Methylene Blue Intravenously and Chronic Neuropathic Pain

What Was Tested

This registered not phased trial tested Methylene blue (non-peptide stack partner) for chronic pain: fibromyalgia & crps.

Aim of Investigation Methylene blue (MB) is a diaminophenothiazine with antioxidant, anti-inflammatory properties and with inhibitory effects on nitric oxide.

It had two arms (groups): one (active comparator) and one (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

10 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Methylene blue (non-peptide stack partner) and who got the comparison, which limits bias.

Each person switched between Methylene blue (non-peptide stack partner) and the comparison at some point, usually with a gap in between.

Neither the chronic pain: fibromyalgia & crps participants nor the staff measuring them knew who was on Methylene blue (non-peptide stack partner), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2009-03 with completion listed for 2012-06.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pain (visual analogue scale) (time frame: 60 min, every 6 hours after the infusion in the first 24 hours and at 8 hours in the next 5 days).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 10 people with chronic pain: fibromyalgia & crps.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, Chronic pain: fibromyalgia & CRPS research.