Neuromodulation : journal of the International Neuromodulation Society
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Multicenter Study
Composite Score Is a Better Reflection of Patient Response to Chronic Pain Therapy Compared With Pain Intensity Alone.
The pain Numeric Rating Scale (NRS) score became standard when pain was introduced as the fifth vital sign in the 1990s. Although plagued with issues, it remains the basis for primary outcome measures in clinical trials for chronic pain therapies. Multidimensional composite scoring that considers all aspects of the chronic pain experience may provide a more meaningful response measure. Herein we propose a multidimensional responder index. ⋯ Our study suggests that therapeutic response, similar to the chronic pain experience, is multidimensional. Careful consideration should be made to incorporate composite endpoints in future SCS clinical trials.
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Randomized Controlled Trial Multicenter Study
Neuromodulation With Burst and Tonic Stimulation Decreases Opioid Consumption: A Post Hoc Analysis of the Success Using Neuromodulation With BURST (SUNBURST) Randomized Controlled Trial.
The SUNBURST study was a prospective, multicenter, randomized crossover trial of a single device delivering burst and tonic spinal cord stimulation (SCS) for chronic trunk and/or limb pain. We performed a post hoc analysis of opioid consumption at baseline and after device implantation. ⋯ A device delivering tonic and burst SCS was associated with decreased opioid consumption after 12 months in patients with chronic trunk and/or limb pain. The proportion of patients reporting the highest opioid intake (>120 MME/day) decreased to a lower CDC dose category by 61.7%, carrying important implications for those at highest risk for opioid-related substance use disorder, overdose, and death.
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Multicenter Study
Pain Catastrophizing Does Not Predict Spinal Cord Stimulation Outcomes: A Cohort Study of 259 Patients With Long-Term Follow-Up.
Spinal cord stimulation (SCS) is an important treatment modality used to treat chronic neuropathic pain. However, reported success rates of 26%-70% entail an increased focus on patient selection. An area of core interest is psychological evaluation, often using scales such as the Pain Catastrophizing Scale (PCS). The aim of this study was to assess the relation between baseline PCS scores obtained before implantation and SCS outcomes defined as (1) Rating on Patients' Global Impression of Change scale (PGIC), (2) Pain relief on the Numeric Rating Scale (NRS), (3) Cessation of pain medication, and (4) Risk of permanent explantation. ⋯ This study did not demonstrate any associations between baseline PCS scores and SCS outcomes.
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Multicenter Study
Analysis of the Correlation Between the Clinical Effect of Sacral Neuromodulation and Patient Age: A Retrospective Multicenter Study in China.
This study aimed to evaluate whether patients stratified by age have the same level of benefits after a sacral neuromodulation (SNM) procedure for refractory lower urinary tract dysfunction. ⋯ SNM success is unrelated to age, and age alone should not be considered a limiting factor in SNM. For older patients, an overactive bladder appears a better indication for SNM treatment; however, further studies are required to confirm this finding.
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Case Reports Multicenter Study
Intrathecal Baclofen for Severe Spasticity: Longitudinal Data From the Product Surveillance Registry.
To assist in the assessment of intrathecal baclofen (ITB) therapy risks and benefits by providing surgical intervention rate, safety, and elective device replacement rate data. ⋯ ITB therapy for the treatment of severe spasticity requires surgical implantation of a programmable infusion system for chronic drug delivery. If complications arise, many necessitate surgical intervention for correction. For spinal and cerebral spasticity in pediatric and adult patients, discontinuation rates due to an adverse event were low (0.3%), and there was high acceptance (99.1%) of surgical intervention for therapy continuation. Patient/caregiver willingness to accept surgical and other risks for therapy continuation was extremely high.