Management of acromioclavicular joint disease by manual therapy versus corticosteroid injections: the protocol of a non-inferiority study.

INTRODUCTION: Degenerative acromioclavicular joint pain accounts for about 4% of shoulder pain. Various medical and non-medical treatment strategies are available for acromioclavicular joint disease but it is difficult to conduct a comparative evaluation of these treatments. The few studies dealing with the medical management of the disease have conducted no comparative assessment of drug therapies, physiotherapy, joint manipulation and corticosteroid injections. The primary goal of this study is to determine whether manual therapy is not inferior to ultrasound-guided injection of a corticosteroid preparation to decrease acromiocalvicular joint pain at 3 months. METHODS AND ANALYSIS: The acromioclavicular arthropathy managed by manual therapy is a monocentric, comparative, randomised, controlled, non-inferiority study conducted in the Rheumatology Department of Vendée Departmental Hospital, involving two parallel groups receiving either corticosteroid injections or manual therapy. The inclusion criteria are patients who suffer from pain in the shoulder or the proximal part of the arm, with pain located on palpation of the acromioclavicular joint associated with a positive cross-arm test and a positive O'Brien test. Randomisation will be at a 1:1 ratio. The injection group will receive a single ultrasound-guided injection of 1 mL of Diprostène and the manual therapy group will receive between one and three sessions at intervals of one per week. The primary outcome will be to compare the Visual Analogue Scale for pain-activity-related score at 3 months for both groups. ETHICS AND DISSEMINATION: The study project has been approved by the appropriate ethics committee (Committee for the Protection of Patients Ouest II in Angers, 30 April 2019, with the registration number of 2019/22). In agreement with current French regulations, signed informed written consent will be obtained from each patient. Results of the main trial and of the secondary endpoints will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT03951480.

Corticosteroids injections versus corticosteroids with hyaluronic acid injections in rhizarthrosis: the randomised multicentre RHIZ'ART trial study protocol.

INTRODUCTION: Osteoarthritis of the trapeziometacarpal joint affects approximately 10%-25% of women, especially those who are postmenopausal. It may result in thumb dysfunction. Among the treatments, intra-articular injections of corticosteroid (CS) and hyaluronic acid (HA) are both effective and recommended. However, clinical trials have shown that HA improves functional capacity, whereas CS only produces a decrease in pain. The synergy of these two drugs has not been evaluated. The primary goal of this study was to determine whether the association between HA and CS produce an additional decrease of more pain during thumb movement at three months postinjection, compared to the level of pain relief from CS alone. METHODS AND ANALYSIS: RHIZ'ART is a prospective, multicentre, comparative, randomised, controlled, double-blind trial. Patients referred to the rheumatology department for thumb rhizarthrosis will receive an injection of betamethasone with HA or placebo (serum saline) based on central randomisation and stratification by centre. Injections will be given under ultrasound guidance. The primary outcome will compare the pain Visual Analogue Scale with motion at three months for both groups using a mixed model. The expected decrease in pain intensity in the CS group is 25% and 35% in the CS with HA group. In order to achieve a 80% power for detecting this difference with α set at 5%, 73 patients are needed in each group (146 total). The main secondary outcomes are the Cochin score (hand function) and grip strength. Follow-up visits are at 1, 3, 6 and 12 months. ETHICS AND DISSEMINATION: The study project has been approved by the appropriate ethics committee (CPP île de France III, 2017-002298-20). In agreement with current French regulations, a signed informed written consent will be obtained from each patient. Results of the main trial and of the secondary endpoints will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT03431584.

Impact of rotavirus vaccination on hospitalizations for rotavirus diarrhea: the IVANHOE study.

The aim of the IVANHOE study was to determine the real-world impact of the rotavirus vaccine, controlling for epidemic-to-epidemic variation in disease burden. A population-based prospective cohort study was conducted in Brest City and 7 suburban districts (CUB area), North-western Brittany, France (210,000 inhabitants; 5500 births per year). The vaccination program started in May 2007 for a 2-year period for all infants born in the Brest birth zone through pediatricians, public outpatient clinics and general practitioners. To determine vaccine impact we monitored trends in hospitalizations for rotavirus-specific diarrhea using an active hospital-based surveillance system initiated 5 years before vaccine introduction. The number of hospitalizations for rotavirus-specific diarrhea during the 2008/2009 epidemic in infants less than 2 years of age whose parents lived within the CUB area was modelled as a function of (1) the number of hospitalizations in infants 2-5 years of age to control for epidemic-to-epidemic variation and (2) vaccine introduction. A total of 4684 infants received at least one dose. Of these, 2635 lived within the CUB area. Vaccine coverage for a complete schedule in the CUB area was 47.1%. Poisson modelling revealed a reduction by a factor of 2.04 (1.56-2.66) in the number of hospitalizations during the last epidemic season (2008/2009), the number of observed cases being equal to 30, against an expected number of 61. Relative risk reduction for hospitalizations for rotavirus diarrhea was 98% (95% CI: 83-100%). We observed a noticeable impact of vaccination on rotavirus diarrhea hospitalizations within 2 years of vaccine introduction integrating for the first time rotavirus epidemics variation. The trial is registered with ClinicalTrials.gov, number, NCT00740935.