LDN and tDCS in Fibromyalgia

August 3, 2020 updated by: Andressa de Souza, Centro Universitario La Salle

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Canoas, Rio Grande Do Sul, Brazil, 92010-000
        • Universidade La Salle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LDN + tDCS
Low Dose Naltrexone and Transcranial Direct Current Stimulation
Drug: Low-Dose Naltrexone
4.5mg daily dose, orally, during 26 days
Other Names:
  • LDN
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.
Other Names:
  • tDCS
Sham Comparator: LDN + Sham tDCS
Low Dose Naltrexone and Sham Transcranial Direct Current Stimulation
Drug: Low-Dose Naltrexone
4.5mg daily dose, orally, during 26 days
Other Names:
  • LDN
Device: Sham Transcranial Direct Current Stimulation
Sham-tDCS stimulation consists of an active current during 30 seconds
Other Names:
  • Sham tDCS
Placebo Comparator: Placebo + tDCS
Placebo and Transcranial Direct Current Stimulation
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.
Other Names:
  • tDCS
Drug: Placebo
The capsule presented the same format, size and color as LDN capsules, however the excipient used was starch.
Other: Placebo + Sham tDCS
Placebo and Sham Transcranial Direct Current Stimulation
Device: Sham Transcranial Direct Current Stimulation
Sham-tDCS stimulation consists of an active current during 30 seconds
Other Names:
  • Sham tDCS
Drug: Placebo
The capsule presented the same format, size and color as LDN capsules, however the excipient used was starch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change between baseline and after association (26 days from baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change between baseline and after association (26 days from baseline)
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)
Change between baseline and after association (26 days from baseline)
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
Change between baseline and after association (26 days from baseline)
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)
Change between baseline and after association (26 days from baseline)
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
Change between baseline and after association (26 days from baseline)
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)
Change between baseline and after association (26 days from baseline)
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)
Change between baseline and after association (26 days from baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Universitario La Salle

Collaborators

Hospital de Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

July 25, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70005317.5.0000.5307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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