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

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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.

Section snippets

INTRODUCTION

Fibromyalgia is characterized by widespread musculoskeletal pain. The diagnostic criteria, proposed by the American College of Rheumatology (ACR), comprise of a history of widespread pain, affecting all four quadrants of the body, lasting for minimally three months. Furthermore, 11 out of 18 designated tender points should elicit pain when applying 4 kg of pressure (1). Pain is often accompanied by sleep disorders, fatigue, and headache, as well as psychological problems (2., 3., 4.).

The

Selection of Patients

Patients suffering from fibromyalgia were selected by the Department of Physical Medicine and Rehabilitation at the University Hospital Antwerp, Belgium according to the criteria of the ACR-90 (1). Patients harboring pathologies mimicking the symptoms of fibromyalgia, as well as patients suffering from severe organic or psychiatric comorbidity (except minor depressive disorder), were excluded from participation. None of the patients were suffering from cervicotrigeminal tract radicular symptoms

Crossover Trial

All 11 patients completed the ten-week trial period. Data for one week (placebo stimulation) of one patient (case 10) were excluded as this patient was suffering from influenza, which may have interfered with the results.

DISCUSSION

Our results provide evidence that 1) ONS is beneficial in the treatment of fibromyalgia in a placebo-controlled manner: VAS and PCS decreased significantly; 2) ONS exerts beneficial effects on pain (VAS, PCS, TP), fatigue (mFIS), and overall fibromyalgia-related symptoms (FIQ) six months after implantation; 3) subsensory threshold stimulation in ONS is feasible to provide placebo-controlled results.

CONCLUSION

Although the mechanism of action of ONS on fibromyalgia is still unclear, the data presented demonstrate a placebo-controlled beneficial effect on pain in fibromyalgia, which is confirmed after permanent implantation at six months follow-up. Besides local inflammation at the externalization site of the electrode, no serious adverse events occurred.

Acknowledgements

The authors would like to thank Lotte Reps for revising the English style and grammar and Jan Ost for providing the drawing.

Authorship Statement

Mark Plazier: patient selection, surgery, data collection, design study, preparing manuscript

Ingrid Dekelver: patient selection, data collection

Sven Vanneste: design study, preparing manuscript

Gaëtane Stassijns: patient selection, data collection

Tomas Menovsky: surgery, preparing manuscript

Mark Thimineur: study design, preparing manuscript

Dirk De Ridder: surgery, design

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    Funding: This work was supported by an educational grant from St. Jude Medical Neuromodulation (Plano, TX, USA).

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