NCT04502251

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Centro Universitario La Salle · Academic / Other
• Sex: Female
• Age: 8 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Low-Dose Naltrexone	4.5mg daily dose, orally, during 26 days
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.
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

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-08-01
• Completion: 2020-07-01
• First posted: 2020-08-06
• Last updated: 2020-08-06

Locations

1 site across 1 country: Brazil