OBJECTIVES: The objective of this study was to determine the effects of combining pulsed radiofrequency (PRF) treatment and transforaminal epidural injection (TFEI) to treat patients with chronic refractory lumbar radicular pain caused by lumbar spinal stenosis. STUDY DESIGN: Randomized control trial. SETTINGS: Interventional pain management practice. METHOD: Sixty-two patients were assigned to the study groups (PRF group = 31; control group = 31). Under fluoroscopic guidance, the RF needle was positioned close to the lumbar dorsal root ganglion. The PRF group received 3 cycles of PRF treatment, and sensory stimulation without RF lesioning was applied to the control group. After PRF or sham lesioning, a local anesthetic with steroid was injected. The primary outcome of a successful response was defined as: 1) ≥50% or 4-point pain reduction in the numerical rating scale (NRS) without an increase in the Oswestry disability index (ODI) or medication quantification scale (MQS), or mean score <4 in the global perceived effect (GPE) scale; or 2) ≥30% or 2-point pain reduction in NRS with a simultaneous decrease in ODI, MQS, or ≥6 points in the GPE scale. RESULT: The number of patients with successful treatment results was higher in the PRF group at 2 months (P = 0.032) and 3 months (P = 0.018). No significant differences were observed in terms of the secondary outcome variables between the 2 groups. CONCLUSION: The TFEI provided significant short-term pain relief and PRF can be applied in conjunction with TFEI to achieve higher treatment efficacy compared with TFEI alone. Wiley Periodicals, Inc.
RCT Entities:
OBJECTIVES: The objective of this study was to determine the effects of combining pulsed radiofrequency (PRF) treatment and transforaminal epidural injection (TFEI) to treat patients with chronic refractory lumbar radicular pain caused by lumbar spinal stenosis. STUDY DESIGN: Randomized control trial. SETTINGS: Interventional pain management practice. METHOD: Sixty-two patients were assigned to the study groups (PRF group = 31; control group = 31). Under fluoroscopic guidance, the RF needle was positioned close to the lumbar dorsal root ganglion. The PRF group received 3 cycles of PRF treatment, and sensory stimulation without RF lesioning was applied to the control group. After PRF or sham lesioning, a local anesthetic with steroid was injected. The primary outcome of a successful response was defined as: 1) ≥50% or 4-point pain reduction in the numerical rating scale (NRS) without an increase in the Oswestry disability index (ODI) or medication quantification scale (MQS), or mean score <4 in the global perceived effect (GPE) scale; or 2) ≥30% or 2-point pain reduction in NRS with a simultaneous decrease in ODI, MQS, or ≥6 points in the GPE scale. RESULT: The number of patients with successful treatment results was higher in the PRF group at 2 months (P = 0.032) and 3 months (P = 0.018). No significant differences were observed in terms of the secondary outcome variables between the 2 groups. CONCLUSION: The TFEI provided significant short-term pain relief and PRF can be applied in conjunction with TFEI to achieve higher treatment efficacy compared with TFEI alone. Wiley Periodicals, Inc.