Subcutaneous Stimulation as ADD-ON Therapy to Spinal Cord Stimulation Is Effective in Treating Low Back Pain in Patients With Failed Back Surgery Syndrome: A Multicenter Randomized Controlled Trial

A Retrospective Analysis of 25 Cases With Peripheral Nerve Field Stimulation for Chronic Low Back Pain and the Predictive Value of Transcutaneous Electrical Nerve Stimulation for Patient Selection

“…Our results show that PNFS had a clinically and statistically significant effect on relieving chronic low back pain and improving quality of life. These results are in accordance with the current literature (15,18,19,21,29,42,45,46). Besides these significant results, our results show an increase of values for positive mood, and a reduction in values for desperation, sorrow, fatigue, and anger in the whole follow-up period after PNFS implantation on ASTS, a German modified version of the POMS.…”

“…In PNFS, the stimulation through subcutaneous insertion is deeper and has a higher current density (26). PNFS itself is an effective therapy that, to date, remains rarely used even if PNFS as a neuromodulative treatment showed good results in treatment of chronic low back pain in recent years (15,(17)(18)(19)44). In the therapy of low back pain PNFS could also be seen even as a stand-alone therapy (21).…”

“…Peripheral nerve field stimulation (PNFS) may be proposed to patients with chronic low back pain refractory to conventional medical treatment to improve pain relief, functional capacity, and quality of life. If first choice conventional medical management options fail, PNFS has become an important option in the treatment of chronic low back pain (11)(12)(13)(14)(15)(16). Previous studies presented favorable clinical outcomes with a pain reduction in 70-85% in patients with chronic low back pain after PNFS treatment (17)(18)(19)(20).…”

Long-Term Effect of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation to Treat Low Back Pain in Failed Back Surgery Syndrome Patients: A 12-Month Follow-Up of a Randomized Controlled Study

“…This study concerns the 12-month follow-up of the multicenter randomized controlled trial on the effectiveness of PNFS as an ADD-ON therapy to SCS for treating low back pain in FBSS patients (Clinical Trials.gov ID: NCT01776749). Details of the inclusion and exclusion criteria implant procedure and assessments have been published previously (17). The study-design met the specific demands of the ethical committee.…”

“…A statistical significant reduction of back and leg pain was found at 12 months in a feasibility study conducted by our group (16), in a group of FBSS patients treated with PNFS in addition to SCS. To evaluate whether PNFS in combination to SCS is effective in treating CLBP patients where SCS was only effective for pain in the legs, we previously performed a randomized controlled study in 52 patients and allocated them to the PNFS-SCS group (subcutaneous leads activated, n 5 28) or to the SCS group (n 5 24) (17). At three months, the percentage of patients with 50% reduction of back pain was significantly higher in the PNFS-SCS group (42.9%) compared to the SCS group (4.2%).…”