Migraine Headache Study at UCSD

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


Did you sustain a head injury in the past 12 months?

Do you suffer from migraine headaches since the injury? 

The International Headache Society defines migraines as:

Headache attacks lasting 4-72 hr (untreated or unsuccessfully treated)

Headache has at least two of the following four characteristics:

1. one-sided location
2. pulsating quality
3. moderate or severe pain intensity
4. aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)

During headache at least one of the following:

1. nausea and/or vomiting
2. Sensitivity to light and/or sound

Study Overview

Dr. Hollis King, DO, PhD and his colleagues are conducting a research study to find out more about how osteopathic manipulation, a form of manual/hands-on treatment affects migraines in people who have sustained head injury. We are looking for individuals ages 18 years or older who have experienced post-traumatic migraines at least 4X/month for a period of 3-12 months.There will be approximately 20 participants in total.
 
The purpose of this study is to determine if osteopathic manipulation, a form of manual medicine, is effective for treating migraines that occur after head trauma.
 
If you are eligible to participate and agree to be in this study, the following will happen to you:
You will continue on any treatment regimen prescribed by your physician, which is standard of care for your migraine headache. You will receive 12 weeks of osteopathic manipulation. This procedure is experimental in this study. The physician providing the experimental treatment will also conduct a physical examination at every visit. Every 12 weeks you will complete a series of questionnaires to evaluate migraine frequency and impact, treatment efficacy, side-effects, adherence to standard of care, and depressive symptoms.  After the treatment is completed you will answer the questionnaires every 6 weeks for 12 weeks.
 
Osteopathic manipulation involves a number of different manual (hands-on) techniques. These include muscle inhibition (applying pressure to a muscle to induce relaxation); myofascial release (applying pressure to the fascia and moving it toward/away from a strain); muscle energy stretch (contraction of a stretching muscle); counterstrain (shortening a strained muscle); facilitated positional release (moving a vertebra into a restriction and applying a gentle compression); osteopathy in the cranial field (balancing the cranial tissue); balanced ligamentous tension/ligamentous articular strain (moving a joint into ease to release tension in the ligament); one or all of these techniques may be used. You will be positioned on an exam table on your back, seated, on your side, on your stomach, or in the most comfortable position for you. Treatment is expected to take 45 minutes.
 
You will be assigned by chance to a study group. Your chance of being assigned to each group is 50%. Neither you nor the researcher(s) can choose the group to which you will be assigned. 
 
Group one will start experimental treatment with osteopathic manipulation immediately for 12 weeks and have a follow-up period of 12 weeks. You will continue to receive your regularly physician prescribed headache regimen for your migraine, which is standard of care.  
 
Group 2 will have a delay of 6 weeks before starting the experimental treatment and the 12 week follow-up period. During this period those participants symptoms will be monitored. You will continue to receive your regularly physician prescribed headache regimen for your migraine, which is standard of care.  Standard of care is not a requirement for participation in this study and is left at the discretion of your private physician.
 
You will be asked not to change your current headache management for the course of the study.
 
Study questionnaires are estimated to take 20 minutes to complete. They will occur at 6 week intervals while undergoing treatment and for 12 weeks following. If assigned to the delayed treatment group, you will be monitored for 12 weeks before starting treatment and will complete the questionnaires at 6 week intervals during that period. Treatment will consist of hour long visits weekly for 12 weeks. The total duration of the study is 36 weeks. You will be asked to keep a log of your headaches.
 
There will be no cost to you for participating in this study.  The 12 weeks of osteopathic manipulation treatment will be provided free of charge.

If you are interested please contact: Meredith Pung, Research Coordinator at (858) 534-3495