Medicine
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial Osteopathic Manipulative MedicineOther
The hands will be placed on the head using the "vault hold" (bilateral thumbs are off the head, index fingers on the temporal bones, middle fingers on the sphenoid bones, ring fingers on the mastoid and the 5th fingers on the occipital bone). Diagnosis and treatment of restrictions palpated on the scalp will be made using this hand position
| Study group | Role | What they receive |
|---|---|---|
| Procedure | Experimental | Not described Receives: Other: Cranial Osteopathic Manipulative Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Concussive Symptoms on the Post Concussion Symptom Scale
The Post Concussion Symptom Scale (PCSS) is a scale used to subjectively measure concussion symptoms. The minimum score is 0 and the maximum score is 132 (a maximum score of 6 for 22 items). The higher the value the worse the symptom. Twenty-two possible symptoms are graded and are the following:Headache, Nausea, Vomiting, Balance Problems, Dizziness, Lightheadedness, Fatigue, Trouble falling asleep, Sleeping more than usual, Sleeping less than usual, Drowsiness, Sensitivity to light, Sensitivity to noise, Irritability, Sadness, Nervous/Anxious, Feeling more emotional, Numbness or tingling, Feeling slowed down, Feeling like "in a fog," Difficulty concentrating, Difficulty remembering, and/or Visual problems. Total score can range from 0 to 132. Units of a scale is used.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start9 Feb 2010
- Primary completion30 Jun 2010
- Study completion26 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Concussion Injury of CerebrumStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Responsible party
- Principal investigator, Rosanna C. Sabini, DO, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225599
- Sponsor's protocol ID
- Concussion COMM
- Status last verified
- Jun 2019
- First submitted
- 14 Jul 2017
- Last updated
- 25 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion
- ClinicalTrials.gov ID
- NCT03225599
- Acronym / sponsor ID
- Concussion COMM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Study start
- 9 Feb 2010 (actual)
- Primary completion
- 30 Jun 2010 (actual)
- Study completion
- 26 Jan 2013 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who have concussions exhibit an array of symptoms, also known as post-concussive symptoms, including headaches, feeling slowed down or foggy and difficulty with concentration. This study aims to determine if cranial osteopathy can provide additional or expedited symptom relief when accompanying current conventional treatments. The patients will be identified through routine clinical contact. If patients are found to be eligible and agree to participate, they receive a single session of cranial osteopathy in addition to their usual care through the concussion program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Procedure | Experimental | Other: Cranial Osteopathic Manipulative Medicine |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Concussion occurred within 8 weeks
- Age greater or equal to 14 years
- Complains of post-concussive symptoms with a symptom score of >10 on PCSS
Key exclusion criteria (8 listed)
- Concussion occurred > 8 weeks
- Age less than 14 years
- Surgery of the cervical and/or thoracic spine within the last 3 months
- Currently receiving or has received workers compensation within the last 3 months
- Currently or potentially become involved in litigation related to the injury
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 |
|---|---|---|
| Cranial Osteopathic Manipulative MedicineThe hands will be placed on the head using the "vault hold" (bilateral thumbs are off the head, index fingers on the temporal bones, middle fingers on the sphenoid bones, ring fingers on the mastoid and the 5th fingers on the occipital bone). Diagnosis and treatment of restrictions palpated on the scalp will be made using this hand position | Other | Procedure |
Primary outcome
Change in Concussive Symptoms on the Post Concussion Symptom Scale
Time frame: 2 months
The Post Concussion Symptom Scale (PCSS) is a scale used to subjectively measure concussion symptoms. The minimum score is 0 and the maximum score is 132 (a maximum score of 6 for 22 items). The higher the value the worse the symptom. Twenty-two possible symptoms are graded and are the following:Headache, Nausea, Vomiting, Balance Problems, Dizziness, Lightheadedness, Fatigue, Trouble falling asleep, Sleeping more than usual, Sleeping less than usual, Drowsiness, Sensitivity to light, Sensitivity to noise, Irritability, Sadness, Nervous/Anxious, Feeling more emotional, Numbness or tingling, Feeling slowed down, Feeling like "in a fog," Difficulty concentrating, Difficulty remembering, and/or Visual problems. Total score can range from 0 to 132. Units of a scale is used.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial Osteopathic Manipulative Medicine in people with Concussion Injury of Cerebrum and Cranial Osteopathic Medicine, run by Northwell Health.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Concussive Symptoms on the Post Concussion Symptom Scale (time frame: 2 months). 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 25 Jun 2019.