Skip to main content

Table 1 Timetable and measures to be made

From: Can low-dose methotrexate reduce effusion-synovitis and symptoms in patients with mid- to late-stage knee osteoarthritis? Study protocol for a randomised, double-blind, and placebo-controlled trial

 

Screening

Weeks

Withdraw

0

4

12

24

36

52

Primary outcomes

 MRI (effusion-synovitis volume)

✔

     

✔

✔

 Knee pain (VAS)

✔

 

✔

✔

✔

✔

✔

✔

Secondary outcomes

 MRI (IPFP intensity alteration)

✔

     

✔

✔

 WOMAC

✔

 

✔

✔

✔

✔

✔

✔

Other measures

 Medical history

✔

       

 Clinical assessment

✔

       

 MRI (effusion-synovitis score)

✔

     

✔

✔

 X-ray (knee)

✔

       

 X-ray (lung)*

✔

       

 Blood tests

✔

 

✔

✔

✔

✔

✔

✔

 General health status (VAS)

✔

 

✔

✔

✔

✔

✔

✔

 SF-12

✔

 

✔

✔

✔

✔

✔

✔

 PHQ-9

✔

 

✔

✔

✔

✔

✔

✔

 Weight/height

✔

       

 Waist/hip circumference

✔

       

 Medication

 

✔

✔

✔

✔

✔

✔

✔

 Tablet number

 

✔

✔

✔

✔

✔

✔

✔

 Adverse event

 

✔

✔

✔

✔

✔

✔

✔

  1. *Up to the principal investigators to decide if necessary