Methylene Blue Intravenously and Chronic Neuropathic Pain

NCT02303886 | Completed

• 1 other identifier: NO8
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Pain (visual analogue scale)

  VAS

  60 min, every 6 hours after the infusion in the first 24 hours and at 8 hours in the next 5 days

Study Arms (2)

A Methylene blue 10 mg/ml 2mg/kg

ACTIVE COMPARATOR

ten patients that recieved MB1 methylene blue 2 mg/kg infusion under 60 min

Drug: Methylene blue

B Methylene blue 10 mg/ml 0.02 mg/kg

PLACEBO COMPARATOR

Same patients received MB2 Methylene blue 0.02 mg/kg infusion under 60 min

Drug: Methylene blue

Interventions

Methylene blue DRUG

In NaCL0.9% 100 ml

Also known as: methylthioninium chloride

A Methylene blue 10 mg/ml 2mg/kg; B Methylene blue 10 mg/ml 0.02 mg/kg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male subjects \> 18 years of age
• Be able to understand and comply with the requirements of the study
• Patients with a history of persistent peripheral and central neuropathic pain interfering with daily activities of at least 3 months duration
• Patients with previous unsuccessful treatment of neuropathic pain
• Spontaneous or evoked pain upon standardized test (mechanical, movement)\> 50 on a 100 mm VAS scale
• Informed written consent

You may not qualify if:

• Any condition that may confound assessment of pain (acute pain)
• Any condition/disease that could interfere with the study measurements, e.g. peripheral vascular disease, diabetes mellitus, alcohol/opioids addiction
• Noncooperation, insufficient Swedish language
• Treatment with antidepressants, antiepileptics, opioids, lidocaine patches was not accepted the day before and the day of the visit
• Pregnancy
• Treatment with NO releasing drugs, anti-cytokine therapy
• Diabetes mellitus type I, malignancy, increased pulmonary hypertension, cardiac ischemic disease, decreased glomerular filtration rate\<30 ml/min, decreased liver function, Glu-6-PDH deficiency

Sponsors & Collaborators

• Uppsala University: lead

MeSH Terms

Conditions

Neuralgia

Interventions

Methylene Blue

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Adriana Miclescu

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, DEAA

Study Record Dates

• First Submitted: November 16, 2014
• First Posted: December 1, 2014
• Study Start: March 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: November 1, 2014
• Last Updated: December 1, 2014

Record last verified: 2014-11