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Table 2 Scheduled measurements of primary and secondary outcomes

From: Effectiveness of intramuscular gluteal glucocorticoid injection versus intra-articular glucocorticoid injection in knee osteoarthritis: design of a multicenter randomized, 24 weeks comparative parallel-group trial

Measurement

Baseline

Injection

2 weeks fu

4 weeks fu

8 weeks fu

12 weeks fu

24 weeks fu

Primary outcome measure

 KOOS pain subscale

x

 

x

x

x

x

x

Secondary outcome measures

 Adverse events

  

x

    

 Hospitalization

  

x

x

x

x

x

 Co-interventions (iMCQ)

  

x

x

x

x

x

 Medication use for knee OA

x

 

x

x

x

x

x

 Re-injection with glucocorticoid

    

x

x

x

 KOOS stiffness

x

 

x

x

x

x

x

 KOOS function in daily living

x

 

x

x

x

x

x

 KOOS sports and recreation

x

 

x

x

x

x

x

 KOOS QoL

x

 

x

x

x

x

x

 ICOAP

x

 

x

x

x

x

x

 OMERACT OARSI responder criteria

  

x

x

x

x

x

 Knee pain over past week (NRS)

x

x

x

x

x

x

x

 Perceived recovery (Likert scale)

  

x

x

x

x

x

 Knee complaint characteristics

x

 

x

x

x

x

x

 Health related QoL

x

      

Additional measurements

 Radiograph of study knee

     

x

 

 Check of ACR criteria

 

x

     

 Painfulness of injection (NRS)

  

x

    

 Demographic information

x

      

 Co-morbidity

x

      

 Physical activity over the past week (IPAQ short)

x

      

 Neuropathic pain (Modified painDETECT Questionnaire)

x

      

 Patients’ preferred injection site

x

      

 Patients’ expected treatment response

x

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