Schedule of enrolment, interventions and assessments
Timepoint | Study period | |||||||||||
Screening and eligibility | Allocation | Post allocation | Close-out | |||||||||
−T1 | 0 | T1 | T2 | T3 | D8–15 | T4 | T5 | T6 | T7 | T8 | T9 | |
D=day, W=week | D0 | D1 | D2–6 | D7 | D14 | D21 | W6 | W12 | W24 | W48 | ||
Enrolment | ||||||||||||
Eligibility screen | ✓ | ✓ | ||||||||||
Neurological and musculoskeletal examination | ✓ | ✓ | ||||||||||
Safety blood tests | ✓ | ✓ | ✓ | ✓ | ✓ | |||||||
MRI (or CT if MRI contraindicated or CT clearly demonstrates imaging pathology) | ✓ | |||||||||||
Oswestry Disability Index | ✓ | ✓ | ||||||||||
Informed consent | ✓ | |||||||||||
Allocation | ✓ | |||||||||||
Interventions | ||||||||||||
Procedural injection in radiology suite | X | |||||||||||
Oral medications | X | X | XXXX | X | XXXX XXXX | |||||||
Assessments | ||||||||||||
Outcome variables | ||||||||||||
Oswestry disability index | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Numerical pain rating scales | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Pain DETECT Questionnaire | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
SF-36 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
EQ-5D-5L | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Work/health utilisation/costs | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Medication history | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Neurological and musculoskeletal examination | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
Safety blood tests | ✓ | ✓ | ||||||||||
Other data variables | ||||||||||||
Rescue procedure history | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
Participation randomisation perception | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
Adverse events and serious adverse event assessment | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
SF-36, Short Form 36.