Methylene Blue Intravenously and Chronic Neuropathic Pain

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uppsala University
• Treatments: Methylene Blue

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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