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Platelet-Rich plasma Injection Management for Ankle osteoarthritis study (PRIMA): protocol of a Dutch multicentre, stratified, block-randomised, double-blind, placebo-controlled trial

Por: Paget · L. · Bierma-Zeinstra · S. · Goedegebuure · S. · Kerkhoffs · G. · Krips · R. · Maas · M. · Moen · M. · Reurink · G. · Stufkens · S. · de Vos · R. · Weir · A. · Tol · J.
Introduction

Platelet-rich plasma (PRP) is a potentially efficacious treatment for ankle osteoarthritis (OA), but its use has not been examined in high-quality studies. Systematic reviews show that PRP injections significantly decrease pain and improve function in patients with knee OA. Ankle OA is more common than hip or knee OA in the young active population; with a prevalence of 3.4%.

PRP injections in ankle OA are shown to be safe and improve quality of life over time, but no randomised controlled trial has been conducted. Our randomised controlled trial will evaluate the efficacy of PRP injections for symptom reduction and functional improvement, compared with placebo, in the treatment of ankle (talocrural) OA.

Methods and analysis

We will conduct the Platelet-Rich plasma Injection Management for Ankle OA study: a multicentre, randomised, placebo-controlled trial. One hundred patients suffering from ankle OA will be randomised into two treatment groups: PRP injection or placebo (saline) injection. Both groups will receive two injections of PRP or placebo at an interval of 6 weeks. Primary outcome is the American Orthopaedic Foot and Ankle Society score at 26 weeks. Secondary outcomes determined at several follow-up moments up to 5 years, include Ankle Osteoarthritis Score, Foot and Ankle Outcome Score, pain subscale of (0–40), Visual Analogue Scale score (0–100), Ankle Activity Score (0–10), subjective patient satisfaction Short Form Health Survey-36, Global Attainment Scaling and the EuroQol-5 dimensions-3 levels utility score. A cost-effectiveness analysis will be performed at 1 year.

Ethics and dissemination

The study is approved by the Medical Ethics Review Committee Amsterdam Medical Center, the Netherlands (ABR 2018–042, approved 23 July 2018) and registered in the Netherlands trial register (NTR7261). Results and new knowledge will be disseminated through the Dutch Arthritis Association (ReumaNederland), Dutch patient federation, conferences and published in a scientific peer-reviewed journal.

Trial registration number

NTR7261.

Gut-directed hypnotherapy versus standard medical treatment for nausea in children with functional nausea or functional dyspepsia: protocol of a multicentre randomised trial

Por: Browne · P. D. · den Hollander · B. · Speksnijder · E. M. · van Wering · H. M. · Tjon a Ten · W. · George · E. K. · Groeneweg · M. · Bevers · N. · Wessels · M. M. S. · van den Berg · M. M. · Goede · J. · Teklenburg-Roord · S. T. A. · Frankenhuis · C. · Benninga · M. A. · Vlieger · A
Introduction

The treatment of chronic functional nausea or nausea due to functional dyspepsia in children is generally symptomatic. Moreover, these disorders pose a risk for worse psychosocial and health outcomes in children. Hypnotherapy (HT), by its ability to positively influence gastrointestinal and psychosocial functioning, may be an effective treatment for chronic nausea.

Methods and analysis

To test efficacy, this multicentre, parallel, randomised controlled, open label trial evaluates whether gut-directed HT is superior to standard medical treatment (SMT) for reducing nausea. The study will be conducted at eleven academic and non-academic hospitals across the Netherlands. A total of 100 children (8–18 years), fulfilling the Rome IV criteria for chronic idiopathic nausea or functional dyspepsia with prominent nausea, will be randomly allocated (1:1) to receive HT or SMT. Children allocated to the HT group will receive six sessions of HT during 3 months, while children allocated to the SMT group will receive six sessions of SMT+supportive therapy during the same period. The primary outcome will be the difference in the proportion of children with at least 50% reduction of nausea, compared with baseline at 12 months’ follow-up. Secondary outcomes include the changes in abdominal pain, dyspeptic symptoms, quality of life, anxiety, depression, school absences, parental absence of work, healthcare costs and adequate relief of symptoms, measured directly after treatment, 6 and 12 months’ follow-up. If HT proves effective for reducing nausea, it may become a new treatment strategy to treat children with chronic functional nausea or functional dyspepsia with prominent nausea.

Ethics and dissemination

Results of the study will be publicly disclosed to the public, without any restrictions, in peer-reviewed journal and international conferences. The study is approved by the Medical Research Ethics Committees United (MEC-U) in the Netherlands.

Trial registration number

NTR5814.

Protocol for systematic review and meta-analysis of sex hormones and diabetes risk in ageing men and women of African ancestry

Por: Kufe · N. C. · Masemola · M. · Chikowore · T. · Kengne · A. P. · Olsson · T. · Goedecke · J. H. · Micklesfield · L. K.
Aim

To present the protocol of a systematic review and meta-analysis of the available evidence examining the association between sex hormones and type 2 diabetes risk in ageing men and women of African descent.

Methods

We shall conduct a comprehensive search of published studies that examined the association between sex hormones and type 2 diabetes risk in men and women aged ≥40 years from 01/01/1980 to 31/03/2018 with no language restriction. Databases to be searched include: PubMed, Scopus, Cochrane Library, Cumulative Index to Nursing and Allied Health, ISI Web of Science, Clinical Trial registries, Google Scholar and institutional websites such as the WHO, American Diabetes Association, International Diabetes Federation, World Diabetes Foundation, European Association for the Study of Diabetes, African Journal Online and ProQuest databases. This protocol is developed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. Independent screening for eligible studies using defined criteria and data extraction, will be completed in duplicate. Discrepancies will be resolved by consensus or consultation with a third researcher. Risk of bias of included studies will be assessed by the appropriate Cochrane risk of bias tool. The overall association estimates will be pooled using appropriate meta-analytic techniques. Heterogeneity will be assessed using Cochrane Q statistic and the inconsistency index (I2). The random effects model will be used to calculate a pooled estimate.

Ethics and dissemination

No ethics clearance is required as no primary data will be collected. The systematic review and meta-analysis are part of a PhD project at WITS University (Johannesburg, South Africa) and results will be presented at conferences and published in a peer-review journal. The results will guide future population specific interventions.

PROSPERO registration number

CRD42017074581.

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