LDN and tDCS in Fibromyalgia

NCT04502251 | Completed Phase 2

• 1 other identifier: 70005317.5.0000.5307
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tDCS; LDN; Transcranial Direct Current Stimulation; Low Dose Naltrexone

Outcome Measures

Primary Outcomes (1)

• Pain in VAS

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

  Change between baseline and after association (26 days from baseline)

Secondary Outcomes (7)

• Depressive symptoms

  Change between baseline and after association (26 days from baseline)

• Anxiety levels

  Change between baseline and after association (26 days from baseline)

• Pain Catastrophizing Thought

  Change between baseline and after association (26 days from baseline)

• Profile of Chronic Pain

  Change between baseline and after association (26 days from baseline)

• Pain Pressure Threshold

  Change between baseline and after association (26 days from baseline)

Study Arms (4)

LDN + tDCS

ACTIVE COMPARATOR

Low Dose Naltrexone and Transcranial Direct Current Stimulation

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

LDN + Sham tDCS

SHAM COMPARATOR

Low Dose Naltrexone and Sham Transcranial Direct Current Stimulation

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

Placebo + tDCS

PLACEBO COMPARATOR

Placebo and Transcranial Direct Current Stimulation

Device: Transcranial Direct Current Stimulation; Drug: Placebo

Placebo + Sham tDCS

OTHER

Placebo and Sham Transcranial Direct Current Stimulation

Drug: Placebo; Device: Sham Transcranial Direct Current Stimulation

Interventions

Low-Dose Naltrexone DRUG

4.5mg daily dose, orally, during 26 days

Also known as: LDN

LDN + Sham tDCS; LDN + tDCS

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.

Also known as: tDCS

LDN + tDCS; Placebo + tDCS

Placebo DRUG

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

Placebo + Sham tDCS; Placebo + tDCS

Sham Transcranial Direct Current Stimulation DEVICE

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

Also known as: Sham tDCS

LDN + Sham tDCS; Placebo + Sham tDCS

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitario La Salle: lead
• Hospital de Clinicas de Porto Alegre: collaborator

Study Sites (1)

Universidade La Salle

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

Location

Related Publications (35)

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MeSH Terms

Conditions

Fibromyalgia

Interventions

Naltrexone; Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blinded study, in which the participants and the outcomes assessor, who is the same as the investigator and the care provider, are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized, double-blinded, parallel, controlled with placebo and sham stimulation, clinical trial.

Study Record Dates

• First Submitted: July 25, 2020
• First Posted: August 6, 2020
• Study Start: August 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: July 1, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Locations

BR (1)