NCT03588364

The Role of Osteopathic Manipulation in the the Management of Post-traumatic Migraine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine Disorders
• Post-Traumatic Headache

Interventions

Type	Name	Description
OTHER	Osteopathic Manipulation	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.

Timeline

• Start date: 2016-09-15
• Primary completion: 2018-12-01
• Completion: 2019-06-01
• First posted: 2018-07-17
• Last updated: 2019-06-12

Locations

1 site across 1 country: United States