Paolo Poli

Cost-Effectiveness and Cost-Utility Analysis of Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome: Results From the PRECISE Study

To assess the cost‐effectiveness and cost‐utility of Spinal Cord Stimulation (SCS) in patients with failed back surgery syndrome (FBSS) refractory to conventional medical management (CMM).

Chronic Low Back Pain: Perception and Coping With Pain in the Presence of Psychiatric Comorbidity.

Abstract This retrospective study investigated the influence of psychiatric comorbidity on pain perception and coping with pain in tertiary pain clinic patients, 427 treated for chronic low back pain (CLBP) and 629 for other forms of chronic pain (CG). No differences in psychosomatic dimensions were found between the two groups, but Italian Pain Questionnaire dimensions and intensity scores (t = 7.35; p < 0.0001) were higher in CLBP than in CG subjects. According to the Mini-International Neuropsychiatric Interview, CLBP patients also had a higher prevalence of lifetime major depressive episodes (&khgr;2 = 4.96; p < 0.05), dysthymic disorder (&khgr;2 = 4.64; p < 0.05), suicide risk (&khgr;2 = 10.43; p < 0.01), and agoraphobia (&khgr;2 = 6.31; p < 0.05) than CG patients did. The Multidimensional Pain Inventory showed a close association between CLBP and both agoraphobia (&khgr;2 = 3.74; p < 0.05) and dysfunctional coping style (&khgr;2 = 8.25; p < 0.01), which increased disability. Both agoraphobia and lifetime depression were associated with an overall increase in dimensions and pain intensity in CLBP, but not in CG.

An Emerging Dimension in Psychosomatic Research: The Nocebo Phenomenon in the Management of Chronic Pain

Introduction. The nocebo effect consists in delivering verbal suggestions of negative outcomes so that the subject expects clinical worsening. Several studies indicate that negative verbal suggestions may result in the amplification of pain. Amplification style is one of the most important dimensions in psychosomatic research. Methods. One group of pain therapy unit patients was evaluated at baseline and again after 6 months from the beginning of the pain treatment. Results. Only 43% of 86 chronic pain patients respond positively to the expectation of sham pain. This group shows at baseline higher pain intensity (t value: 2.72, P = 0.007) and lower cold pain threshold (t value: 2.18, P = 0.03) than the group of subjects with any response to sham pain stimulus. Somatoform dimensions influence positively the strength of nocebo response in those predisposed to it. Conclusion. Our study shows that the power of the nocebo phenomenon seems to be a dimension belonging to the investigation in psychosomatic. In contrast to what one might expect, the presence of the nocebo phenomenon affects positively pain relief and the outcome of pain treatment. In a clinical setting, and the meaning of nocebo response does not seem to be different from placebo response.

Psychiatric Predisposition to Autonomic and Abnormal Perception Side-Effects of Ziconotide: A Case Series Study

Introduction:  Ziconotide is a reversible blocker of the N‐type neuronal voltage‐sensitive calcium channels with analgesic effects. The main adverse effects of ziconotide are ataxia, dizziness, gait disorder, confusion, hallucinations, and gastrointestinal symptoms.

Biopsychosocial Aspects of Atypical Odontalgia

Background. A few studies have found somatosensory abnormalities in atypical odontalgia (AO) patients. The aim of the study is to explore the presence of specific abnormalities in facial pain patients that can be considered as psychophysical factors predisposing to AO. Materials and Methods. The AO subjects (n = 18) have been compared to pain-free (n = 14), trigeminal neuralgia (n = 16), migraine (n = 17), and temporomandibular disorder (n = 14). The neurometer current perception threshold (CPT) was used to investigate somatosensory perception. Structured clinical interviews based on the DSM-IV axis I and DSM III-R axis II criteria for psychiatric disorders and self-assessment questionnaires were used to evaluate psychopathology and aggressive behavior among subjects. Results. Subjects with AO showed a lower Aβ, Aδ, and C trigeminal fiber pain perception threshold when compared to a pain-free control group. Resentment was determined to be inversely related to Aβ (rho: 0.62, P < 0.05), Aδ (rho: 0.53, P < 0.05) and C fibers (rho: 0.54, P < 0.05), and depression was inversely related with C fiber (rho: 0.52, P < 0.05) perception threshold only in AO subjects. Conclusion. High levels of depression and resentment can be considered predictive psychophysical factors for the development of AO after dental extraction.

Il costo della sindrome da fallimento chirurgico spinale (Failed Back Surgery Syndrome, FBSS) nei pazienti con indicazione a impianto per neurostimolazione midollare in Italia

ObjectiveTo assess the costs and clinical condition of Failed Back Surgery Syndrome (FBSS) for patients eligible for Spinal Cord Stimulation (SCS) in Italy.MethodsA multicentre, retrospective data collection with a maximum time horizon of 12 months was developed. Nine Italian Centers experienced in SCS were involved enrolling 80 patients. Use and costs of healthcare and non-healthcare resources, clinical condition and HR-QoL data were collected through specific questionnaires submitted to patients. Mean monthly costs (EUR 2008) were evaluated according to three perspectives: Patient, National Healthcare System (NHS) and Society.ResultsA strong impairment in baseline HR-QoL was documented. Mean utility score was 0.07 (general UK population: 0.70). According to the Oswestry questionnaire, 44% of patients were crippled and 39% severely disabled. All SF-36 dimensions were worse than in normal population. To treat FBSS, monthly expenditure per patient was equal to €177.34, €221.12 and €1,046.12 from the perspectives of Patient, NHS and Society, respectively. Productivity losses accounted for 62% of the societal total costs, while hospitalizations explained 28% of the costs sustained by the NHS. From the patient perspective, the main cost drivers were home care (27%) and travel expenses (26%).ConclusionsThis Cost-of-Illness analysis confirms FBSS as a disabling and costly disease.

Somatisation and function of HPA in fibromyalgia: an investigation using sham and true pain stimuli

Introduction: Studies have shown hypothalamic-pituitary-adrenal (HPA) dysfunction in fibromyalgia, particularly when associated with depression or anxiety. Although research has demonstrated a close relationship between fibromyalgia and somatoform disorder, there is as yet no literature on how this association affects HPA activity in fibromyalgia. We set out to investigate the influence of somatoform dimensions on HPA activity using nocebo and cold pressure test (CPT) stimuli. Method: HPA activity was compared in fibromyalgia patients (n. 20 females) and pain-free controls (n. 14 females) using a one-way between-subjects design. Blood samples were taken at 10:00–10:30 am on the tenth day after the start of menstruation in both groups, and on two consecutive days thereafter, to measure levels of cortisol and ACTH. Nocebo testing and CPT were performed in both groups 30 minutes before this procedure on days 2 and 3, respectively. The Somatosensory Amplification Scale (SSAS), Illness Behaviour Questionnaire, and Somatoform Dissociation Questionnaire 20 were used to investigate somatoform dimensions. Results and conclusions: Fibromyalgia subjects showed a statistically significant blunted cortisol variation after these three stressful stimuli, as compared to controls (F=4.41 p=0.03), a difference that was correlated with increased Somatosensory Amplification (F=6.77; p=0.01). Correspondence to: Antonella Ciaramella, Aplysia onlus, GIFT Institute for Integrative Medicine, p.za Cairoli 12, 56127 Pisa, Italy, E-mail: ciarantogift@gmail.com / antonella.ciaramella@medpat.unipi.it

Relationship between Pain, Functional Disability and Health-Related Quality of Life in Patient with Failed Back Surgery Syndrome Undergoing Spinal Cord Stimulation: Results from the Precise Study

Objectives: Osteoarthritis (OA) is the most common and costly bone and joint disease in the elderly. Recently, viscosupplementation, an intra-articular injection of artificial joint fluid in order to restore rheological properties affecting lubrication and shock absorption, has introduced as an alternative conservative treatment. To assess the effectiveness and cost-effectiveness of Hylan G-F 20 (Hylan) as a substitute for existing treatments for pain due to OA of the knee, other viscosupplementation devices, and/or as an adjunct to conventional therapy. MethOds: A Markov microsimulation model was developed to define a treatment pathway for OA of the knee, illustrate the current costs of treating patients with the condition, and demonstrate the potential savings associated with introduction of Hylan. A hypothetical cohort of patients categorized as having 2-3 or 4 degree of OA of the knee was followed over a 30-month time period. Results: When comparing intra-articular administration of Hylan, the use of NSAIDs and intra-articular administration of corticosteroids (GCS), rirost costs compared with the strategy of NSAIDs amounted to

Il costo della sindrome da fallimento chirurgico spinale (Failed Back Surgery Syndrome, FBSS) nei pazienti con indicazione a impianto per neurostimolazione midollare in Italia@@@The Cost of Illness of Failed Back Surgery Syndrome for patients eligible for Spinal Cord Stimulation in Italy

192 rate per 1 patient. This increase in efficiency of 20% in favor of Hylan. Accordingly, the ratio ICER was

The cost of illness of failed back surgery syndrome for patients eligible for spinal cord stimulation in Italy[Il costo della sindrome da fallimento chirurgico spinale (failed back surgery syndrome, FBSS) nei pazienti con indicazione a impianto per neurostimolazione midollare in Italia]

979 per patient, which is much below the threshold of “society’s willingness to pay.” Markov cycle for patients with OA of the knee of 4 degrees showed that use of Hylan is more effective in the end point of modeling the effectiveness of this strategy was 12% (compared to 0% in the policies of NSAIDs and corticosteroids). We calculated the total cost of the budget in the application of NSAIDs, GCS, and Hylan, after calculations found that the use of Gilan can save significant budget funds up to