LDN and tDCS in Fibromyalgia

• Status: Completed
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Universitario La Salle
• Collaborator: Hospital de Clinicas de Porto Alegre
• Treatments: Naltrexone

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.