Overview of the outcome measurements at each study visit for DETECT
Outcome measurements | Evaluation tool | Baseline screening | DTM SCS | ||
V0 | V1 (1 month) | V2 (6 months) | V3 (12 months) | ||
Overall pain | VAS | X | X | X | X |
Leg pain intensity | VAS | X | X | X | X |
Back pain intensity | VAS | X | X | X | X |
Disability | ODI | X | X | X | X |
Medication use | MQS III | X | X | X | X |
Quality of life | EQ-5D-5L | X | X | X | X |
Impression of change | PGIC | X | X | X | |
Patient activation | PAM-13 | X | X | X | X |
Holistic responder status | Composite measure | X | X | X | |
Pain catastrophising | PCS | X | X | X | X |
Symptoms of central sensitisation | CSI | X | X | X | X |
Anxiety and depression | HADS | X | X | X | X |
Work status | Self-developed questionnaire | X | X | X | |
Patient expectations | Open question | X | |||
Healthcare utilisation | Patient reporting | X | X | X | |
Time spent in body postures | IPG output | X | X | X | |
(Serious) adverse events | Physician reporting | X | X | X | |
Proportion of successful DTM trials | X | ||||
DTM stimulation parameters | IPG output | X | X | X | |
Battery consumption/recharge frequency | Patient reporting | X | X | X | |
Prevalence of technical issues with DTM programming | Physician reporting | X | X | X |
CSI, Central Sensitization Inventory; DTM, differential target multiplexed; EQ-5D-5L, EuroQol with five dimensions and five levels; HADS, Hospital Anxiety and Depression Scale; IPG, implantable pulse generators; MQS III, Medication Quantification Scale III; MQS ODI, Oswestry disability index; PAM-13, Patient Activation Measure-13; PCS, Pain Catastrophizing Scale; PGIC, Patient Global Impression of Change Scale; SCS, spinal cord stimulation; V, visit; VAS, visual analogue scale.