Subcutaneous Stimulation as an Additional Therapy to Spinal Cord Stimulation for the Treatment of Lower Limb Pain and/or Back Pain: A Feasibility Study

Objective: The objective of this study was to demonstrate the efficacy of subcutaneous stimulation (SubQ) as an additional therapy in patients with failed back surgery syndrome (FBSS) with chronic refractory pain, for whom spinal cord stimulation (SCS) was unsuccessful in treating low back pain. Study Design: Case series. Materials and Methods: FBSS patients with chronic limb and/or low back pain whose conventional therapies had failed received a combination of SCS (8‐contact Octad lead) and/or SubQ (4‐contact Quad Plus lead(s)). Initially leads were placed in the epidural space for SCS for a trial stimulation to assess response to suppression of limb and low back pain. Where SCS alone was insufficient in treating lower back pain, leads were placed superficially in the subcutaneous tissue of the lower back, directly in the middle of the pain area. A pulse generator was implanted if patients reported more than 50% pain relief during the trial period. Pain intensity for limb and lower back pain was scored separately, using visual analog scale (VAS). Pain and Quebec Back Pain Disability Scale (QBPDS) after 12‐month treatment were compared with pain and QBPDS at baseline. Results: Eleven FBSS patients, five male and six female (age: 51 ± 8 years; mean ± SD), in whom SCS alone was insufficient in treating lower back pain, were included. In nine cases, SubQ was used in combination with SCS to treat chronic lower back and lower extremity pain. In two cases only SubQ was used to treat lower back pain. SCS significantly reduced limb pain after 12 months (VAS_bl: 62 ± 14 vs. VAS_12m: 20 ± 11; p= 0.001, N= 8). SubQ stimulation significantly reduced low back pain after 12 months (VAS_bl: 62 ± 13.0 vs. VAS_12m: 32 ± 16; p= 0.0002, N= 10). Overall pain medication was reduced by more than 70%. QBPDS improved from 61 ± 15 to 49 ± 12 (p= 0.046, N= 10). Furthermore, we observed that two patients returned to work. Conclusion: SubQ may be an effective additional treatment for chronic low back pain in patients with FBSS for whom SCS alone is insufficient in alleviating their pain symptoms.