Quantitative and Qualitative Pain Evaluation in Response to OnabotulinumtoxinA for Chronic Migraine: An Observational Real-Life Study

Abstract

(1) Background: Randomized controlled trials and real-life studies demonstrated the efficacy of OnabotulinumtoxinA (OBT-A) for CM prevention. However, no studies specifically addressed its effect on pain’s quantitative intensity and qualitative characteristics. (2) Methods: This is an ambispective study: a post-hoc retrospective analysis of real-life prospectively collected data from two Italian headache centers on CM patients treated with OBT-A over one year (i.e., Cy1-4). The primary endpoint was the changes in pain intensity (Numeric Rating Scale, NRS; the Present Pain Intensity (PPI) scale, the 6-point Behavioral Rating Scale (BRS-6)) and quality scale (the short-form McGill Pain Questionnaire (SF-MPQ)) scores. We also assessed the relationship between changes in intensity and quality of pain and disability scale (MIDAS; HIT-6) scores, monthly headache days (MHDs), and monthly acute medication intake (MAMI) (3) Results: We retrieved 152 cases (51.5 years SD 11.3, 80.3% females). From baseline to Cy-4, MHDs, MAMI, NRS, PPI, and BRS-6 scores decreased (consistently p < 0.001). Only the throbbing (p = 0.004), splitting (p = 0.018), and sickening (p = 0.017) qualities of pain collected in the SF-MPQ were reduced. Score variations in MIDAS related to those in PPI scales (p = 0.035), in the BRS-6 (p = 0.001), and in the NRS (p = 0.003). Similarly, HIT-6 score changes related to PPI score modifications (p = 0.027), in BRS-6 (p = 0.001) and NRS (p = 0.006). Conversely, MAMI variation was not associated with qualitative or quantitative pain score modifications except BRS-6 (p = 0.018). (4) Conclusions: Our study shows that OBT-A alleviates migraine by reducing its impact on multiple aspects, such as frequency, disability, and pain intensity. The beneficial effect on pain intensity seems specific to pain characteristics related to C-fiber transmission and is associated with a reduction in migraine-related disability.

Reducing the Impact of Headache and Allodynia Score in Chronic Migraine: An Exploratory Analysis from the Real-World Effectiveness of Anti-CGRP Monoclonal Antibodies Compared to Onabotulinum Toxin A (RAMO) Study

“…The BoNT-A group showed a smaller reduction of HIT-6 score at 6 and 12 months compared to anti-CGRP mAbs, which, however, was at the limit of clinical relevance. Our data conflicts with other experiences in the literature that showed a slightly superior mean reduction of HIT-6, being at least 5 points or even more [ 38 , 39 ].…”

The effectiveness and predictors influencing the outcome of onabotulinumtoxinA treatment in chronic migraine: understanding from diverse patient profiles in a single session

“…Furthermore, due to the connection between the decrease in headache intensity and disability scales, conducting a thorough headache assessment with patient-reported outcome measures (PROMs), beyond tracking headache days, is advised for a more accurate evaluation of treatment response in chronic migraine. However, only some real-world studies have specifically examined the impact of onabotulinumtoxinA on the qualitative aspects of headache pain in treated individuals (28)(29)(30).…”

Real-world experience of OnabotulinumtoxinA treatment in female patients with chronic migraine: a qualitative study using in-depth interviews

“…They have also shown that treatment with OBT-A decreases disability and improves patients’ quality of life, as measured by standardized scales [ 20 ]. However, for pain syndromes (such as migraine), other non-quantifiable aspects must be considered [ 23 ].…”