Ignite Creation Date:
2024-05-06 @ 3:29 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02303886
Status:
COMPLETED
Last Update Posted:
2014-12-01
First Post:
2014-11-16
Brief Title:
Methylene Blue Intravenously and Chronic Neuropathic Pain
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
Evaluation of the Effects of Methylene Blue on Neuropathic Pain and Protein Biomarkers
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim of Investigation Methylene blue MB is a diaminophenothiazine with antioxidant anti-inflammatory properties and with inhibitory effects on nitric oxide The aim of this study was to determine the clinical effectiveness of MB in the treatment of neuropathic pain
Methods Ten patients with neuropathic pain were randomized to receive one of the two treatments methylene blue MB1 2 mgkg 10 mgmL Methyltioninklorid Apoteket Umeå Sweden or methylene blue MB2 002 mgkg Both MB solutions were infused intravenously over 60 minutes The sensory function and the pain were evaluated at baseline and at 60 min after the start of infusions A pain journal was kept by the patients in the following 5 days Plasma and urinary concentrations of 8-isoprostane-prostaglandin F2α 8-iso-PGF2α an indicator of oxidative injury were measured with radioimmunoassay RIA A panel of 92 proteins biomarkers were determined with Proximity Extension Assay PEA prior and after infusions
comparison with the control group MB infusion produced an enhancement of prolactin
Methods Ten patients with neuropathic pain were randomized to receive one of the two treatments methylene blue MB1 2 mgkg 10 mgmL Methyltioninklorid Apoteket Umeå Sweden or methylene blue MB2 002 mgkg Both MB solutions were infused intravenously over 60 minutes The sensory function and the pain were evaluated at baseline and at 60 min after the start of infusions A pain journal was kept by the patients in the following 5 days Plasma and urinary concentrations of 8-isoprostane-prostaglandin F2α 8-iso-PGF2α an indicator of oxidative injury were measured with radioimmunoassay RIA A panel of 92 proteins biomarkers were determined with Proximity Extension Assay PEA prior and after infusions
comparison with the control group MB infusion produced an enhancement of prolactin
Detailed Description:
Patients Study participants were screened from a pool of patients with chronic treatment resistant neuropathic pain and were eligible to participate in the study after giving written informed consent Study design The patients visited the Pain Clinic twice Oral and written information about the study was provided and informed consent obtained Demographic data date of birth sex and ethnic background medical and surgical history were recorded Information about the patients assessments were recorded before the injection including current medication and other successful or non-successful treatment attempts The same investigator AM performed all study procedure assessments Assessments of sensory function were performed before drug administration
Administration of study drug Ten patients were randomized by a computer generated random list to receive either methylene blue 2mgkg 10 mgmL Methyltioninklorid Apoteket Umeå Sweden or methylene blue 002 mgkg that served as control both infused intravenously over 60 minutes After monitors for electrocardiography noninvasive arterial blood pressure and pulse oximetry were attached a dedicated 20-gauge cannula was inserted into the dorsum of the nondominant hand for administration of the study drugs The pain was measured at baseline and at 60 min after the start of infusion NRS scale and also with a pain diary during the next 24 hours and the following 5 days ECG pulse blood pressure O2 saturation were continuously recorded during the infusion Blood and urine samples were taken before and after the infusion of MB Neither the subjects of the experiment nor the person examining the patients knew the concentration of MB in the infusion The infusions of methylene blue in sterile saline NaCl 09 were prepared by another person who had access to the randomization list but not involved in the monitoring of the patients The infusions bags were covered in opaque red wrappes and the infusions sets were opaque
Pain Assessment were performed Before and after MB administration Evaluation of sensory function was performed using bedside examination according to EFNS guidelines light touch pinprick sense warmth 40 and cold 25 temperature stimuli were tested The contralateral uninjured side served as within-patient control The patient compared the sensations in both between sides and reported if there was any hypoesthesia hyperesthesia allodynia or simply normal sensations to the different stimuli The pain recordings were determined before and after infusion of MB Patients kept a diary where they could pick their pain levels on a scale between 0 and 10 NRS at every 6 hours after the infusion in the first 24 hours and at 8 hours in the next 5 days
Peripheral venous blood was drawn from fasting subjects using a 19-gauge needle Urine was collected into additive-free tubes Plasma was prepared from blood collected into tubes containing heparin by centrifugation 3500x g for 12 min Urine and plasma samples were stored at -70C until analysis Blood and urine samples were collected before and after the infusion of MB
Plasma and urine concentrations of isoprostane 8-iso-PGF2 alpha an indicator of oxidative injuryProximity Extension Assay PEA has been found to have specificity of detection and analysis of an increased range of target molecules PEA technology involved in this study a panel of 92 oligonucleotide labeled antibody probe pairs Proseek assay kit Non-parametric statistical methods were performed by the author with GraphPad PRISM 50 GraphPad Software La Jolla San Diego CA wwwgraphpadcom 50 Data are presented as mean and SD with 95 confidence intervals The level of significance was set at a p value 05
Administration of study drug Ten patients were randomized by a computer generated random list to receive either methylene blue 2mgkg 10 mgmL Methyltioninklorid Apoteket Umeå Sweden or methylene blue 002 mgkg that served as control both infused intravenously over 60 minutes After monitors for electrocardiography noninvasive arterial blood pressure and pulse oximetry were attached a dedicated 20-gauge cannula was inserted into the dorsum of the nondominant hand for administration of the study drugs The pain was measured at baseline and at 60 min after the start of infusion NRS scale and also with a pain diary during the next 24 hours and the following 5 days ECG pulse blood pressure O2 saturation were continuously recorded during the infusion Blood and urine samples were taken before and after the infusion of MB Neither the subjects of the experiment nor the person examining the patients knew the concentration of MB in the infusion The infusions of methylene blue in sterile saline NaCl 09 were prepared by another person who had access to the randomization list but not involved in the monitoring of the patients The infusions bags were covered in opaque red wrappes and the infusions sets were opaque
Pain Assessment were performed Before and after MB administration Evaluation of sensory function was performed using bedside examination according to EFNS guidelines light touch pinprick sense warmth 40 and cold 25 temperature stimuli were tested The contralateral uninjured side served as within-patient control The patient compared the sensations in both between sides and reported if there was any hypoesthesia hyperesthesia allodynia or simply normal sensations to the different stimuli The pain recordings were determined before and after infusion of MB Patients kept a diary where they could pick their pain levels on a scale between 0 and 10 NRS at every 6 hours after the infusion in the first 24 hours and at 8 hours in the next 5 days
Peripheral venous blood was drawn from fasting subjects using a 19-gauge needle Urine was collected into additive-free tubes Plasma was prepared from blood collected into tubes containing heparin by centrifugation 3500x g for 12 min Urine and plasma samples were stored at -70C until analysis Blood and urine samples were collected before and after the infusion of MB
Plasma and urine concentrations of isoprostane 8-iso-PGF2 alpha an indicator of oxidative injuryProximity Extension Assay PEA has been found to have specificity of detection and analysis of an increased range of target molecules PEA technology involved in this study a panel of 92 oligonucleotide labeled antibody probe pairs Proseek assay kit Non-parametric statistical methods were performed by the author with GraphPad PRISM 50 GraphPad Software La Jolla San Diego CA wwwgraphpadcom 50 Data are presented as mean and SD with 95 confidence intervals The level of significance was set at a p value 05
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None