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395 PERCENTAGE OF SUCCESSFUL TRIAL WITH PRECISION™ SPINAL CORD STIMULATION IN FAILED BACK SYNDROME
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Posters / European Journal of Pain Supplements 4 (2010) 47–146
pain, we hypothesize to discriminate patients with somatoform pain disorder from healthy controls automatically on a single subject level. Methods: We investigated 13 female patients and 13 gender and age matched healthy controls. During fMRI scanning, we applied a series of alternating noxious and innocuous tonic heat stimuli on the inner side of the left forearm. We used the whole fMRI data time-series including noxious, innocuous, resting conditions for classification analysis. We extracted and scaled the time series of the mean fMRI BOLD signal of 90 defined AAL ROIs with the SPM2 Marsbar Toolbox and concatenated the time-series of all ROIs separately for every subject. The CLASSIF1 software was used for classification (Valet, 993). 10 patients and 10 controls were randomly selected as learning data set; 3 patients and 3 controls were used as test data set (hold-out validation). Results: The accuracy result of classification was 92.3% (1 misclassification, each in the learn and test data set). Relevant discriminating differences of fMRI-BOLD signals between patients and controls were found in memory relevant brain structures, such as Amygdala, Fusiform Cortex, Parahippocampus, as well as the Temporal Cortex. The results match with findings from our recent fMRI study investigating task related changes to noxious stimulation in this patient group (Gundel, ¨ 2008). Conclusions: The CLASSIF1-algorithm as a hypothesis free data analysis approach generates accurate classification results for the individualized discrimination of patients from controls. 393 LONG TERM FOLLOW-UP AFTER CONTINUOUS INTRATHECAL BACLOFEN THERAPY FOR SEVERE SPASTICITY E. Anastasiou1 , A. Tzortzopoulou1,2 , A. Alexandropoulou1 , K. Rizos2 , A. Karakosta1 , A. Kolotoura1 . 1 Anaesthesiology & Pain Clinic, 2 Neurosurgery, ‘Thriassio’ General Hospital of Elefsina, Magoula – Elefsina, Greece Introduction: Baclofen is an agonist of GABA-B receptor which presynaptically inhibits the nerve terminal. Intrathecal baclofen administration via an implantable pump placed subcutaneously in the lateral abdominal area has evolved into a standard treatment for intractable spasticity regardless of origin. Objectives: The purpose of this study was to determine the efficacy and safety of intrathecal baclofen therapy for severe spasticity delivered by a constant flow implantable pump. Methods: A long term observational follow-up study evaluating 30 patients who received intrathecal baclofen via a pump (22 cases with spinal cord related spasticity and 8 cases with cerebral spasticity). The mean follow-up period was 52 months. The initial Ashworth score was 3.7. The average dosage of baclofen was 280 mcg/day. At each follow up visit, clinical efficacy of constant drug administration on spasticity was evaluated by applying Ashworth score. All adverse events and complications were recorded. Results: All but one of the patients responded satisfactorily to therapy. Ashworth score declined from 3.7 to 1.9. Hypotonia and somnolence were the most frequent adverse symptoms. Complications were rare. Technical incidents related to the catheter occurred in 2 patients (6.66%). One patient (3.33%) had cerebrospinal fluid leakage. No infections were reported. In the vast majority of cases there was a remarkable reduction in spasticity and there was an improvement in the psychosocial status of the patients. Conclusions: Continuous intrathecal baclofen infusion for severe refractory spasticity is a reversible procedure providing for appropriately selected patients qualitative and quantitative improvements in quality of life.
394 ARE PERIPHERAL NERVE EVALUATION TRIALS A SAFE AND EFFECTIVE METHOD OF ASSESSING SUITABILITY FOR A SACRO-NEUROMODULATION IMPLANT FOR PELVIC PAIN? J. Cambitzi, A. Baranowski. Pain Management Centre, University College London, London, UK Introduction: Sacral neuromodulation (SNM) is a widely accepted treatment modality for bladder and bowel dysfunction. The therapy has been proven effective and safe and is supported by guidelines. However the use of SNM for the treatment of Chronic Pelvic Pain (CPP) is relatively new. Objectives: This prospective audit aimed to establish whether a relatively inexpensive Peripheral Nerve Evaluation (PNE) trail is a safe and effective method to test the suitability of a patient for implantation of a permanent and expensive SNM device. Methods: SNM of S3 or S4 nerves was obtained by using a transforamenal approach with un-tined lead inserted under x-ray guidance, with patients awake thus optimising placement. The patients were discharged home with external wires; stimulation was achieved using a test stimulator device, manipulated by the patients. Data were collected from patients, on day 3 utilising a pain diary, when wires were removed. Results: 33 patients were considered from the Urogenital pain clinic to received PNE between July 2007–July 2009. 6 patients chose not to enter trail. Out of 27 that received a PNE, 13 achieved therapeutic stimulation, which is defined as a >30% reduction in pain. 10 are proceeding through the educational pathway, 3 have had a full implant. From 14 who failed, 2 are for repeat procedures and 3 for a retrograde approach. No complications at any stage Conclusions: This method of performing a PNE trail to assess if patients with CPP will gain benefit from SNM is safe and effective. 395 PERCENTAGE OF SUCCESSFUL TRIAL WITH PRECISION™ SPINAL CORD STIMULATION IN FAILED BACK SYNDROME A. Dario1 , C. Reverberi2 , G. Tomei1 . 1 Neurosurgical Clinic, Varese Regional Hospital, Varese, 2 Pain Therapy Centre, Oglio-Po Hospital, Cremona, Italy Introduction: The permanent implant after temporary trial ranges is about 80% is so rather rare the percentage of 100% of trial success. Objectives: The aim of this paper is to evaluate the percentage of permanent implantation after trial with Precision™ electrodes in patients suffering from failed back syndrome. Methods: Twelve female patients suffering from drug resistant failed back syndrome has been implanted: four with eight poles percutaneous leads, eight with 16 poles paddle leads. The mean age was 48 years. All but one patients showed complex pain with bilateral leg pain and/or back pain; the other patient had bilateral arm pain. The mean preoperative VAS was 8. All patients were implanted with Precision plus System (Boston Scientific Corp., Valencia California, USA). The stimulation areas and setting used during trial were recorded. Results: All patients showed postoperative underwent to permanent implantation after successful four or five weeks trial period. The mean VAS at follow-up (mean 12 months) was 3.6. all patients used at least two stimulation settings with two or three areas during the trial period. Conclusions: Although this is a little series the permanent implantation percentage of 100% after successful trial has not been reported before. In these patients multiple settings to cover more areas were used to improve pain control.
Posters / European Journal of Pain Supplements 4 (2010) 47–146
pain, we hypothesize to discriminate patients with somatoform pain disorder from healthy controls automatically on a single subject level. Methods: We investigated 13 female patients and 13 gender and age matched healthy controls. During fMRI scanning, we applied a series of alternating noxious and innocuous tonic heat stimuli on the inner side of the left forearm. We used the whole fMRI data time-series including noxious, innocuous, resting conditions for classification analysis. We extracted and scaled the time series of the mean fMRI BOLD signal of 90 defined AAL ROIs with the SPM2 Marsbar Toolbox and concatenated the time-series of all ROIs separately for every subject. The CLASSIF1 software was used for classification (Valet, 993). 10 patients and 10 controls were randomly selected as learning data set; 3 patients and 3 controls were used as test data set (hold-out validation). Results: The accuracy result of classification was 92.3% (1 misclassification, each in the learn and test data set). Relevant discriminating differences of fMRI-BOLD signals between patients and controls were found in memory relevant brain structures, such as Amygdala, Fusiform Cortex, Parahippocampus, as well as the Temporal Cortex. The results match with findings from our recent fMRI study investigating task related changes to noxious stimulation in this patient group (Gundel, ¨ 2008). Conclusions: The CLASSIF1-algorithm as a hypothesis free data analysis approach generates accurate classification results for the individualized discrimination of patients from controls. 393 LONG TERM FOLLOW-UP AFTER CONTINUOUS INTRATHECAL BACLOFEN THERAPY FOR SEVERE SPASTICITY E. Anastasiou1 , A. Tzortzopoulou1,2 , A. Alexandropoulou1 , K. Rizos2 , A. Karakosta1 , A. Kolotoura1 . 1 Anaesthesiology & Pain Clinic, 2 Neurosurgery, ‘Thriassio’ General Hospital of Elefsina, Magoula – Elefsina, Greece Introduction: Baclofen is an agonist of GABA-B receptor which presynaptically inhibits the nerve terminal. Intrathecal baclofen administration via an implantable pump placed subcutaneously in the lateral abdominal area has evolved into a standard treatment for intractable spasticity regardless of origin. Objectives: The purpose of this study was to determine the efficacy and safety of intrathecal baclofen therapy for severe spasticity delivered by a constant flow implantable pump. Methods: A long term observational follow-up study evaluating 30 patients who received intrathecal baclofen via a pump (22 cases with spinal cord related spasticity and 8 cases with cerebral spasticity). The mean follow-up period was 52 months. The initial Ashworth score was 3.7. The average dosage of baclofen was 280 mcg/day. At each follow up visit, clinical efficacy of constant drug administration on spasticity was evaluated by applying Ashworth score. All adverse events and complications were recorded. Results: All but one of the patients responded satisfactorily to therapy. Ashworth score declined from 3.7 to 1.9. Hypotonia and somnolence were the most frequent adverse symptoms. Complications were rare. Technical incidents related to the catheter occurred in 2 patients (6.66%). One patient (3.33%) had cerebrospinal fluid leakage. No infections were reported. In the vast majority of cases there was a remarkable reduction in spasticity and there was an improvement in the psychosocial status of the patients. Conclusions: Continuous intrathecal baclofen infusion for severe refractory spasticity is a reversible procedure providing for appropriately selected patients qualitative and quantitative improvements in quality of life.
394 ARE PERIPHERAL NERVE EVALUATION TRIALS A SAFE AND EFFECTIVE METHOD OF ASSESSING SUITABILITY FOR A SACRO-NEUROMODULATION IMPLANT FOR PELVIC PAIN? J. Cambitzi, A. Baranowski. Pain Management Centre, University College London, London, UK Introduction: Sacral neuromodulation (SNM) is a widely accepted treatment modality for bladder and bowel dysfunction. The therapy has been proven effective and safe and is supported by guidelines. However the use of SNM for the treatment of Chronic Pelvic Pain (CPP) is relatively new. Objectives: This prospective audit aimed to establish whether a relatively inexpensive Peripheral Nerve Evaluation (PNE) trail is a safe and effective method to test the suitability of a patient for implantation of a permanent and expensive SNM device. Methods: SNM of S3 or S4 nerves was obtained by using a transforamenal approach with un-tined lead inserted under x-ray guidance, with patients awake thus optimising placement. The patients were discharged home with external wires; stimulation was achieved using a test stimulator device, manipulated by the patients. Data were collected from patients, on day 3 utilising a pain diary, when wires were removed. Results: 33 patients were considered from the Urogenital pain clinic to received PNE between July 2007–July 2009. 6 patients chose not to enter trail. Out of 27 that received a PNE, 13 achieved therapeutic stimulation, which is defined as a >30% reduction in pain. 10 are proceeding through the educational pathway, 3 have had a full implant. From 14 who failed, 2 are for repeat procedures and 3 for a retrograde approach. No complications at any stage Conclusions: This method of performing a PNE trail to assess if patients with CPP will gain benefit from SNM is safe and effective. 395 PERCENTAGE OF SUCCESSFUL TRIAL WITH PRECISION™ SPINAL CORD STIMULATION IN FAILED BACK SYNDROME A. Dario1 , C. Reverberi2 , G. Tomei1 . 1 Neurosurgical Clinic, Varese Regional Hospital, Varese, 2 Pain Therapy Centre, Oglio-Po Hospital, Cremona, Italy Introduction: The permanent implant after temporary trial ranges is about 80% is so rather rare the percentage of 100% of trial success. Objectives: The aim of this paper is to evaluate the percentage of permanent implantation after trial with Precision™ electrodes in patients suffering from failed back syndrome. Methods: Twelve female patients suffering from drug resistant failed back syndrome has been implanted: four with eight poles percutaneous leads, eight with 16 poles paddle leads. The mean age was 48 years. All but one patients showed complex pain with bilateral leg pain and/or back pain; the other patient had bilateral arm pain. The mean preoperative VAS was 8. All patients were implanted with Precision plus System (Boston Scientific Corp., Valencia California, USA). The stimulation areas and setting used during trial were recorded. Results: All patients showed postoperative underwent to permanent implantation after successful four or five weeks trial period. The mean VAS at follow-up (mean 12 months) was 3.6. all patients used at least two stimulation settings with two or three areas during the trial period. Conclusions: Although this is a little series the permanent implantation percentage of 100% after successful trial has not been reported before. In these patients multiple settings to cover more areas were used to improve pain control.