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• W4205120949 abstract "There is evidence that low-dose naltrexone (LDN; <5.0 mg/day) reduces pain and improves the quality of life of people with fibromyalgia syndrome (FMS). However, no randomised controlled trials with long-term follow-ups have been carried out. The INNOVA study will evaluate the add-on efficacy, safety, cost-utility and neurobiological effects of LDN for reducing pain in patients with FMS, with a 1-year follow-up.A single-site, prospective, randomised, double-blinded, placebo-controlled, parallel design phase III trial will be performed. Eligibility criteria include being adult, having a diagnosis of FMS and experiencing pain of 4 or higher on a 10-point numerical rating scale. Participants will be randomised to a LDN intervention group (4.5 mg/day) or to a placebo control group. Clinical assessments will be performed at baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3). The primary endpoint will be pain intensity. A sample size of 60 patients per study arm (120 in total), as calculated prior to recruitment for sufficient power, will be monitored between January 2022 and August 2024. Assessment will also include daily ecological momentary evaluations of FMS-related symptoms (eg, pain intensity, fatigue and sleep disturbance), and side effects via ecological momentary assessment through the Pain Monitor app during the first 3 months. Costs and quality-adjusted life years will be also calculated. Half of the participants in each arm will be scanned with MRI at T0 and T1 for changes in brain metabolites related to neuroinflammation and central sensitisation. Inflammatory biomarkers in serum will also be measured.This study has been approved by the Ethics Committee of the Fundació Sant Joan de Déu. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and community engagement activities.NCT04739995." @default.
• W4205120949 created "2022-01-25" @default.
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• W4205120949 date "2022-01-01" @default.
• W4205120949 modified "2023-10-17" @default.
• W4205120949 title "Study protocol for a randomised, double-blinded, placebo-controlled phase III trial examining the add-on efficacy, cost–utility and neurobiological effects of low-dose naltrexone (LDN) in patients with fibromyalgia (INNOVA study)" @default.
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• W4205120949 cites W134978157 @default.
• W4205120949 cites W1489805892 @default.
• W4205120949 cites W1774387537 @default.
• W4205120949 cites W1966141303 @default.
• W4205120949 cites W1972958276 @default.
• W4205120949 cites W1984832858 @default.
• W4205120949 cites W1990166011 @default.
• W4205120949 cites W1994291650 @default.
• W4205120949 cites W1995240652 @default.
• W4205120949 cites W1996076624 @default.
• W4205120949 cites W2003982930 @default.
• W4205120949 cites W2006188470 @default.
• W4205120949 cites W2011924447 @default.
• W4205120949 cites W2031045752 @default.
• W4205120949 cites W2032867586 @default.
• W4205120949 cites W2036091553 @default.
• W4205120949 cites W2042116454 @default.
• W4205120949 cites W2043705607 @default.
• W4205120949 cites W2059396054 @default.
• W4205120949 cites W2064839369 @default.
• W4205120949 cites W2067267561 @default.
• W4205120949 cites W2084982638 @default.
• W4205120949 cites W2086096448 @default.
• W4205120949 cites W2097771779 @default.
• W4205120949 cites W2100251061 @default.
• W4205120949 cites W2106231605 @default.
• W4205120949 cites W2108696783 @default.
• W4205120949 cites W2116230226 @default.
• W4205120949 cites W2124355299 @default.
• W4205120949 cites W2126241051 @default.
• W4205120949 cites W2133311262 @default.
• W4205120949 cites W2134557769 @default.
• W4205120949 cites W2141674457 @default.
• W4205120949 cites W2141845857 @default.
• W4205120949 cites W2142829723 @default.
• W4205120949 cites W2149444223 @default.
• W4205120949 cites W2153024655 @default.
• W4205120949 cites W2159431069 @default.
• W4205120949 cites W2161344815 @default.
• W4205120949 cites W2165305033 @default.
• W4205120949 cites W2166023752 @default.
• W4205120949 cites W2412927822 @default.
• W4205120949 cites W2501112626 @default.
• W4205120949 cites W2516246660 @default.
• W4205120949 cites W2519381186 @default.
• W4205120949 cites W2564020641 @default.
• W4205120949 cites W2566335889 @default.
• W4205120949 cites W2592360091 @default.
• W4205120949 cites W2607401549 @default.
• W4205120949 cites W2609884869 @default.
• W4205120949 cites W2624514205 @default.
• W4205120949 cites W2791408187 @default.
• W4205120949 cites W2792368473 @default.
• W4205120949 cites W2802702029 @default.
• W4205120949 cites W2805154277 @default.
• W4205120949 cites W2891285073 @default.
• W4205120949 cites W2898459803 @default.
• W4205120949 cites W2905222826 @default.
• W4205120949 cites W2912081150 @default.
• W4205120949 cites W2997757166 @default.
• W4205120949 cites W2999787682 @default.
• W4205120949 cites W3007810039 @default.
• W4205120949 cites W3018877629 @default.
• W4205120949 cites W3022941230 @default.
• W4205120949 cites W3043207058 @default.
• W4205120949 cites W3080827468 @default.
• W4205120949 cites W3107075479 @default.
• W4205120949 cites W3131392010 @default.
• W4205120949 cites W3153697024 @default.
• W4205120949 cites W4211038282 @default.
• W4205120949 cites W4236805817 @default.
• W4205120949 cites W4245357914 @default.
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• W4205120949 doi "https://doi.org/10.1136/bmjopen-2021-055351" @default.
• W4205120949 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/34992118" @default.
• W4205120949 hasPublicationYear "2022" @default.
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