Kinetic Oscillation Stimulation as Treatment of Acute Migraine: A Randomized, Controlled Pilot Study

Objective To assess the relief of migraine pain, especially in the acute phase, by comparing active treatment, ie, kinetic oscillation stimulation (KOS) in the nasal cavity, with placebo. Background Exploratory trials testing the efficacy of KOS on migraine patients indicated that this treatment cou...

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Bibliographic Details
Published in:Headache 2015-01, Vol.55 (1), p.117-127
Main Authors: Juto, Jan-Erik, Hallin, Rolf G.
Format: Article
Language:English
Subjects:
Acute Disease
Adult
Analysis of Variance
autonomic nervous system
Autonomic Nervous System - physiology
Biophysics
Confidence intervals
Double-Blind Method
Female
Follow-Up Studies
Humans
kinetic oscillation stimulation
Male
medical device
Medicin och hälsovetenskap
Middle Aged
Migraine
Migraine Disorders - therapy
minimally invasive
neuromodulation
Pain
Pain Measurement
Pilot Projects
Research Submissions
Severity of Illness Index
Time Factors
Treatment Outcome
Vibration - therapeutic use
Young Adult
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Summary:Objective To assess the relief of migraine pain, especially in the acute phase, by comparing active treatment, ie, kinetic oscillation stimulation (KOS) in the nasal cavity, with placebo. Background Exploratory trials testing the efficacy of KOS on migraine patients indicated that this treatment could be a fast‐acting remedy for acute migraine pain. Method Thirty‐six patients were randomized 1:1 using a placebo module to active or placebo treatment in this double‐blinded parallel design study. Treatment was administered with a minimally invasive inflatable tip oscillating catheter. Symptom scores (0–10 visual analog scale) were obtained before treatment, every 5 minutes during treatment, at 15 minutes, 2, and 24 hours post‐treatment, as well as daily (0–3 migraine pain scale) from 30 days pretreatment until Day 60 post. Thirty‐five patients were evaluated (active n = 18, placebo n = 17). The primary end‐point was the change in average pain score from before treatment to 15 minutes after treatment. Results Patients who received active treatment reported reduced pain, eg, average visual analog scale pain scores fell from 5.5 before treatment to 1.2 15 minutes after, while the corresponding scores for recipients of placebo fell from 4.9 to 3.9. The changes in pain scores differed between the 2 treatments by 3.3 points (95% confidence interval: 2.3, 4.4), P 
ISSN:0017-8748
1526-4610
1526-4610
DOI:10.1111/head.12485