The Comparison of the Effects of Two Botulinum Toxin A Injection Methods, Follow the Pain and Fixed-site Fixed-dose, on Improving the Quality of Life and Headaches in Patients with Chronic Migraine: A Preliminary Randomized Clinical Trial

Hossein Salehi; Mohaddaseh Fekri; Alireza Vakilian; Mohsen Rezaeaian; Hassan Ahmadinia

doi:10.4274/tnd.2020.56767

Hossein Salehi¹, Mohaddaseh Fekri², Alireza Vakilian³, Mohsen Rezaeaian⁴, Hassan Ahmadinia⁵

¹Department of Plastic and Reconstructive Surgery, School of Medicine, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
²Clinical Research Development Center, Ali Ibn Abi Talib Hospital, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
³Department of Neurology, School of Medicine, Non-communicable Diseases Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
⁴Department o Epidemiology and Biostatistics, Occupational Environmental Research Center, Rafsanjan Medical School, Rafsanjan University of Medical Sciences, Rafsanjan, Iran
⁵Department of Epidemiology and Biostatistics, Medical School, Rafsanjan University of Medical Sciences, Rafsanjan, Iran

Keywords: Chronic migraine, botulinum toxin A, quality of life, method of injection

Abstract

Objective: Migraine headaches are one of the most common and debilitating diseases. Chronic migraine (CM) is a type of migraine that reduces quality of life and causes disability. Botulinum toxin A (BT-A) was approved in 2010 by the Food and Drug Administration for CM as one of the treatment options. In BT-A treatment, follow the pain (FTP), fixed-site fixed-dose (FSFD) methods, and combined injections are prevalent. This clinical trial aimed to compare the effects of two methods of BT-A injections in patients with CM to determine the method with the fewest complications, the strongest therapeutic effects, and the lowest costs in improving quality of life.

Materials and Methods: In this preliminary clinical trial, 40 patients with CM were screened, and after examining the inclusion criteria, 18 patients completed the trial. After a baseline examination and experiencing a 28-day baseline period, they were randomly divided into FSFD and FTP groups. In our study, we used the Quality of Life Questionnaire, the Migraine Daily Note, and Headache Impact Test-6.

Results: A total of 17 women and 1 man completed the trial. Severity and rate of headaches and quality of life scores had better changes in the following months with similar trends in both groups without a significant difference.

Conclusion: The comparison of the scores showed an improvement in most patients, but there was no significant difference between the FSFD and FTP groups. However, the results indicated a greater response to the treatment and a higher rate of drug use in the FSFD group.