Neuropathic Pain Clinical Trial
Official title:
Evaluation of the Effects of Methylene Blue on Neuropathic Pain and Protein Biomarkers
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 mg/kg (10 mg/mL Methyltioninklorid, Apoteket, Umeå,
Sweden) or methylene blue (MB2) 0.02 mg/kg. 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.
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 2mg/kg (10 mg/mL Methyltioninklorid, Apoteket, Umeå,
Sweden) or methylene blue 0.02 mg/kg (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 0.9%) 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 −70◦C 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
injury),Proximity 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 5.0 (GraphPad Software,
La Jolla, San Diego, CA, www.graphpad.com 5.0). Data are presented as mean and SD with 95%
confidence intervals. The level of significance was set at a p value <.05.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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