| Home > Articles > Published articles > 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) |
(Universitat Autònoma de Barcelona. Departament de Psicologia Bàsica, Evolutiva i de l'Educació) (Universitat Autònoma de Barcelona. Departament de Psicologia Bàsica, Evolutiva i de l'Educació) (Universitat Autònoma de Barcelona. Departament de Psicologia Bàsica, Evolutiva i de l'Educació) (Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición) (Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición) (Hospital Sant Joan de Déu (Manresa)) (London School of Economics and Political Science) (Chulalongkorn University) (Universitat Autònoma de Barcelona. Departament de Psicologia Clínica i de la Salut) (Universitat Autònoma de Barcelona. Departament de Psicologia Clínica i de la Salut)
| Date: | 2022 |
| 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. . |
| Grants: | Agència de Gestió d'Ajuts Universitaris i de Recerca FI_B/00216 Instituto de Salud Carlos III ICI20/00080 Instituto de Salud Carlos III FI20/00034 Instituto de Salud Carlos III CPII19/00003 |
| Note: | Altres ajuts: Serra Húnter program (UAB-LE-8015) |
| Rights: | Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.  |
| Language: | Anglès |
| Document: | Article ; recerca ; Versió publicada |
| Subject: | Pain management ; Health economics ; Clinical trials |
| Published in: | BMJ open, Vol. 12 (January 2022) , art. e055351, ISSN 2044-6055 |
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