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. 2022 Sep 19;12(9):e063613. doi: 10.1136/bmjopen-2022-063613

Table 2.

Schedule of assessments

Assessment Screen Baseline scan Week 1 Week 2 Week 3 Post-Tx scan (Week 4) Week 6
Eligibility and safety assessments Consent form x
Characterisation of pain x
Physical examination x
Medical history x
Concomitant medications x x
Adverse events x x x x x x
C-SSRS (suicidality) x x x x x
Urine drug test (10-Panel) x x x
Urine pregnancy test x
Serum pregnancy test x x
Liver function tests x x
Primary outcome [11C]PBR28 Signal in Thalamus x x
Secondary outcomes [11C]PBR28 Signal in Limbic Regions (pgACC, aMCC) x x
‘Worst Pain’ item of BPI-SF (0–10 scale) Daily survey ratings from~2 weeks before scan I until Week 6
Pain Bothersomeness Ratings (0–10 scale) Daily survey ratings from~2 weeks before scan I until Week 6
BDI-II x x x x
PGIC x
Exploratory outcomes Reward Task (MID) x x
BPI-SF x x x x
PCS x x x x
PainDETECT x x
ODI x x
ACR Fibromyalgia Survey x x x
Depression Ratings (0–10 scale) Daily survey ratings from~2 weeks before scan I until week 6
PROMIS-29 x x
PSQI x x x
SymptomMapper x x

BDI-II, Beck Depression Inventory; BPI-SF, Brief Pain Inventory-Short Form; MID, Monetary Incentive Delay Task; ODI, Oswestry Disability Index; PCS, Pain Catastrophizing Scale; PGIC, Patient Global Impression of Change; PROMIS-29, Patient Reported Outcomes Measurement Information System–29; PSQI, Pittsburgh Sleep Quality Index.