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Table 7 Tertiary study endpoints

From: High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN)

• Difference between the treatment groups in the average percentage change from baseline in lower limb pain visual analog scale (VAS) scores at 3 and 6 months. Within-group evaluations will be carried out at 12 and 24 months.

• Difference between the treatment groups in proportion of subjects with at least 30% improvement in lower limb pain VAS at 3 and 6 months. Within-group evaluations will be carried out at 12 and 24 months.

• Within-group evaluation of proportion of remitters at 12 and 24 months.

• Within-group evaluation of responder rates at 12 and 24 months.

• Within-group evaluation of proportion of subjects with improvement from baseline in neurological assessment (motor, sensory, or reflex) at 12 and 24 months.

• Difference between the treatment groups in numbers needed to treat (NNTs) based on responder rates at 3 and 6 months. Within-group evaluations will be carried out at 12 and 24 months.

• Difference between the treatment groups in average percentage change from baseline in opioid dosage at 3 and 6 months. Within-group evaluations will be carried out at 12 and 24 months.

• Difference between the treatment groups in average percentage change from baseline in painful diabetic neuropathy–specific analgesic dosages at 3 and 6 months. Within-group evaluations will be carried out at 12 and 24 months.

• Difference between the treatment groups in average percentage change from baseline in hemoglobin A1c (HbA1c) levels at 3 months. Within-group evaluation will be carried out at 12 and 24 months.

• Difference between the treatment groups in average percentage change from baseline in diabetic control medication dosages at 3 and 6 months. Within-group evaluations will be carried out at 12 and 24 months.

• Difference between the treatment groups in average percentage change from baseline in body mass index at 3 and 6 months. Within-group evaluations will be carried out at 12 and 24 months.

• Difference between the treatment groups in the average percentage change from baseline on distance covered during the 6-minute walk test (6MWT) at 3 months. Within-group evaluations will be carried out at 12 and 24 months.

• Difference between the treatment groups in the change over time in size of lower limb wounds at 3 and 6 months. Within-group evaluations will be carried out at 12 and 24 months.

• Difference between the treatment groups at 3 and 6 months in health economic outcomes, including (1) health-care utilization (i.e., medications, office visits, emergency room visits, hospital admissions, medical tests, etc.), (2) employment status, and (3) health-related quality of life as assessed by the EuroQol Five Dimensions questionnaire (EQ-5D-5L) and the Diabetes Quality of Life (DQOL) measure. Within-group evaluations will be carried out at 12 and 24 months.