Skip to main content

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.