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Table 2 Schedule of assessment and data collection

From: Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): study protocol for a randomized controlled trial

 

Screening visit

Allocation

Post allocation

Time point

Up to 4 weeks before BL

0

Baseline visit (BL)

Week 1

Week 4

Week 16 (end)

Enrolment:

      

 Eligibility screening

x

     

 Informed consent

x

     

 Screening knee X-ray

x

     

 Screening blood test *

x

     

 Physical Examination

x

 

x

x

x

x

Interventions:

      

 Colchicine 0.5 mg bid

  

Start here

  

End here

 Placebo 1 tablet bid

  

Start here

  

End here

Assessments:

      

 Physical Examination

x

 

x

x

x

x

 Full blood count

x

    

x

 Renal function test

x

  

x

x

x

 Liver function test

x

  

x

x

x

 Uric acid

x

  

x

x

x

 CPK

x

  

x

x

x

 βHCG (for women with child bearing potential)

x

     

 Blood biomarkers collection

  

x

x

x

x

 Urine biomarkers collection

  

x

x

x

x

 Blood for pharmcogenomic

  

x

   

 Colchicine level

  

x

x

x

x

 Both knees aspiration

  

x

  

x

 Knee X-ray (both sides)

x

     

 MRI of signal knee ǂ (for 20 subjects only)

 

x

    

 Adverse event enquiries

  

x

x

x

x

 Enquiries to compliance to usual medications for knee

  

x

x

x

x

 Clinical data collection

  

x

  

x

 Pain score enquiries (signal knee)

  

x

x

x

x

 Demographic data collection

  

x

   

 WOMAC

  

x

  

x

 HAQ

  

x

  

x

 SF36v2

  

x

  

x

  1. *(FBC, renal function, liver function, uric acid, CPK, βHCG for women with child bearing potential); ǂ: For ten colchicine treated and ten placebo treated participates, randomly assigned; CPK, creatine phosphokinase; βHCG, β-human chorionic gonadotropin; MRI, magnetic resonance imaging; X-ray, radiography; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index; HAQ, Health Assessment Questionnaire; SF36v2, Medical Outcome Short Form 36 version 2.