Evidence map›Paper›PMID 40214857›Full record

Trial reportCNS drugs2025

Effect of Naltrexone on Spinal and Supraspinal Pain Mechanisms and Functional Capacity in Women with Fibromyalgia: Exploratory Outcomes from the Randomized Placebo-Controlled FINAL Trial.

Karin Due Bruun, Robin Christensen, Kirstine Amris, Morten Rune Blichfeldt-Eckhardt, Lars Bye-Møller, Marius Henriksen, Tine Alkjaer, Palle Toft, Anders Holsgaard-Larsen, Henrik Bjarke Vaegter

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in CNS drugs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Progress in mechanisms and therapy for fibromyalgia.Nature reviews. Rheumatology · 2026
    Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Karin Due BruunPain Research Group, Pain Center, Odense University Hospital, Heden 9, 5000, Odense C, Denmark. karin.due.bruun@rsyd.dk.ORCID 0000-0002-3106-2461
Robin ChristensenResearch Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark.ORCID 0000-0002-6600-0631
Kirstine AmrisThe Parker Institute, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark.ORCID 0000-0003-0792-505X
Morten Rune Blichfeldt-EckhardtPain Center Middelfart, Department of Anesthesia, Lillebaelt Hospital, University Hospital of Southern Denmark, Odense, Denmark.ORCID 0000-0002-7759-5642
Lars Bye-MøllerPatient Panel, Pain Center, Odense University Hospital, Odense, Denmark.
Marius HenriksenThe Parker Institute, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark.ORCID 0000-0003-1091-2962
Tine AlkjaerThe Parker Institute, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark.ORCID 0000-0002-9105-3882
Palle ToftDepartment of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.ORCID 0000-0002-3188-449X
Anders Holsgaard-LarsenDepartment of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.ORCID 0000-0003-4106-6930
Henrik Bjarke VaegterPain Research Group, Pain Center, Odense University Hospital, Heden 9, 5000, Odense C, Denmark.ORCID 0000-0002-7707-9947

Funding

Aase og Ejnar Danielsens Fond 21-10-0037Gigtforeningen A6158Odense Universitetshospital A3650
6 · The paper itself

Abstract

backgroundThe widespread pain and muscular fatigue characteristics of fibromyalgia are believed to be mediated by central mechanisms. Low-dose naltrexone (LDN) has emerged as a new treatment option for fibromyalgia, possibly modulating central mechanisms via glial or opioid receptors.

methodsIn the randomized, placebo-controlled FINAL trial, 99 women with fibromyalgia were treated with LDN or placebo for 12 weeks. In this secondary analysis, we examined the potential effects of LDN versus placebo on changes from baseline in pain tolerance, temporal summation of pain, and conditioned pain modulation (CPM) in the complete case population (45 versus 47 participants). Measures of muscular fatigue were evaluated using the 30-s chair stand test and a shoulder abduction test.

resultsOf the five examined outcomes, only change in CPM showed a significant between-group difference with greater enhancement following LDN treatment (2.0 kPa; 95% confidence interval (CI) 0.4-3.7 kPa) compared with placebo. Within-group changes in CPM showed an increase of 1.2 kPa (95% CI 0.05-2.4 kPa) in the LDN group and a possible decrease of 0.8 kPa (95% CI - 1.9 to 0.4 kPa) in the placebo group.

conclusionsWe found a significant between-group difference in CPM change in favor of LDN. However, this difference was partly explained by a decrease in CPM in the placebo group. Sensitivity analyses showed no association between changes in CPM and clinical pain improvement, suggesting that the group-difference in CPM is a random finding. STUDY REGISTRATION: ClinicalTrials.gov (NCT0427877; registered on 30 January 2020).

Indexed as

FibromyalgiaNaltrexoneNarcotic AntagonistsPainAdultDouble-Blind MethodFemaleHumansMiddle AgedPain MeasurementPain ThresholdTreatment OutcomeNaltrexoneNarcotic Antagonists

Identifiers

PMID40214857
PMCPMC12165890

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.