Review ArticleOccipital Nerve Stimulation in Fibromyalgia: A Double-Blind Placebo-Controlled Pilot Study With a Six-Month Follow-Up
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
REFERENCES (34)
- et al.
Dysfunctional beliefs, stress and sleep disturbance in fibromyalgia
Sleep Med
(2008) - et al.
Prevalence of fibromyalgia: a survey in five European countries
Semin Arthritis Rheum
(2010) - et al.
Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial
Pain
(2008) “Attention” to pain in persons with chronic pain: a behavioural approach
Behav Ther
(1997)- et al.
Ectopic sensory discharges and paresthesiae in patients with disorders of peripheral nerves, dorsal roots and dorsal columns
Pain
(1984) - et al.
Occipital afferent activation of second order neurons in the trigeminocervical complex in rat
Neurosci Lett
(2006) - et al.
The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee
Arthritis Rheum
(1990) Management of fibromyalgia and comorbid psychiatric disorders
J Clin Psychiatry
(2008)- et al.
An internet survey of 2,596 people with fibromyalgia
BMC Musculoskelet Disord
(2007) - et al.
The prevalence and characteristics of fibromyalgia in the general population
Arthritis Rheum
(1995)
Characteristics and patterns of healthcare utilization of patients with fibromyalgia in general practitioner settings in Germany
Curr Med Res Opin
Health services costs and their determinants in women with fibromyalgia
J Rheumatol
Large differences in cost of illness and wellbeing between patients with fibromyalgia, chronic low back pain, or ankylosing spondylitis
Ann Rheum Dis
EULAR evidence-based recommendations for the management of fibromyalgia syndrome
Ann Rheum Dis
Management of fibromyalgia syndrome
JAMA
Multidisciplinary treatment for chronic pain: a systematic review of interventions and outcomes
Rheumatology (Oxford)
Exercise for fibromyalgia: a systematic review
J Rheumatol
Cited by (24)
What's New in Peripheral Nerve Stimulation
2022, Neurosurgery Clinics of North AmericaOccipital Nerve Stimulation
2022, Peripheral Nerve Stimulation: A Comprehensive GuideOccipital Nerve Stimulation
2019, Neurosurgery Clinics of North America
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).