Dataset Information

A Phase II Multicenter Trial With Rivaroxaban in the Treatment of Livedoid Vasculopathy Assessing Pain on a Visual Analog Scale.

ABSTRACT: BACKGROUND:Livedoid vasculopathy is an orphan skin disease characterized by recurrent thrombosis of the cutaneous microcirculation. It manifests itself almost exclusively in the ankles, the back of the feet, and the distal part of the lower legs. Because of the vascular occlusion, patients suffer from intense local ischemic pain. Incidence of livedoid vasculopathy is estimated to be around 1:100,000. There are currently no approved treatments for livedoid vasculopathy, making off-label therapy the only option. In Europe, thromboprophylactic treatment with low-molecular-weight heparins has become widely accepted. OBJECTIVE:The aim of this trial is the statistical verification of the therapeutic effects of the anticoagulant rivaroxaban in patients suffering from livedoid vasculopathy. METHODS:We performed a therapeutic phase IIa trial designed as a prospective, one-armed, multicenter, interventional series of cases with a calculated sample size of 20 patients. The primary outcome is the assessment of local pain on the visual analog scale (VAS) as an intraindividual difference of 2 values between baseline and 12 weeks. RESULTS:Enrollment started in December 2012 and was still open at the date of submission. The study is expected to finish in November 2014. CONCLUSIONS:Livedoid vasculopathy is associated with increased thrombophilia in the cutaneous microcirculation and the continuous use of anticoagulants helps improve the symptoms. The causes of cutaneous infarctions are heterogenous, but ultimately follow the known mechanisms of the coagulation cascade. Rivaroxaban affects the coagulation cascade and inhibits the factor Xa-dependent conversion of prothrombin to thrombin, thereby considerably reducing the risk of thrombosis. TRIAL REGISTRATION:Trial Registration EudraCT Number: 2012-000108-13-DE; https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000108-13 (Archived by WebCite at http://www.webcitation.org/6UCktWVCA); German Clinical Trials Register (DRKS): DRKS00004652; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004652 (Archived by WebCite at http://www.webcitation.org/6UCIAKyCS).

SUBMITTER: Drabik A

PROVIDER: S-EPMC4275467 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

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A Phase II Multicenter Trial With Rivaroxaban in the Treatment of Livedoid Vasculopathy Assessing Pain on a Visual Analog Scale.

Drabik Attyla A Hillgruber Carina C Goerge Tobias T

JMIR research protocols 20141210 4

<h4>Background</h4>Livedoid vasculopathy is an orphan skin disease characterized by recurrent thrombosis of the cutaneous microcirculation. It manifests itself almost exclusively in the ankles, the back of the feet, and the distal part of the lower legs. Because of the vascular occlusion, patients suffer from intense local ischemic pain. Incidence of livedoid vasculopathy is estimated to be around 1:100,000. There are currently no approved treatments for livedoid vasculopathy, making off-label t ...[more]

PMID: 25500152

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Project description:BACKGROUND:To quantify pain severity in patients and the efficacy treatments, researchers and clinicians apply tools such as the traditional visual analog scale (VAS) that leads to inaccurate interpretation of the main sensory pain. OBJECTIVE:This study aimed to validate the pain measurements of a neuroscience-based 3D body pain mobile app called GeoPain. METHODS:Patients with temporomandibular disorder (TMD) were assessed using GeoPain measures in comparison to VAS and positive and negative affect schedule (PANAS), pain and mood scales, respectively. Principal component analysis (PCA), scatter score analysis, Pearson methods, and effect size were used to determine the correlation between GeoPain and VAS measures. RESULTS:The PCA resulted in two main orthogonal components: first principal component (PC1) and second principal component (PC2). PC1 comprises a combination score of all GeoPain measures, which had a high internal consistency and clustered together in TMD pain. PC2 included VAS and PANAS. All loading coefficients for GeoPain measures in PC1 were above 0.70, with low loadings for VAS and PANAS. Meanwhile, PC2 was dominated by a VAS and PANAS coefficient >0.4. Repeated measure analysis revealed a strong correlation between the VAS and mood scores from PANAS over time, which might be related to the subjectivity of the VAS measure, whereas sensory-discriminative GeoPain measures, not VAS, demonstrated an association between chronicity and TMD pain in locations spread away from the most commonly reported area or pain epicenter (P=.01). Analysis using VAS did not detect an association at baseline between TMD and chronic pain. The long-term reliability (lag >1 day) was consistently high for the pain area and intensity number summation (PAINS) with lag autocorrelations averaging between 0.7 and 0.8, and greater than the autocorrelations for VAS averaging between 0.3 and 0.6. The combination of higher reliability for PAINS and its objectivity, displayed by the lack of association with PANAS as compared with VAS, indicated that PAINS has better sensitivity and reliability for measuring treatment effect over time for sensory-discriminative pain. The effect sizes for PAINS were larger than those for VAS, consequently requiring smaller sample sizes to assess the analgesic efficacy of treatment if PAINS was used versus VAS. The PAINS effect size was 0.51 SD for both facial sides and 0.60 SD for the right side versus 0.35 SD for VAS. Therefore, the sample size required to detect such effect sizes with 80% power would be n=125 per group for VAS, but as low as n=44 per group for PAINS, which is almost a third of the sample size needed by VAS. CONCLUSIONS:GeoPain demonstrates precision and reliability as a 3D mobile interface for measuring and analyzing sensory-discriminative aspects of subregional pain in terms of its severity and response to treatment, without being influenced by mood variations from patients.

Project description:Purpose: To evaluate medium-term clinical outcomes of transcatheter embolization and stenting in women with several pelvic venous disorders responsible for chronic pelvic pain and varicose veins of the lower limbs. Materials and Methods: The study population included 327 consecutively recruited patients referred to the interventional radiology unit from January 2014 to December 2019 due to chronic pelvic congestion (91; 27.83%), lower limb varices (15; 4.59%), or a combination of both the symptoms (221; 67.58%). Preprocedural pelvic, transvaginal Doppler ultrasound (US), and MRI were conducted in all the patients and revealed anatomical varicosities and incompetent pelvic veins in 312 patients. In all the patients, selective catheterization demonstrated uterine venous engorgement, ovarian plexus congestion, or pelvic vein filling. Retrograde flow was detected on catheter venography in the left ovarian vein (250; 78%), the right ovarian vein (85; 26%), the left internal iliac vein (222; 68%), and the right internal iliac vein (185; 57%). Patients were followed-up at 1, 6, and 12 months, and years thereafter systematically by the referring angiologist and the interventional radiologist of center. They were contacted by telephone in November and December 2020 to assess pain perception and quality of life by using the visual analog scales from 0 to 10 with assessments made at the baseline and last follow-up. Of the 327 patients (mean age, 42 ± 12 years), 312 patients were suffering from pelvic congestion syndrome and 236 patients was suffering from lower limb varices. All underwent embolization by using ethylene vinyl alcohol copolymer (Onyx®). Eighty-five right ovarian veins, 249 left ovarian veins, 510 tributaries of the right internal iliac vein, and 624 tributaries of the left internal iliac vein were embolized. A cohort of patients also underwent nutcracker syndrome angioplasty (6.7%) and May-Thurner syndrome angioplasty (14%) with a stent placement. Results: The initial technical success rate was 80.9% for embolization of pathological veins and 100% for stenting of stenoses. Overall, 307 patients attended 12-month follow-up visits and 288 (82%) patients completed the telephone survey at mean 39 (±18)-month postintervention. Main pelvic pain significantly improved from 6.9 (±2.4) pre- to 2.0 (±2.4) postembolization (p < 0.001), as did specific symptoms in each category. Improvement or disappearance of pain was achieved in 266/288 (92.36%) patients with improved quality of life in 276/288 (95.8%) patients. There were 16 minor and 4 major adverse events reported on the follow-up. Conclusion: Pelvic vein embolization (Onyx®) is an effective and safe procedure with high clinical success and quality of life improvement rates.

Dataset Information

A Phase II Multicenter Trial With Rivaroxaban in the Treatment of Livedoid Vasculopathy Assessing Pain on a Visual Analog Scale.

Publications

A Phase II Multicenter Trial With Rivaroxaban in the Treatment of Livedoid Vasculopathy Assessing Pain on a Visual Analog Scale.

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