Trial | NCT04502251  Report issue

Title

LDN and tDCS in Fibromyalgia
Association of Low Doses of Naltrexone and Transcranial Direct Current Stimulation in Fibromyalgia: Randomized Clinical Trial, Blind, Controlled With Placebo

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Low-Dose Naltrexone ...

  • Study Participants

    92
Fibromyalgia is a complex generalized and diffuse musculoskeletal chronic pain; and pharmacological approaches are widely used to relieve pain and increase life quality. In this context, low-dose naltrexone (LDN) was able to increase nociceptive threshold in patients with fibromyalgia. Moreover, non-pharmacological techniques, like Transcranial Direct Current Stimulation (tDCS), have been shown effective for pain management. This study aims to evaluate the analgesic and neuromodulatory effect of combined LDN followed by tDCS in fibromyalgia patients. This is a randomized, double-blinded, parallel, placebo/sham-controlled trial, in which 92 (10% loss) women with fibromyalgia will be included included and signed the informed consent. Patients will be allocated into 4 groups: tDCS+LDN (n=21), Sham-tDCS+LDN (n=22), tDCS+Placebo (n=22), and Sham-tDCS+Placebo (n=21). LDN or placebo (p.o.) intervention lasts 26 days, in the last five, tDCS will be applied (sham or active, 20min, 2mA). Questionnaires assessed are: Sociodemographic, Visual Analog Pain Scale (VAS), Pain Catastrophizing Scale (PCS), State-Trait Anxiety Inventory (STAI), Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI-II), Chronic Pain Profile Scale (CPP). Also, pain measures were taken: Pain Pressure Threshold (PPT) and Conditioned Pain Modulation (CPM). Blood samples will be collected to analyze Brain Derived Neurotrophic Factor (BDNF) serum levels.
Study Started
Aug 01
2018
Primary Completion
Aug 01
2019
Study Completion
Jul 01
2020
Last Update
Aug 06
2020

Drug Low-Dose Naltrexone

4.5mg daily dose, orally, during 26 days

  • Other names: LDN

Device Transcranial Direct Current Stimulation

An anodal electrode was placed on the scalp above the primary motor cortex (M1), contralateral to the dominant cortex. The cathodal electrode was placed on the supraorbital contralateral area. The current used was 2mA during 20 minutes.

  • Other names: tDCS

Drug Placebo

The capsule presented the same format, size and color as LDN capsules, however the excipient used was starch.

Device Sham Transcranial Direct Current Stimulation

Sham-tDCS stimulation consists of an active current during 30 seconds

  • Other names: Sham tDCS

LDN + tDCS Active Comparator

Low Dose Naltrexone and Transcranial Direct Current Stimulation

LDN + Sham tDCS Sham Comparator

Low Dose Naltrexone and Sham Transcranial Direct Current Stimulation

Placebo + tDCS Placebo Comparator

Placebo and Transcranial Direct Current Stimulation

Placebo + Sham tDCS Other

Placebo and Sham Transcranial Direct Current Stimulation

Criteria 

Inclusion Criteria:

signed the consent form
women from 18 to 65 years
confirmed diagnosis of fibromyalgia according 2016 American College of Rheumatology criteria
read and write
pain higher than 6 in the Visual Analogue Scale (VAS), in the last 3 months
chronic stable treatment in the last 3 months.

Exclusion Criteria:

in use of opioid drugs;
pregnancy or not using anticontraceptive
history of alcohol or drug abuse in the last 6 months
history of neurological pathologies
history of arrhythmia
history of use of drugs that might change vascular response
history of head trauma
history of neurosurgery
decompensated systemic diseases or chronic inflammatory diseases (lupus, rheumatoid arthritis, Sjogren syndrome, Reiter syndrome)
history of non-compensated hypothyroidism
personal history of cancer.
No Results Posted