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  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 [Turk J Neurol]
Turk J Neurol. 2020; 26(4): 269-276 | DOI: 10.4274/tnd.2020.56767  

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 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

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.

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


Hossein Salehi, Mohaddaseh Fekri, Alireza Vakilian, Mohsen Rezaeaian, Hassan Ahmadinia. 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. Turk J Neurol. 2020; 26(4): 269-276

Corresponding Author: Alireza Vakilian, Iran


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