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)
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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)Autoria
Data de publicació
2022-01Editor
BMJ Publishing GroupISSN
2044-6055Cita bibliogràfica
Colomer-Carbonell A, Sanabria-Mazo JP, Hernández-Negrín H, et alStudy 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)BMJ Open 2022;12:e055351. doi: 10.1136/bmjopen-2021-055351Tipus de document
info:eu-repo/semantics/articleVersió de l'editorial
https://bmjopen.bmj.com/content/12/1/e055351Versió
info:eu-repo/semantics/publishedVersionParaules clau / Matèries
Resum
Introduction: 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 ... [+]
Introduction: 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.
Methods and analysis: 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.
Ethics and dissemination: 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. [-]
Publicat a
BMJ open, 2022, vol. 12, no 1Entitat finançadora
Instituto de Salud Carlos III | Agència de Gestió d'Ajuts Universitaris i de Recerca (AGAUR) | Serra Húnter program
Codi del projecte o subvenció
ICI20/00080 | CPII19/00003 | FI20/00034 | FI_B/00216 | UAB-LE-8015
Drets d'accés
info:eu-repo/semantics/openAccess
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