scholarly journals Efficacy and safety of short-term use of a pelubiprofen CR and aceclofenac in patients with symptomatic knee osteoarthritis: A double-blinded, randomized, multicenter, active drug comparative, parallel-group, phase IV, non-inferiority clinical trial

PLoS ONE ◽  
2020 ◽  
Vol 15 (9) ◽  
pp. e0238024
Author(s):  
Joung Youp Shin ◽  
Moon Jong Chang ◽  
Myung Ku Kim ◽  
Seung-Baik Kang ◽  
Kang-Il Kim ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Active Drug ◽  
Efficacy And Safety ◽  
Short Term ◽  
Parallel Group ◽  
Symptomatic Knee Osteoarthritis ◽  
Symptomatic Knee ◽  
Double Blinded ◽  
Phase Iv

scholarly journals Clinical and cost-effectiveness of bracing in symptomatic knee osteoarthritis management: protocol for a multicentre, primary care, randomised, parallel-group, superiority trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e048196
Author(s):  
Melanie A Holden ◽  
Michael Callaghan ◽  
David Felson ◽  
Fraser Birrell ◽  
Elaine Nicholls ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Analysis Of Covariance ◽  
Written Information ◽  
Parallel Group ◽  
Management Protocol ◽  
Adherence Support ◽  
Symptomatic Knee Osteoarthritis ◽  
Symptomatic Knee

BackgroundBrace effectiveness for knee osteoarthritis (OA) remains unclear and international guidelines offer conflicting recommendations. Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients’ clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists.Methods and analysisA multicentre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions.Ethics and disseminationNorth West Preston Research Ethics Committee, the Health Research Authority and Health and Care Research in Wales approved the study (REC Reference: 19/NW/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders.Trial registration numberISRCTN28555470.

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