2.7. Outcome assessment and follow-up
Oswestry disability, pain, NRS, diabetes
ADVERSE EVENTS, HYPERTENSION, COMPLICATIONS, DIABETES
As part of the baseline data, we will include information such as age, sex, height, weight, body mass index, coexisting medical conditions (e.g., diabetes and hypertension), diagnosis, total duration of pain, target level of the affected nerve root, and the number of prior epidural injections. For intra-operative information, we will collect the stimulating voltages used during electrical stimulation positioning with 50 and 2 Hz of electrical stimulation, procedure duration, output voltage, impedance, and electric field intensity ([output voltage]2/resistance).Outcome measures will include: radicular pain intensity; physical functioning; global improvement and satisfaction with treatment; and adverse events. An 11-point NRS (0 = no pain, 10 = unbearable pain) will be used to assess radicular pain intensity; the Korean version 10-item Oswestry disability index (ODI) questionnaire (range: 0–100; 0 = no disablility) will be used to assess physical function; global perceived effect according to the 7-point Likert scale will be used to assess patient satisfaction and improvement; and adverse events during treatment and follow-up will be individually recorded.The primary outcome will be NRS and ODI at 1, 2, and 3 months after the procedure. The reduction in pain intensity and decrease in ODI compared with baseline. Complications that occur during the procedure will be reported, if present, and adverse events will be further evaluated during the monthly follow-up visits.