Migraine DisordersOMT/mTBINCT03588364
The Role of Osteopathic Manipulation in the the Management of Post-traumatic Migraine
A study testing Osteopathic Manipulation in people with Migraine Disorders and Post-Traumatic Headache, run by University of California, San Diego at 1 site in United States.
Trial summary
This study evaluates the use of osteopathic manipulation (manual medicine) for migraine headache following traumatic head injury. Headache is an important and very common somatic complaint among people with traumatic brain injury and an important cause of disability in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Disorders, Post-Traumatic Headache
- What is being tested?
- Osteopathic Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2016to Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of TBI, concussion, post-concussive syndrome
- Headache frequency >/equal 4 per month
- Post-traumatic headache, migraine type
- MIDAS Grade I-IV
- Headaches continue to occur 3 months to 1 year after the injury
- No history of uncontrolled migraine prior to head injury
Who cannot join
- Headache medication change (Tricyclic antidepressant, antiepileptic medication, propranolol, verapamil, duloxetine, butterbur, Botox) within 30 days
- Non-pharmacologic headache management change (reduction in caffeine intake, reduction in alcohol intake, sleep hygiene, exercise) within 30 days
- Less than 3 months from injury
- History of uncontrolled migraine prior to TBI
- Currently taking oral anti-coagulants
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
This study evaluates the use of osteopathic manipulation (manual medicine) for migraine headache following traumatic head injury. Headache is an important and very common somatic complaint among people with traumatic brain injury and an important cause of disability in the United States. Over 15-percent of soldiers deployed to Iraq sustained concussion. A majority of these patients suffer from headaches. Many of these are classified as migraine headache that do not respond to medications. Osteopathic manipulation is practiced by physicians in the United States and has been shown to be beneficial in some migraine patients. However, its use in the management of persistent post-traumatic headaches has not been explored. The investigators will use a randomized cross-over design to evaluate post-traumatic migraine patients' response to osteopathic manipulation.
Read the detailed description
This is a 30-week prospective, randomized delayed treatment control group design in which 20 participants from the community will be randomized 1:1 into (a) an immediate treatment group that will receive 12 weeks of osteopathic manipulation (OMT) treatment plus standard of care right away or (b) delayed treatment group that will receive 12 weeks of OMT plus standard of care after a 6-week waiting period. The delayed treatment group initially serves as a control condition but then receives the experimental treatment. The investigators selected this control condition to improve our statistical power in this small pilot study. As noted, all participants will continue to receive standard of care throughout the study as a washout is not feasible with osteopathic manipulation and removing standard of care could exacerbate the participant's symptoms. Participants in both arms will be followed for another 12 weeks after the 12 weeks of OMT, resulting in 24 weeks of study participation for the immediate treatment group and 30 weeks of study participation for the delayed treatment group, with participants in both arms answering a series of questionnaires to evaluate migraine frequency and impact, treatment efficacy, side effects, adherence t standard of care and depressive symptoms every 6 weeks throughout their study participation. Participant encounters will consist of screening, psychometric and functional scale administration at every 6 weeks for a total of 24-30 weeks, as well as 12 weeks of OMT treatments for participants in both study arms. Study participants will likely come from UCSD internal referrals.
- Conditions
- Migraine Disorders, Post-Traumatic Headache
- Being tested
- Osteopathic Manipulation
- Keywords
- osteopathic manipulation
- Medical subject headings
- Migraine Disorders, Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic ManipulationOther
Osteopathic manipulation involves a number of different manual techniques. These include muscle inhibition; myofascial release; muscle energy stretch; counterstrain; facilitated positional release ; osteopathy in the cranial field ; balanced ligamentous tension/ligamentous articular strain; one or all of these techniques may be used. Participants will be positioned on an exam table supine, seated, lateral decubitus, prone, or in their position of greatest comfort for the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulation | Experimental | Twelve weekly sessions using the techniques of osteopathy in the cranial field. Receives: Other: Osteopathic Manipulation |
| Waitlist Control | No intervention | Six-week waiting period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Frequency Log
Participants will complete a form indicating the frequency, location, duration, characteristics, and associated features of their headache.
Measured: 6 weeks
Secondary outcomes (3)
Migraine Disability Assessment Score (MIDAS)
Scale measures migraine disability by asking participants to indicate number of various events missed (or completed with reduced productivity) over the past three months; as well as average pain associated with headaches in the past 3 months.
Measured: 6 weeks
Center for Epidemiological Studies-Depression (CES-D)
20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Measured: 6 weeks
36-Item Short Form Survey Instrument (MOS-SF-36)
36-item, patient-reported survey of health-related quality of life. Each of the eight scales is transformed into a 0-100 scale. The 8 scales include: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start15 Sep 2016
- Primary completionDec 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- This is a 30-week prospective, randomized delayed treatment control group design in which 20 participants from the community will be randomized 1:1 into (a) an immediate treatment group that will receive 12 weeks of osteopathic manipulation (OMT) treatment plus standard of care right away or (b) delayed treatment group that will receive 12 weeks of OMT plus standard of care after a 6-week waiting period. The delayed treatment group initially serves as a control condition but then receives the experimental treatment.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollis King, University of California, San Diego
- Investigators
- Hollis H King, DO, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588364
- Sponsor's protocol ID
- OMT/mTBI
- Acronym
- OMT/mTBI
- Status last verified
- Jun 2019
- First submitted
- 4 Jul 2018
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Osteopathic Manipulation in the the Management of Post-traumatic Migraine
- ClinicalTrials.gov ID
- NCT03588364
- Acronym / sponsor ID
- OMT/mTBI / OMT/mTBI
- Conditions
- Migraine Disorders, Post-Traumatic Headache
- Keywords
- osteopathic manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 17 Jul 2018 (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.
This study evaluates the use of osteopathic manipulation (manual medicine) for migraine headache following traumatic head injury. Headache is an important and very common somatic complaint among people with traumatic brain injury and an important cause of disability in the United States. Over 15-percent of soldiers deployed to Iraq sustained concussion. A majority of these patients suffer from headaches. Many of these are classified as migraine headache that do not respond to medications. Osteopathic manipulation is practiced by physicians in the United States and has been shown to be beneficial in some migraine patients. However, its use in the management of persistent post-traumatic headaches has not been explored. The investigators will use a randomized cross-over design to evaluate post-traumatic migraine patients' response to osteopathic manipulation.
Detailed description
This is a 30-week prospective, randomized delayed treatment control group design in which 20 participants from the community will be randomized 1:1 into (a) an immediate treatment group that will receive 12 weeks of osteopathic manipulation (OMT) treatment plus standard of care right away or (b) delayed treatment group that will receive 12 weeks of OMT plus standard of care after a 6-week waiting period. The delayed treatment group initially serves as a control condition but then receives the experimental treatment. The investigators selected this control condition to improve our statistical power in this small pilot study. As noted, all participants will continue to receive standard of care throughout the study as a washout is not feasible with osteopathic manipulation and removing standard of care could exacerbate the participant's symptoms. Participants in both arms will be followed for another 12 weeks after the 12 weeks of OMT, resulting in 24 weeks of study participation for the immediate treatment group and 30 weeks of study participation for the delayed treatment group, with participants in both arms answering a series of questionnaires to evaluate migraine frequency and impact, treatment efficacy, side effects, adherence t standard of care and depressive symptoms every 6 weeks throughout their study participation. Participant encounters will consist of screening, psychometric and functional scale administration at every 6 weeks for a total of 24-30 weeks, as well as 12 weeks of OMT treatments for participants in both study arms. Study participants will likely come from UCSD internal referrals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a 30-week prospective, randomized delayed treatment control group design in which 20 participants from the community will be randomized 1:1 into (a) an immediate treatment group that will receive 12 weeks of osteopathic manipulation (OMT) treatment plus standard of care right away or (b) delayed treatment group that will receive 12 weeks of OMT plus standard of care after a 6-week waiting period. The delayed treatment group initially serves as a control condition but then receives the experimental treatment.
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulation | Experimental | Other: Osteopathic ManipulationTwelve weekly sessions using the techniques of osteopathy in the cranial field. |
| Waitlist Control | No intervention | –Six-week waiting period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- History of TBI, concussion, post-concussive syndrome
- Headache frequency >/equal 4 per month
- Post-traumatic headache, migraine type
- MIDAS Grade I-IV
- Headaches continue to occur 3 months to 1 year after the injury
Key exclusion criteria (5 listed)
- Headache medication change (Tricyclic antidepressant, antiepileptic medication, propranolol, verapamil, duloxetine, butterbur, Botox) within 30 days
- Non-pharmacologic headache management change (reduction in caffeine intake, reduction in alcohol intake, sleep hygiene, exercise) within 30 days
- Less than 3 months from injury
- History of uncontrolled migraine prior to TBI
- Currently taking oral anti-coagulants
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 ManipulationOsteopathic manipulation involves a number of different manual techniques. These include muscle inhibition; myofascial release; muscle energy stretch; counterstrain; facilitated positional release ; osteopathy in the cranial field ; balanced ligamentous tension/ligamentous articular strain; one or all of these techniques may be used. Participants will be positioned on an exam table supine, seated, lateral decubitus, prone, or in their position of greatest comfort for the procedure. | Other | Osteopathic Manipulation |
Primary outcome
Headache Frequency Log
Time frame: 6 weeks
Participants will complete a form indicating the frequency, location, duration, characteristics, and associated features of their headache.
3 secondary outcomes
Migraine Disability Assessment Score (MIDAS)
Time frame: 6 weeks
Center for Epidemiological Studies-Depression (CES-D)
Time frame: 6 weeks
36-Item Short Form Survey Instrument (MOS-SF-36)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Hollis H King, DO, PhD principal investigator
University of California, San Diego
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 Manipulation in people with Migraine Disorders and Post-Traumatic Headache, run by University of California, San Diego 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 6 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: finished, as of the sponsor's last update on 12 Jun 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Headache Frequency Log (time frame: 6 weeks). 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 12 Jun 2019.