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Abstract
Objective To determine whether Scrambler therapy is an effective, acceptable, and feasible treatment of persistent central neuropathic pain in patients with neuromyelitis optica spectrum disorder (NMOSD) and to explore the effect of Scrambler therapy on co-occurring symptoms.
Methods We conducted a randomized single-blind, sham-controlled trial in patients with NMOSD who have central neuropathic pain using Scrambler therapy for 10 consecutive weekdays. Pain severity, pain interference, anxiety, depression, and sleep disturbance were assessed at baseline, at the end of treatment, and at the 30- and 60-day follow-up.
Results Twenty-two patients (11 per arm) were enrolled in and completed this trial. The median baseline numeric rating scale (NRS) pain score decreased from 5.0 to 1.5 after 10 days of treatment with Scrambler therapy, whereas the median NRS score did not significantly decrease in the sham arm. Depression was also reduced in the treatment arm, and anxiety was decreased in a subset of patients who responded to treatment. These symptoms were not affected in the sham arm. The safety profiles were similar between groups.
Conclusions Scrambler therapy is an effective, feasible, and safe intervention for central neuropathic pain in patients with NMOSD. Decreasing pain with Scrambler therapy may additionally improve depression and anxiety.
Clinicaltrials.gov identifier NCT03452176.
Classification of evidence This study provides Class II evidence that Scrambler therapy significantly reduces pain in patients with NMOSD and persistent central neuropathic pain.
Glossary
- AE=
- adverse event;
- CI=
- confidence interval;
- FSA=
- Food and Drug Administration;
- Neuro-Qol=
- Quality of Life in Neurological Disorders;
- NMOSD=
- neuromyelitis optica spectrum disorder;
- NRS=
- numeric rating scale;
- QoL=
- quality of life;
- SAE=
- serious AE;
- TENS=
- transcutaneous electric nerve stimulation
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Class of Evidence: NPub.org/coe
Podcast: NPub.org/gi1twt
- Received April 4, 2019.
- Accepted in final form November 13, 2019.
- © 2020 American Academy of Neurology
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