Table 2

Spirit diagram of enrolment, interventions and assessments for the RADIANT study

Time pointsEnrolmentBaselineDay 1Postscheduling day 1
−t2−t10w1w2w3w4w5w6w7w8w9w10w11w12
Enrolment
Initial online screeningX
Hand X-ray referral*X
Hand photo screeningX
Radiographic screeningX
Eligibility assessmentX
Informed consentX
Medication washout*X
Treatment allocationX
Interventions
ActiveEmbedded Image
Placebo
Assessments
Primary outcome
VAS painXX
Secondary outcomes
AEsXXXXXXXXXXXX
VAS painXXX
FIHOAXXXX
PGA of disease activityXXXX
AQoL-4DXXXX
WPAI-GHXX
Other measures
Rescue medication useXXXXXXXXXXXX
Treatment adherenceXXXXXXXXXXXX
Capsule countX
Medication satisfactionX
Global rating of changeX
MPsQX
Computer self-efficacyX
Descriptive measures
Age, gender, BMI, symptom duration, X-ray severity, HOA phenotype, comorbidity, concomitant medicationX
  • *If applicable; −t3: the period between completion of online screening to signed consent form; −t2: washout period (if required); −t1: the period between baseline survey and the phone call scheduling day 1; w1–w12: week 1–12.

  • AEs, adverse events; AQoL-4D, assessment of quality of life four dimension; BMI, body mass index; FIHOA, Functional Index for Hand Osteoarthritis; HOA, hand osteoarthritis; MPsQ, Multidimensional Personality Questionnaire; PGA, patient global assessment; VAS, Visual Analogue Scale; WPAI-GH, Work Productivity and Activity Impairment Questionnaire General Health.