The FiREwORK trial - self-management with FootweaR combined with Exercise for OsteoaRthritis (OA) at the Knee: a phase II randomized controlled trial (FiREwORK)

Knee OA is an important cause of disability worldwide. No effective cure exists and many patients

will eventually undergo costly joint replacement. Clinical guidelines emphasize that non-drug nonsurgical

treatment should constitute first-line treatment. Exercise therapy is strongly recommended

for knee OA. However, overall treatment effects on symptoms are modest at best, which is further

compounded by poor adherence in the longer-term. In many patients the disease is also driven by

local knee inflammation. Muscle strengthening and aerobic exercise likely have anti-inflammatory

effects. However, pain and joint swelling further impair muscle function. Thus, in patients with

clinical signs of inflammation beneficial effects of exercise therapy may have been attenuated in

previous research. We suggest that adding adequate knee offloading through daily use of flat

flexible shoes, to exercise may help attenuate inflammatory responses from daily walking gait, and

thus, improve short- and long-term treatment effects from concurrent exercise therapy leading to

more effective symptom- and structure modification. In this phase II clinical trial, we will compare

clinical symptoms, markers of inflammation and structural disease progression in knee OA patients

with clinical inflammation who will undergo aerobic and strengthening exercise, added with daily

use of flat flexible shoes, or a conventional walking shoe. Conservative treatment & selfmanagement

are research priorities in OA.