Article
Controlled open single-blinded trial for evaluation of efficacy and safety of occipital nerve stimulation (ONS) for the treatment of medical refractory head- and neck pain
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Authors
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Jan Vesper
- Funktionelle Neurochirurgie und Stereotaxie, Neurochirurgische Klinik, Universitätsklinikum Düsseldorf
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Gregor A. Bara
- Funktionelle Neurochirurgie und Stereotaxie, Neurochirurgische Klinik, Universitätsklinikum Düsseldorf
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Philipp J. Slotty
- Funktionelle Neurochirurgie und Stereotaxie, Neurochirurgische Klinik, Universitätsklinikum Düsseldorf
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Stefan Schu
- Funktionelle Neurochirurgie und Stereotaxie, Neurochirurgische Klinik, Universitätsklinikum Düsseldorf
| Published: | May 21, 2013 |
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Outline
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Objective: Migraine is highly prevalent along with the high percentage of treatment-refractory cases. Primary headache disorders encompass a variety of conditions, and the primary anatomical structures implicated in these conditions also differ. The complicated functional and anatomic relationships resulting in pain and other features of the primary headaches are not limited to the central nervous system, but involve peripheral nervous system structures of the head and neck as well. ONS may provide pain relief for patients with otherwise refractory primary headache disorders. It is more generally applicable than other invasive methods. We investigated ONS in a series of patients to determine efficacy and safety of this method.
Method: We included a case series of 23 patients who had chronic headaches for a duration of 5.3 y who underwent ONS lead implantation (SJM, Octrode). Prior to surgery patients had received conservative and surgical therapies without success. Using a midline approach two octrodes were placed subcutaneously and positioned across the level of C1 using fluoroscopy. Leads were placed under general anaesthesia. Patients were randomized in three single blinded groups (a: blank control, B: sham control – ineffective stimulation, C: effective stimulation). The groups were changed every week. According to the study design the following data were collected: VAS, TFC, SF36, TFC, pain detect program.
Results: Device dislocation was found in 3 cases (15%). All patients underwent implantation of the generator (eon MINI, SJM). The included patients mentioned significant relief of pain after 3 months, so they matched inclusion criteria. The mean VAS score changed from 8.2±1.5 to 3.5±1.3 in the effective group. No significant improvement was observed in group A and B. Functional capacity also significantly improved in group C.
Conclusions: The exact mechanism of neuromodulation in the treatment of different headache syndromes remains unclear. ONS is safe and efficacious in the treatment of medically intractable headaches conditions. Further investigations are required to evaluate predictors for patient selection and stimulation setting among this crucial pain conditions.
