LDN and tDCS in Fibromyalgia

Centro Universitario La Salle

Status and phase: Completed; Phase 3; Phase 2

Conditions: Fibromyalgia

Treatments: Drug: Placebo; Drug: Low-Dose Naltrexone; Device: Sham Transcranial Direct Current Stimulation; Device: Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04502251

70005317.5.0000.5307

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: Female

Ages: 8 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 4 patient groups, including a placebo group

LDN + tDCS

Active Comparator group

Description:

Low Dose Naltrexone and Transcranial Direct Current Stimulation

Treatment:

Device: Transcranial Direct Current Stimulation

Drug: Low-Dose Naltrexone

LDN + Sham tDCS

Sham Comparator group

Description:

Low Dose Naltrexone and Sham Transcranial Direct Current Stimulation

Treatment:

Device: Sham Transcranial Direct Current Stimulation

Drug: Low-Dose Naltrexone

Placebo + tDCS

Placebo Comparator group

Description:

Placebo and Transcranial Direct Current Stimulation

Treatment:

Device: Transcranial Direct Current Stimulation

Drug: Placebo

Placebo + Sham tDCS

Other group

Description:

Placebo and Sham Transcranial Direct Current Stimulation

Treatment:

Device: Sham Transcranial Direct Current Stimulation

Drug: Placebo