Trial results for a study investigating remote electrical neuromodulation for acute procedural pain in Chronic Migraine patients were posted on 2025-10-27. The terminated study, which enrolled 80 participants, reported varied mean changes in pain intensity measured by a Visual Analog Scale (VAS).
Background
Chronic migraine is a debilitating neurological condition characterized by frequent headache days. A common preventive treatment involves onabotulinumtoxinA (Botox) injections, which can themselves be associated with acute procedural pain. The development of non-pharmacological methods to alleviate this injection-related pain is an area of ongoing interest. Remote electrical neuromodulation, utilizing devices like Nerivio®, offers a potential approach to manage acute pain through nerve stimulation.
Trial design
This terminated study, which did not specify a phase, enrolled 80 participants diagnosed with Chronic Migraine. The trial's purpose was to assess the effectiveness of using remote electrical neuromodulation, specifically the Nerivio® device, to relieve pain associated with receiving onabotulinumtoxinA (Botox) injections for chronic migraine prevention. Participants received either electrical neuromodulation followed by a sham procedure, or a sham procedure followed by electrical neuromodulation, in a crossover design.
Key results
The trial reported multiple measurements for the change in pain intensity, as assessed by a Visual Analog Scale (VAS) score:
- For the group receiving Electrical Neuromodulation, Then Sham, the mean change in pain intensity was 23.0 (Standard Deviation: 26.3 score on a scale).
- For the group receiving Sham, Then Electrical Neuromodulation, the mean change in pain intensity was 32.9 (Standard Deviation: 24.8 score on a scale).
- For the group receiving Electrical Neuromodulation, Then Sham, the mean change in pain intensity was 52.5 (Standard Deviation: 19.6 score on a scale).
- For the group receiving Sham, Then Electrical Neuromodulation, the mean change in pain intensity was 58.3 (Standard Deviation: 24.2 score on a scale).
- For the group receiving Electrical Neuromodulation, Then Sham, the mean change in pain intensity was 59.9 (Standard Deviation: 22.1 score on a scale).
- For the group receiving Sham, Then Electrical Neuromodulation, the mean change in pain intensity was 62.0 (Standard Deviation: 25.2 score on a scale).
- For the group receiving Electrical Neuromodulation, Then Sham, the mean change in pain intensity was 21.2 (Standard Deviation: 23.3 score on a scale).
- For the group receiving Sham, Then Electrical Neuromodulation, the mean change in pain intensity was 27.0 (Standard Deviation: 23.7 score on a scale).
- For the group receiving Electrical Neuromodulation, Then Sham, the mean change in pain intensity was 37.2 (Standard Deviation: 19.3 score on a scale).
- For the group receiving Sham, Then Electrical Neuromodulation, the mean change in pain intensity was 60.7 (Standard Deviation: 20.6 score on a scale).
- For the group receiving Electrical Neuromodulation, Then Sham, the mean change in pain intensity was 38.7 (Standard Deviation: 19.7 score on a scale).
- For the group receiving Sham, Then Electrical Neuromodulation, the mean change in pain intensity was 64.7 (Standard Deviation: 21.5 score on a scale).
What this means
The posted results from this terminated study provide data on the change in pain intensity experienced by patients with chronic migraine undergoing onabotulinumtoxinA injections, when using remote electrical neuromodulation or a sham procedure. The varied mean VAS changes across the different measurement points and treatment sequences suggest complex responses to the intervention and the sham. The termination of the study indicates that further investigation or a different trial design may be necessary to fully understand the efficacy and role of remote electrical neuromodulation for acute procedural pain in this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05730556, titled "A Study of Remote Electrical Neuromodulation for Acute Procedural Pain", were posted on 2025-10-27 on clinicaltrials.gov.