Loading clinical trials...
Loading clinical trials...
Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias: a Multicentric, Controlled, Randomized Study
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.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
April 20, 2018
Primary Completion Date
June 26, 2021
Completion Date
September 3, 2021
Last Updated
October 11, 2021
22
ACTUAL participants
Occipital nerve stimulation
DEVICE
Optimal Medical Management
OTHER
Lead Sponsor
Nantes University Hospital
NCT06937385
NCT06458179
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06247592