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OBJECTIVE: The primary objective of this study was to quantify changes in performance of task-specific motor activities over 12 motor rehabilitation sessions with lumbosacral spinal cord stimulation (SCS) via either transcutaneous stimulation or epidural stimulation. Both stimulation modalities have been used in recent years to restore functions lost to spinal cord injury (SCI). Secondary outcomes examine participants' perspectives captured via the User Experience Questionnaire (UEQ) upon study completion to further understand their perception of SCS. METHODS: Six individuals with SCI completed 12 sessions with one modality of SCS during supine and/or side-lying, seated forward reaching, and standing activities. Changes in volitional lower extremity movement, the number of points of contact needed at hips and/or knees to facilitate standing, and changes in seated forward reaching distance were used to quantify performance. The UEQ was administered to gauge participants' perspectives following use of SCS to enable functions impaired due to SCI. RESULTS: For all participants, performance of motor activities improved with SCS compared to without stimulation. Responses for the UEQ showed an overall positive perception of trialing SCS with rehabilitation to enhance motor functions impaired by SCI. CONCLUSIONS: Regardless of injury severity, location of injury, time since SCI, or SCS modality, all participants experienced gains in motor function in the presence of SCS combined with a condensed rehabilitation program. However, no evidence of sustained motor functions was found in the absence of SCS. UEQ results highlight the positive perception of SCS with rehabilitation as well as the importance of consulting persons with lived experience of SCS during clinical trial design and protocol development.Trial registration: ClinicalTrials.gov identifier: NCT05095454.
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ABSTRACT: The primary aim of this randomized clinical trial is to investigate the effects of ultrasound-guided transversus abdominis plane (TAP) vs ultrasound-guided trigger point injections (TPIs) on numerical rating scale pain scores at month 3 follow-up in patients with a chronic abdominal wall pain. The primary outcome measure was the difference in mean numeric rating scale pain scores between the TAP and TPI groups at month 3 in an intent-to-treat (ITT) analysis. A total of 60 patients were randomized 1:1 to receive an ultrasound-guided TAP block (n = 30) or an ultrasound-guided TPI (n = 30). No significant group differences in baseline demographic or clinical characteristics were observed. The mean baseline pain score for the TAP and TPI groups was 5.5 and 4.7, respectively. In the ITT analysis at month 3, the between-group difference in pain scores was 1.7 (95% confidence interval, 0.3-3.0) favoring the TPI group. In a secondary per-protocol analysis, the between-group difference in pain scores was 1.8 (95% confidence interval, 0.4-3.2) favoring the TPI group. For the ITT and per-protocol analyses, the group differences in pain scores were consistent with a medium effect size. The main finding of this randomized clinical trial is that adults with chronic abdominal wall pain who received a TPI reported significantly lower pain scores at month 3 follow-up compared with patients who received a TAP block.
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Parede Abdominal , Músculos Abdominais/diagnóstico por imagem , Parede Abdominal/diagnóstico por imagem , Adulto , Anestésicos Locais , Método Duplo-Cego , Humanos , Dor Pós-Operatória , Estudos Prospectivos , Pontos-Gatilho , Ultrassonografia de IntervençãoRESUMO
OBJECTIVES: Spinal cord stimulation is an evidence-based treatment for a number of chronic pain conditions. While this therapy offers improvement in pain and function it is not without potential complications. These complications include device failure, migration, loss of therapeutic paresthesia, and infection. This article looked to establish a modern infection rate for spinal cord stimulators, assess the impact of known risk factors for surgical site infections and to determine the impact of certain preventative measures on the rate of infection. METHODS: After institutional review board approval, a multisite, retrospective review was conducted on 2737 unique implants or revisions of SCS systems. Patient demographics, risk factors including diabetes, tobacco use, obesity, revision surgery, trial length, implant location, implant type, surgeon background, prophylactic antibiotic use, utilization of a occlusive dressing, and post-operative antibiotic use were recorded and analyzed. RESULTS: The overall infection rate was 2.45% (n = 67). Diabetes, tobacco use, and obesity did not independently increase the rate of infection. Revision surgeries had a trend toward higher infection rate; however, this did not meet statistical significance. There was no difference in the rate of infection between implants performed by physicians of different base specialties, cylinder leads vs. paddle leads, or between different prophylactic antibiotics. Implants performed at academic centers had a higher rate of infection when compared to implants performed in nonacademic settings. When patients received an occlusive dressing or post-operative antibiotics they had a lower rate of infection. CONCLUSIONS: The infection rate (2.45%) reported in this study is lower than the previously reported rates (3-6%) and are on par with other surgical specialties. This study did not show an increased rate of infection for patients that used tobacco, had diabetes or were obese. It's possible that given the low overall infection rate a larger study is needed to establish the true impact of these factors on infection. In addition, this study did not address the impact of poorly controlled diabetes mellitus (elevated hemoglobin A1c) vs. well-controlled diabetes. It can be concluded from this study that utilizing an occlusive dressing over the incision in the post-operative period decreases the rate of infection and should become the standard of care. This study also demonstrated the positive impact of post-operative antibiotics in decreasing the rate of infection. Studies in other surgical specialties have not shown this impact which would suggest that further research is needed.
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Eletrodos Implantados/tendências , Contaminação de Equipamentos , Estimulação da Medula Espinal/tendências , Infecção da Ferida Cirúrgica/diagnóstico , Infecção da Ferida Cirúrgica/etiologia , Adulto , Idoso , Antibacterianos/uso terapêutico , Eletrodos Implantados/efeitos adversos , Eletrodos Implantados/microbiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Estimulação da Medula Espinal/efeitos adversos , Estimulação da Medula Espinal/instrumentação , Infecção da Ferida Cirúrgica/tratamento farmacológicoRESUMO
The aim of this study was to determine whether the magnitude of the intraocular-pressure (IOP)-lowering response in monkeys to the nonselective prostaglandin (PG)F(2a)-isopropyl ester (ie) can be reproduced by combining other PG-subtype-selective compounds. IOP was lowered by approximately 25% after 4-5 days of topical administration with latanoprost (FP agonist, 1.5 microg, q.d.), bimatoprost (prostamide, whose metabolites have been shown to be FP agonists; 9 microg, q.d.), or travoprost (FP agonist, 1.2 microg, q.d) or the EP2 agonist, butaprost (25 microg, b.i.d.). The EP1 agonist, 17-phenyl trinor (PhT) PGE2 (b.i.d.), and EP3 agonist, sulprostone (b.i.d.), had no IOP-lowering effects. The addition of butaprost, sulprostone (10 microg), or 17PhTPGE2 (25 microg) to latanoprost did not lower IOP more than latanoprost alone. However, treatment with the combination of latanoprost, 17PhTPGE2, butaprost, and sulprostone produced a similar 50-55% reduction in IOP, as did PGF(2)alpha-ie (b.i.d.). In conclusion, latanoprost, travoprost, and bimatoprost produce similar IOP-lowering responses in normotensive monkeys and are most efficacious when administered q.d. pm, compared to b.i.d. The combination of the FP, EP1, EP2, and EP3 agonists used in this study was sufficient to lower IOP by the same magnitude as PGF(2)alpha-ie, suggesting that combining PG-subtype agonists may be a potent antiglaucoma strategy.