Ultrasound-Guided Stellate Ganglion Block for the Treatment of Chronic Migraine in Adults: Study Protocol for a Randomized, Open-Label, Blinded Endpoint Trial.

Abstract

Background: Chronic migraine (CM) is a recurring disorder with a relatively poor prognosis. Microinvasive and nonpharmacological therapies are essential for refractory patients with this condition. To date, only nonrandomized trials have reported the efficacy of the stellate ganglion block (SGB) for CM patients. Whether a combination of SGB and drug therapy is an optimal treatment for CM patients must still be confirmed with randomized controlled studies utilizing standardized oral medications as a control.

Objective: To assess the efficacy and safety of the repeated administration of SGBs over a 4-week period on the basis of standardized oral medications for reducing the severity and number of migraine episodes during the course of a 6-month trial in CM patients for whom prophylactic treatment has failed. The aim of this study was to provide more effective nonpharmacological therapies.

Study design: A prospective, randomized, open-label, blinded endpoint trial.

Setting: A pain clinic in Beijing, China.

Methods: CM patients from 18 to 65 years of age will be enrolled. Patients unresponsive to migraine prophylaxis will be randomly assigned to receive either SGB with standardized drug therapy (SGB group) or standardized drug therapy alone (drug group) in an effort to determine the efficacy of SGBs for the treatment of CM.

Results: The efficacy and safety of the SGB as a CM treatment will be compared to those of the SGB in combination with drug therapy. Differences in pain relief and functional improvement will be assessed. The primary outcome is the change in mean monthly (defined as a 4-week time span) migraine days during the 6-month follow-up period following the patients' first SGB treatment. Secondly, analgesic medication requirements, quality-of-life assessments, and any SGB complications will also be addressed during the 6-month follow-up period.

Limitations: Neither the investigators nor the patients were blinded to treatment allocation. Additionally, this is a short-term follow-up study.

Conclusions: This study is a randomized controlled trial with a relatively large sample size to demonstrate the potential benefits of combined SGBs and drug therapy for CM patients. In the short term, this combined therapy will likely optimize CM treatment management. Further research will be needed to assess the efficacy of this treatment as a long-term therapeutic option.