Medically intractable pain caused by occipital neuralgia can be very difficult to control with traditional pain management. Peripheral nerve stimulation which is used in migraines and cluster headache can be an alternative for these patients with occipital neuralgias when medical treatment and traditional pain management have failed (drugs for neuropathic pain, infiltrations, psychobehavioral approaches and multidisciplinary approach in a pain center). Occipital nerve stimulation consists to put a lead subcutaneously in front of the occipital nerve and to connect the lead to a pulse generator. A retrospective study of 60 patients was conducted in Nantes University Hospital. The results were good with the Visual Analog Scale (VAS) decreased from 8.4 preoperatively to 2.85 postoperatively. The medical quantification scale (MQS) was reduced to about 50% (18 preoperatively versus 9.9 postoperatively). Stimulation was quiet stable over time with a mean follow-up of 24 months (range 6 to 72 months). The aim of StimO is to confirm this result through a national controlled randomized multicenter study where occipital nerve stimulation will be compared to the optimal medical management.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Occipital nerve stimulation with percutaneous or surgical lead
Optimal Medical Management according to what is done in routine clinical practice : drug, psychobehavioral approach, acupuncture, sophrology, etc.
CHU de Caen
Caen, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Hôpitaux Civils de Colmar
Colmar, France
CHU Limoges
Limoges, France
Hôpital Pierre Wertheimer
Lyon, France
CHU de Nantes
Nantes, France
CHU de Nice
Nice, France
Hôpital Lariboisière
Paris, France
Hôpital Foch
Paris, France
CHU de Poitiers
Poitiers, France
Efficacy of occipital nerve stimulation
Compare the decrease of pain (evaluated by visual analogic scale) after 6 months of treatment between the 2 groups (ONS / OMM)
Time frame: 6 months
Decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) in the ONS group at 3 months
Evaluate the decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) after 3 months of occipital nerve stimulation in the ONS group
Time frame: 3 months
Decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) in the ONS group at 6 months
Evaluate the decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) after 6 months of occipital nerve stimulation in the ONS group
Time frame: 6 months
Maximum pain (using Visual Analogic Scale)
Comparison of maximum pain (using Visual Analogic Scale) between the 2 groups (ONS/OMM)
Time frame: Up to 6 months
Average pain (using Visual Analogic Scale)
Comparison of average pain (using Visual Analogic Scale) between the 2 groups (ONS/OMM)
Time frame: Up to 6 months
Relative decrease of pain (using Visual Analogic Scale) at 3 months
Comparison of the relative decrease of pain (using Visual Analogic Scale) at 3 months between the 2 groups (ONS/OMM)
Time frame: 3 months
Relative decrease of pain (using Visual Analogic Scale) at 6 months
Comparison of the relative decrease of pain (using Visual Analogic Scale) at 6 months between the 2 groups (ONS/OMM)
Time frame: 6 months
Efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 3 months
Comparison of the efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 3 months between the 2 groups (ONS/OMM)
Time frame: 3 months
Efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 6 months
Comparison of the efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 6 months between the 2 groups (ONS/OMM)
Time frame: 6 months
Quality of life (using EQ-5D-5L questionnaire)
Comparison of the quality of life (using EQ-5D-5L questionnaire) between the 2 groups (ONS/OMM)
Time frame: Up to 6 months
Quality of life (using Hamilton Anxiety and Depression (HAD) scale)
Comparison of the quality of life (using Hamilton Anxiety and Depression (HAD) scale) between the 2 groups (ONS/OMM)
Time frame: Up to 6 months
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