Footwear for self-managing knee osteoarthritis symptoms: protocol for the Footstep randomised controlled trial.

BACKGROUND: Knee osteoarthritis (OA) is a leading cause of musculoskeletal pain and disability globally, and abnormal knee loading is central to disease pathogenesis. Clinical guidelines recommend clinicians provide advice regarding appropriate footwear for people with knee OA, yet there is little research comparing the effects of different footwear on knee OA symptoms. Research suggests that wearing flat flexible shoes is associated with lower knee joint loads compared to stable supportive shoe styles. This two-arm pragmatic, comparative effectiveness randomised controlled trial will compare the effects of daily use of flat flexible shoes and stable supportive shoes on knee OA clinical outcomes, over 6 months. METHODS: 164 people with symptomatic medial tibiofemoral OA of moderate to severe radiographic severity (Kellgren and Lawrence Grade 3 & 4) will be recruited from the community. Following baseline assessment, participants will be randomly allocated to receive either i) flat flexible shoes or; ii) stable supportive shoes. Participants will choose two different pairs of shoes from a selection that fulfil the criteria in their allocated shoe class. Limited disclosure will blind participants to group allocation. Participants will be instructed to wear their allocated shoes daily for 6 months (minimum of 6 h/day), after which participants will be reassessed. The primary outcomes are knee pain severity on walking (measured by numerical rating scale) and self-reported physical function (measured by the Western Ontario and McMaster Universities Osteoarthritis Index), assessed at baseline and 6 months. Secondary outcomes include additional measures of knee pain, function, sport and recreation participation and quality-of-life (measured using subscales of the Knee Osteoarthritis Outcome Score), as well as pain at other sites (measured by numerical rating scale), self-reported global ratings of change in pain and physical function (measured by 7-point rating scale), and physical activity levels (measured by Physical Activity Scale for the Elderly). DISCUSSION: This study will determine whether daily wear of flat flexible shoes improves clinical outcomes in the management of knee OA, compared to stable supportive shoes. Findings will assist clinicians in providing evidence-based advice regarding appropriate footwear for people with knee OA to self-manage symptoms. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN12617001098325 . Registered 28/07/2017.

Efficacy of intra-articular injections of platelet-rich plasma as a symptom- and disease-modifying treatment for knee osteoarthritis - the RESTORE trial protocol.

BACKGROUND: Knee osteoarthritis (OA) causes substantial pain, physical dysfunction and impaired quality of life. There is no cure for knee OA, and for some people, the disease may involve progressive symptomatic and structural deterioration over time. Platelet-rich plasma (PRP) is a therapeutic agent that aims to address underlying biological processes responsible for OA pathogenesis. As such, it has the potential to improve both symptoms and joint structure. The aim of this clinical trial is to determine whether a series of injections of PRP into the knee joint will lead to a significantly greater reduction in knee pain, and less loss of medial tibial cartilage volume over 12 months when compared to a series of placebo saline injections in people with knee OA. METHODS: This will be a two-group, superiority, randomised, participant-, interventionist- and assessor-blinded, placebo-controlled trial. Two hundred and eighty-eight participants aged over 50 years with painful knee OA and mild to moderate structural change on x-ray (Kellgren and Lawrence grade 2 and 3) will be randomly allocated to receive either three PRP injections or three normal saline injections into the knee joint at weekly intervals. The primary outcomes will be 12-month change in average overall knee pain severity (numeric rating scale) and medial tibial cartilage volume (magnetic resonance imaging (MRI)). Secondary outcomes include additional measures of knee pain and other symptoms, function in daily living and sport and recreation, quality of life, participant-perceived global ratings of change, and other MRI structural outcomes including meniscal and cartilage morphology, synovitis, effusion, bone marrow lesions and cartilage defects. A range of additional measures will be recorded, and a separate health economic evaluation will be performed. DISCUSSION: The findings from this study will help determine whether PRP improves both clinical and structural knee OA outcomes over 12 months when compared to a series of placebo saline injections. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN12617000853347 . Prospectively registered 9th of June 2017.