Prospective, Multi-Center Evaluation of the Efficacy of Peripheral Trigger Decompression Surgery for Migraine Headaches

Study Summary

According to the peripheral trigger theory of migraine headaches, nociceptive inputs from irritated or compressed cranial nerve branches can lead to neurovascular changes in the brain that cause migraine headaches. Advanced treatments aimed at deactivating the peripheral trigger points can be administered to patients who have failed medical management of migraines. Those accepted advanced treatments include botulinum toxin A injection in order to temporarily paralyze muscles causing nerve compression, and surgery to release those compression points permanently. An advantage of surgery is the ability to release non-muscular causes of nerve compression, such as fascial bands or intersecting arteries. Botulinum toxin A injection into trigger sites has been shown in multiple studies to be effective at reducing the frequency and severity of migraine headaches, and is a very commonly administered treatment for refractory migraines. It is approved by the FDA for the treatment of chronic migraines. Similarly, surgical decompression of trigger sites has previously been shown to have superior clinical outcomes to medical management, through a randomized, blinded controlled-trial performed at Case Western Reserve in 2009. Patients either received actual decompression of the trigger sites, or sham surgery (exposure and visualization of the trigger sites, without decompression). At one-year follow-up, the group who underwent actual surgery demonstrated a statistically higher proportion with significant improvement in their migraines (83.7% vs. 57.7%, p=0.014), and with complete elimination of their migraines (57.1% vs. 3.8%, p\<0.001). Several other reports have confirmed the good clinical outcomes of surgery demonstrated in this trial, and surgical decompression is now commonly performed by several surgeons around the United States. Prognostic factors predicting the success of surgical decompression in migraine headache treatment include older age of migraine onset, visual s

Primary Outcome

MHI is a numerical value calculated by multiplying the severity (1-10 numerical rating scale), duration (fraction of 24 h), and frequency (days per month) of migraine headaches. The lower the value the lower migraine severity reported is. The index range is minimum 0.00 to maximum 300.00.

Interventions

• PROCEDURE Surgery
• DRUG Botulinum Toxin Type A
• OTHER Daily headache diary
• OTHER Migraine Disability Assessment Test (MIDAS)
• OTHER Migraine Work and Productivity Loss Questionnaire (MWPLQ)