Abstract
Background and Aims
Nociception is the most prevalent pain mechanism in Parkinson disease (PD). It negatively
affects quality of life, and there is currently no evidence-based treatment for its
control. Burst spinal cord stimulation has been used to control neuropathic pain and
recently has been shown to relieve pain of nociceptive origin. In this study, we hypothesize
that burst transspinal magnetic stimulation (bTsMS) reduces nociceptive pain in PD.
Materials and Methods
Twenty-six patients were included in a double-blind, sham-controlled, randomized parallel
trial design, and the analgesic effect of lower-cervical bTsMS was assessed in patients
with nociceptive pain in PD. Five daily induction sessions were followed by maintenance
sessions delivered twice a week for seven weeks. The primary outcome was the number
of responders (≥ 50% reduction of average pain intensity assessed on a numerical rating
scale ranging from 0–10) during the eight weeks of treatment. Mood, quality of life,
global impression of change, and adverse events were assessed throughout the study.
Results
Twenty-six patients (46.2% women) were included in the study. The number of responders
during treatment was significantly higher after active than after sham bTsMS (p = 0.044), mainly owing to the effect of the first week of treatment, when eight patients
(61.5%) responded to active and two (15.4%) responded to sham bTsMS (p = 0.006); the number needed to treat was 2.2 at week 1. Depression symptom scores
were lower after active (4.0 ± 3.1) than after sham bTsMS (8.7 ± 5.3) (p = 0.011). Patients’ global impressions of change were improved after active bTsMS
(70.0%) compared with sham bTsMS (18.2%; p = 0.030). Minor adverse events were reported in both arms throughout treatment sessions.
One major side effect unrelated to treatment occurred in the active arm (death due
to pulmonary embolism). Blinding was effective.
Conclusion
BTsMS provided significant pain relief and improved the global impression of change
in PD in this phase-II trial.
Clinical Trial Registration
The Clinicaltrials.gov registration number for the study is NCT04546529.
Keywords
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Comments
Article info
Publication history
Published online: November 18, 2022
Accepted:
October 3,
2022
Received in revised form:
September 14,
2022
Received:
June 23,
2022
Footnotes
Source(s) of financial support: This study was funded by the Pain Center, HC-FMUSP, CNPq (scientific production scholarship Manoel Jacobsen Teixeira, DCA). The Center for Neuroplasticity and Pain is supported by the Danish National Research Foundation (DNRF121). Daniel Ciampi de Andrade is supported by a Novo Nordisk Grant NNF21OC0072828.
Conflict of Interest: The authors reported no conflict of interest.
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© 2022 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.
