Clinical trial NCT04502251: LDN and tDCS in Fibromyalgia
Official title: Association of Low Doses of Naltrexone and Transcranial Direct Current Stimulation in Fibromyalgia: Randomized Clinical Trial, Blind, Controlled With Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Fibromyalgia
Keywords: tDCS
LDN
Transcranial Direct Current Stimulation
Low Dose Naltrexone
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas de Porto Alegre
First posted: 2020-08-06
Enrollment: 92
Sex: FEMALE
Minimum age (years): 8
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blinded, parallel, controlled with placebo and sham stimulation, clinical trial.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Pain in VAS
timeFrame: Change between baseline and after association (26 days from baseline)
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Change between baseline and after association (26 days from baseline)
measure: Anxiety levels
timeFrame: Change between baseline and after association (26 days from baseline)
measure: Pain Catastrophizing Thought
timeFrame: Change between baseline and after association (26 days from baseline)
measure: Profile of Chronic Pain
timeFrame: Change between baseline and after association (26 days from baseline)
measure: Pain Pressure Threshold
timeFrame: Change between baseline and after association (26 days from baseline)
measure: Conditioned Pain Modulation
timeFrame: Change between baseline and after association (26 days from baseline)
measure: Serum BDNF
timeFrame: Change between baseline and after association (26 days from baseline)
Other outcomes:
Locations:
city: Canoas
country: Brazil
facility: Universidade La Salle
state: Rio Grande Do Sul
Study officials:
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