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Table 1 Schedule of assessments, KARAOKE study

From: KARAOKE: Krill oil versus placebo in the treatment of knee osteoarthritis: protocol for a randomised controlled trial

Visit/week number

Screening

Baseline (week 0)

4

8

12

16

20

24

Informed consent

x

       

Knee x-ray

x

       

Knee MRI

x*

      

x

Clinical measures

 Bloods

x

   

x

  

x

 Clinical examination

x

       

 Leg strength

 

x

  

x

  

x

 Height and weight

 

x

     

x

 Capsules given

 

x

  

x

   

 Capsule count

    

x

  

x

 Pressure pain testing (Melbourne/Perth only)

 

x

  

x

  

x

 Ultrasound (Perth)

 

x

     

x

Questionnaire measures

   

 Knee VAS

x

x

x

x

x

x

x

x

 Knee WOMAC

 

x

x

x

x

x

x

x

 Knee ICOAP

 

x

x

x

x

x

x

x

 Patient global evaluation

 

x

x

x

x

x

x

x

 Joint replacement surgery

x

   

x

  

x

 Concomitant medications

x

   

x

  

x

 Safety (AEs)

    

x

  

x

 Hand VAS, back VAS

 

x

x

x

x

x

x

x

 AQoL

 

x

  

x

  

x

 Patient health questionnaire (PHQ-9)

 

x

      

 Pain at other sites

 

x

  

x

  

x

 Treatment guessing

    

x

  

x

 painDETECT

 

x

      

 Adverse events

As required

 Early withdrawal

As required

  1. *if otherwise suitable