Clinical trial NCT03588364: The Role of Osteopathic Manipulation in the the Management of Post-traumatic Migraine
Official title: The Role of Osteopathic Manipulation in the the Management of Post-traumatic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Disorders
Post-Traumatic Headache
Keywords: osteopathic manipulation
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Headache Frequency Log
timeFrame: 6 weeks
Secondary outcomes:
measure: Migraine Disability Assessment Score (MIDAS)
timeFrame: 6 weeks
measure: Center for Epidemiological Studies-Depression (CES-D)
timeFrame: 6 weeks
measure: 36-Item Short Form Survey Instrument (MOS-SF-36)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Hollis H King, DO, PhD
role: PRINCIPAL_INVESTIGATOR
References: