Verslagen

Voortgangsverslag

Samenvatting
Dit item is dichtgeklapt
Dit item is opengeklapt

Huisartsen behandelen veel patiënten met knieartrose. Deze studie onderzoekt de effectiviteit van een corticosteroïd injectie in het kniegewricht (volgens de richtlijn) ten opzichte van een corticosteroïd injectie in de bilspier (experimenteel).

 

Hiervoor zullen we minimaal 140 patiënten met kneiartrose met behulp van loting toewijzen aan twee behandelgroepen: 1.

Corticosteroïd injectie in het kniegewricht, 2. Corticosteroïd injectie in de bil. De uitkomst is de ernst van de kniepijn op 4 weken na de beginmeting.

 

De patiënten worden 24 weken vervolgd om ook het langer termijn effect in kaart te brengen.

Resultaten
Dit item is dichtgeklapt
Dit item is opengeklapt

Er zijn bijna 100 patiënten geïncludeerd in de trail. Er wordt hard gewerkt aan de werving van de resterende 40 patiënten.

 

Het design van de studie is gepresenteerd middels een posterpresentatie op het World Congress on Osteoarthritis 2018 (Mol et al. Osteoarthritis Cartilage 2018, Volume 26, Supplement 1, Page S277).

Samenvatting van de aanvraag

Samenvatting
Dit item is dichtgeklapt
Dit item is opengeklapt

BACKGROUND

In the Netherlands knee osteoarthritis is mainly managed by general practitioners. If patients are not responding satisfactorily to analgesics (paracetamol and/or NSAID) for their knee pain, an intra-articular corticosteroid injection is recommended. However, the effectiveness of an intra-articular injection compared to normal daily care without an intra-articular injection is unclear. In addition, it is unknown if an intra-muscular gluteal corticosteroid injection is non-inferior to an intra-articular injection.

 

OBJECTIVES

In this study we will address in patients with knee osteoarthritis:

1) the effectiveness of an intra-articular corticosteroid injection compared to normal daily care with no injection on knee pain at 4 weeks follow-up in general practice,

2) the non-inferiority of an intra-muscular gluteal corticosteroid injection compared to an intra-articular corticosteroid injection on knee pain at 4 weeks follow-up in general practice.

 

STUDY DESIGN

The study design is a pragmatic, multicenter, 3 parallel group, randomized controlled trial with a total follow-up of 24 weeks.

 

PATIENTS

Patients (n=159) will be recruited from general practices. Patients with knee osteoarthritis who contacted their general practitioner (consultation and/or repeat pain medication prescription) in the past year will be screened on knee pain severity. If reported knee pain severity is 4 or higher on a 0-10 scale (0=no knee pain) and a corticosteroid injection is not contra-indicated, patients will be invited to participate in the trial.

 

INTERVENTIONS

Patients will be randomly allocated to one of the three treatment groups:

 

1) patients (n=53) that will receive usual care by their general practitioner and an intra-muscular gluteal injection with 40 mg triamcinolone acetate,

2) patients (n=53) receiving usual care by their general practitioner including an intra-articular knee injection with 40 mg triamcinolone acetate, or

3) patients (n=53) receiving usual care except injections by their general practitioner.

 

OUTCOMES

Patients will fill in questionnaires at baseline and at 4, 8, 12 and 24 weeks follow-up. The primary outcome for both objectives will be the severity of knee pain measured with Knee injury and Osteoarthritis Outcome Score (KOOS) pain. Secondary outcomes are patients’ reported adverse events, disability, co-interventions, knee pain severity over the last week, global osteoarthritis pain using the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain, intermittent and constant osteoarthritis pain, quality of life, patients’ perceived recovery, and the percentage of responders as defined by the OMERACT-OARSI criteria.

 

STATISTICAL ANALYSES

For statistical clinical effectiveness the data analysis will be performed based on the intention-to-treat principle using linear mixed models with repeated measures.

Regarding non-inferiority of an intra-muscular injection data analysis will also be based on a per protocol analyses using those patients who actually received the allocated injection and reported outcomes at 4 weeks follow-up.

 

FEASIBILITY

This study is highly feasible because eligible (prevalent) patients with knee osteoarthritis can be invited to participate in the trial by searching the electronic medical files of the general practices.

 

TIME SCHEDULE

We aim to recruit an aiotho (general practitioner trainee and PhD traject); total duration 72 months which includes 36 months research:

- 6 months clinical epidemiology courses (NIHES).

- 3 months teaching.

- 3 months preparation trial/recruiting general practitioners.

- 15 months inclusion of patients.

- 6 months follow-up measurements.

- 2 months analysis and reporting.

- 1 months preparation thesis.

 

Naar boven
Direct naar: InhoudDirect naar: NavigatieDirect naar: Onderkant website