Trial reportBrazilian journal of anesthesiology (Elsevier)
Association of low-dose naltrexone and transcranial direct current stimulation in fibromyalgia: a randomized, double-blinded, parallel clinical trial.
Trial report in Brazilian journal of anesthesiology (Elsevier). The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04502251 (Association of Low Doses of Naltrexone and Transcranial Direct Current Stimulation in Fibromyalgia), which is not on this map. Cited by 21 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Association of Low Doses of Naltrexone and Transcranial Direct Current Stimulation in Fibromyalgia: Randomized Clinical Trial, Blind, Controlled With Placebo
Who cites it
21 citing papers in PubMed, 5 syntheses or guidelines pooled it, 28 citations in OpenAlex.
- Low Dose Naltrexone In The Management Of Chronic Pain Syndrome: A Meta-Analysis Of Randomized Controlled Clinical Trials.Current pain and headache reports · 2025Pooled it
- Transcranial Electrical Stimulation in Treatment of Depression: A Systematic Review and Meta-Analysis.JAMA network open · 2025Pooled it
- Clinical, neurophysiological and neurochemical effects of non-invasive electrical brain stimulation in fibromyalgia syndrome-a systematic review and meta-analysis.Frontiers in pain research (Lausanne, Switzerland) · 2025Pooled it
- Brain stimulation targets for chronic pain: Insights from meta-analysis, functional connectivity and literature review.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2024Pooled it
- The use of naltrexone in the treatment of chronic pain: a systematic review.Pain management · 2024Pooled it
- Efficacy of Low-Dose Naltrexone in Women With Fibromyalgia Syndrome: A 12-Month Randomised, Double-Blind, Placebo-Controlled Single-Centre Clinical Trial (INNOVA Study).European journal of pain (London, England) · 2026Trial
- Low-Dose Naltrexone: What is the Evidence? A Narrative Review.Advances in therapy · 2026Review
- Non-Invasive Brain Stimulation for Core Symptoms of Chronic Primary Pain: A Meta-Analysis of RCTs.Brain sciences · 2026Review
- Authors' reply to the letter to the editor regarding "Low-dose naltrexone for fibromyalgia: a re-analysis suggests lower efficacy than previously reported".The Korean journal of pain · 2026Article
- Low-dose naltrexone for fibromyalgia: a re-analysis suggests lower efficacy than previously reported.The Korean journal of pain · 2026Article
- Authors' response to comments on "Efficacy and safety of low-dose naltrexone for the management of fibromyalgia: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis".The Korean journal of pain · 2025Article
- Review
- Quantitative Sensory Testing in Fibromyalgia Syndrome: A Scoping Review.Biomedicines · 2025Review
- Review
- Physical Modalities for the Treatment of Pain in Patients with Fibromyalgia.Mediterranean journal of rheumatology · 2025Review
- Efficacy and safety of low-dose naltrexone for the management of fibromyalgia: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis.The Korean journal of pain · 2024Article
- The Link between Endogenous Pain Modulation Changes and Clinical Improvement in Fibromyalgia Syndrome: A Meta-Regression Analysis.Biomedicines · 2024Review
- Brain-Derived Neurotrophic Factor, Nociception, and Pain.Biomolecules · 2024Review
- Review
- Non-Invasive Electric and Magnetic Brain Stimulation for the Treatment of Fibromyalgia.Biomedicines · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionFibromyalgia is a complex, generalized, and diffuse chronic musculoskeletal pain. Pharmacological approaches are widely used to relieve pain and increase quality of life. Low-Dose Naltrexone (LDN) was shown to increase the nociceptive threshold in patients with fibromyalgia. Transcranial Direct Current Stimulation (tDCS) is effective for pain management.
objectiveThe purpose of this study was to evaluate the analgesic and neuromodulatory effects of a combination of LDN and tDCS in patients with fibromyalgia.
methodsThis was a randomized, double-blinded, parallel, placebo/sham-controlled trial (NCT04502251; RBR-7HK8N) in which 86 women with fibromyalgia were included, and written informed consent was obtained from them. The patients were allocated into four groups: LDN + tDCS (n = 21), LDN + tDCS Sham (n = 22), placebo + tDCS (n = 22), and placebo+tDCS Sham (n = 21). The LDN or placebo (p.o.) intervention lasted 26 days; in the last five sessions, tDCS was applied (sham or active, 20 min, 2 mA). The following categories were assessed: sociodemographic, Visual Analog Pain Scale (VAS), Pain Catastrophizing Scale (PCS), State-Trait Anxiety Inventory (STAI), Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI-II), Profile of Chronic Pain Scale (PCP:S), Pain Pressure Threshold (PPT), and Conditioned Pain Modulation (CPM). Blood samples were collected to analyze BDNF serum levels.
resultsAt baseline, no significant difference was found regarding all measurements. VAS pain was significantly reduced in the LDN + tDCS (p = 0.010), LDN + tDCS Sham (p = 0.001), and placebo+tDCS Sham (p = 0.009) groups. In the PCP:S, the LDN+tDCS group showed reduced pain frequency and intensity (p = 0.001), effect of pain on activities (p = 0.014) and emotions (p = 0.008). Depressive symptoms reduced after all active interventions (p > 0.001).
conclusionCombined LDN+tDCS has possible benefits in reducing pain frequency and intensity; however, a placebo effect was observed in pain using VAS, and further studies should be performed to analyze the possible association.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.