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NCT Number: NCT04502251

LDN and tDCS in Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

8 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Universidade La Salle

Canoas, Rio Grande do Sul, 92010-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-Dose Naltrexone

Drug

4.5mg daily dose, orally, during 26 days

Other names: LDN

Transcranial Direct Current Stimulation

Device

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

Placebo

Drug

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

Sham Transcranial Direct Current Stimulation

Device

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

Other names: Sham tDCS

Primary outcomes

  1. Pain in VAS

    Time frame: Change between baseline and after association (26 days from baseline)

    Visual Analogue Scale (VAS) that goes from 0 cm (without pain) to 10cm (worst pain).

Secondary outcomes

  1. Depressive symptoms

    Time frame: Change between baseline and after association (26 days from baseline)

    Beck Depression Inventory (BDI-II) that goes from 0 (without depressive symptoms) to 63 (worst depressive symptoms)

  2. Anxiety levels

    Time frame: Change between baseline and after association (26 days from baseline)

    State-Trait Anxiety Inventory (STAI) divided into state anxiety (from 0 to 52, the higher the worse) and trait anxiety (from 0 to 48, the higher the worse)

  3. Pain Catastrophizing Thought

    Time frame: Change between baseline and after association (26 days from baseline)

    Pain Catastrophizing Scale (PCS): divided into rumination (from 0 to 16, the higher the worse), magnification (from 0 to 12, the higher the worse) and hopelessness (from 0 to 24, the higher the worse). Total goes from 0 to 52, the higher the worse

  4. Profile of Chronic Pain

    Time frame: Change between baseline and after association (26 days from baseline)

    Profile of Chronic Pain Scale (PCP:S): divided into Frequency and Intensity of Pain (from 0 to 30, the higher the worse), Pain Effect in Activities (from 0 to 36, the higher the worse) and Pain Effect in Emotions (from 0 to 25, the higher the worse)

  5. Pain Pressure Threshold

    Time frame: Change between baseline and after association (26 days from baseline)

    Pain Pressure Threshold (PPT) measured using an electronic algometer applied in the right forearm; and patients need to report the first pain sensation (minimum pain) and maximum pain. Threshold goes from 0 to the maximum value the patient can hold, the higher the value, better is the result

  6. Conditioned Pain Modulation

    Time frame: Change between baseline and after association (26 days from baseline)

    Conditioned Pain Modulation (CPM) with an algometer (PPT task), the patient informed when felt a pain equal to 6 in the VAS. This pain level was applied in the right forearm for 30 seconds, while the left forearm (non-dominant hand) was submerged in water from 0˚C to 1.5˚C; after 30s, patients reported their pain in each of the arms. CPM = left forearm VAS - 6. (from -4 to 6, the value must be as closest to -4 as possible, meaning the higher the worse)

  7. Serum BDNF

    Time frame: Change between baseline and after association (26 days from baseline)

    Blood sample collected and centrifuged, the supernatant aliquoted for BDNF analysis using ELISA technique, according to manufacturer's instructions (values start in 0, patients with fibromyalgia usually have higher levels of serum BDNF, therefore the higher the worse)

Sponsors and collaborators

Lead sponsor

Centro Universitario La Salle

Other

Collaborators

  • Hospital de Clinicas de Porto Alegre

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 6, 2020
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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