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Table 1 Trial schedule according to the recommendation for interventional trial (SPIRIT) guidelines

From: Arthroscopic synovectomy versus intra-articular injection of corticosteroids for the management of refractory psoriatic or rheumatoid arthritis of the wrist: study protocol for a randomized controlled trial (ARCTIC trial)

 

Enrolment

Allocation

Post-allocation

Timepoint**

14 days (± 4 days) prior to intervention

Intervention

Week 2

Week 4

Week 6

Month 3

Month 6

Month 12

Enrolment

 Eligibility screen

X

       

 Informed consent

X

       

 Allocation

X

       

Interventions

 Arthroscopic synovectomy

 

X

      

 Intra-articular corticosteroid injection

 

X

      

Assessments

 Questionnaires (PRWE, EQ-5D-5L, iMCQ, iPCQ)

X

    

X

X

X

 Physical exam (including ROM, GS and DAS28)

X

    

X

X

X

 Wrist ultrasound

X

    

X

  

 Plain wrist radiographs

X

      

X

 Blood parameters (ESR, CRP)

X

    

X

X

X

 NRS pain scores

X

 

X

X

X

X

X

X

 Complications and secondary treatment

  

X

X

X

X

X

X

 Cost-effectiveness analysis

       

X