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Occipital Nerve Stimulation in Fibromyalgia: A Double-Blind Placebo-Controlled Pilot Study With a Six-Month Follow-Up

Authors

  • Mark Plazier MD,

    Corresponding author
    1. Department of Translational Neuroscience, Faculty of Health science and Medicine University Antwerp, Antwerp, Belgium
    2. Department of Neurosurgery, University Hospital Antwerp, Antwerp, Belgium
    • Address correspondence to: Mark Plazier, MD, Department of Neurosurgery, University Hospital Antwerp (UZA), Wilrijkstraat 10, 2650 Edegem, Antwerp, Belgium. Email: mark.plazier@uza.be

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  • Ingrid Dekelver MD,

    1. Department of Physical Medicine and Rehabilitation, University Hospital Antwerp, Antwerp, Belgium
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  • Sven Vanneste MSc, MA, PhD,

    1. Department of Translational Neuroscience, Faculty of Health science and Medicine University Antwerp, Antwerp, Belgium
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  • Gaëtane Stassijns MD, PhD,

    1. Department of Physical Medicine and Rehabilitation, University Hospital Antwerp, Antwerp, Belgium
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  • Tomas Menovsky MD, PhD,

    1. Department of Translational Neuroscience, Faculty of Health science and Medicine University Antwerp, Antwerp, Belgium
    2. Department of Neurosurgery, University Hospital Antwerp, Antwerp, Belgium
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  • Mark Thimineur MD, PhD,

    1. Department of Anaesthesiology, Griffin Hospital, St. Derby, CT, USA
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  • Dirk De Ridder MD, PhD

    1. Department of Surgical Sciences, Section of Neurosurgery, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
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  • For more information on author guidelines, an explanation of our peer review process, and conflict of interest informed consent policies, please go to http://www.wiley.com/bw/submit.asp?ref=1094-7159&site=1
  • Funding: This work was supported by an educational grant from St. Jude Medical Neuromodulation (Plano, TX, USA).
  • Conflict of Interest: Mark Plazier and Dirk De Ridder are involved in paid educational tasks for St. Jude Medical Neuromodulation (Plano, TX, USA). The other authors reported no conflicts of interest.

Abstract

Objective

The goal of this study is to evaluate the effectiveness of occipital nerve stimulation (ONS) as a surgical treatment for fibromyalgia in a placebo-controlled design.

Materials and Methods

Eleven patients were selected based on the American College of Rheumatology-90 criteria and implanted with an occipital nerve trial-lead stimulator. Baseline scores for pain, mood, and fatigue were acquired, and patients were randomized in a ten-week double-blinded crossover design with placebo and effective subsensory threshold stimulation (no paresthesias). After finalizing the trial, nine patients were implanted permanently; evaluation was performed prior to surgery and at six months after surgery for pain, fatigue, and mood of the number of trigger points and overall morbidity.

Results

Significant results were found during the trial for a decrease in pain intensity (39.74%) on visual analogue scale (VAS; p < 0.001) and pain catastrophizing scale (PCS) during effective stimulation. A total of 9/11 patients responded to trial treatment; however, in two patients, this might be a placebo effect, recognizable due to the study design. Six months after permanent implantation, pain intensity remained decreased (44.01%) on VAS (p < 0.05). Besides the VAS, significant changes were noted for PCS, fatigue (modified fatigue impact scale), the number of trigger points, and overall morbidity (fibromyalgia impact questionnaire). There were no serious adverse events.

Conclusions

Our data strongly suggest that ONS is beneficial in the treatment of fibromyalgia. The beneficial effects are stable at six months after permanent implantation. Subsensory threshold stimulation is feasible in designing a placebo-controlled trial.

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