LDN and tDCS in Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Drug: PlaceboDevice: Sham Transcranial Direct Current StimulationDevice: Transcranial Direct Current Stimulation
- Registration Number
- NCT04502251
- Lead Sponsor
- Centro Universitario La Salle
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 92
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LDN + Sham tDCS Sham Transcranial Direct Current Stimulation Low Dose Naltrexone and Sham Transcranial Direct Current Stimulation LDN + tDCS Transcranial Direct Current Stimulation Low Dose Naltrexone and Transcranial Direct Current Stimulation Placebo + Sham tDCS Placebo Placebo and Sham Transcranial Direct Current Stimulation LDN + tDCS Low-Dose Naltrexone Low Dose Naltrexone and Transcranial Direct Current Stimulation LDN + Sham tDCS Low-Dose Naltrexone Low Dose Naltrexone and Sham Transcranial Direct Current Stimulation Placebo + tDCS Transcranial Direct Current Stimulation Placebo and Transcranial Direct Current Stimulation Placebo + tDCS Placebo Placebo and Transcranial Direct Current Stimulation Placebo + Sham tDCS Sham Transcranial Direct Current Stimulation Placebo and Sham Transcranial Direct Current Stimulation
- Primary Outcome Measures
Name Time Method Pain in VAS 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 Outcome Measures
Name Time Method Pain Catastrophizing Thought 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
Depressive symptoms 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)
Anxiety levels 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)
Profile of Chronic Pain 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)
Pain Pressure Threshold 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
Conditioned Pain Modulation 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)
Serum BDNF 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)
Trial Locations
- Locations (1)
Universidade La Salle
🇧🇷Canoas, Rio Grande Do Sul, Brazil