The MuscleSCS Technique (4-8Hz BurstDR™ Octrode™): A Randomized Clinical Study of MuscleSCS Stimulation in the Treatment of Chronic Back Pain

Abstract

Background: MuscleSCS is a new technique that combines spinal cord stimulation (SCS) with muscle stimulation to relieve pain. Objectives: In this clinical study, we wanted to use rod electrodes to investigate the MuscleSCS method’s effectiveness in the treatment of chronic lower back pain. One of our hypotheses was that the combined use of MuscleSCS and BurstDR™ would further improve the treatment. Study Design: A prospective, single-center, single-blinded, randomized crossover study. Setting: A university medical center. Methods: Patients with chronic lower back pain had previously (one to 10 years ago) received an SCS system (Octrode™). In this study, they were randomly treated for 2 weeks each with BurstDR™ stimulation alone, MuscleSCS stimulation alone, or a combination of BurstDR™ stimulation and MuscleSCS stimulation. Thereafter, the patients were treated for another 6 weeks with one of the 3 methods (crossover possible). Pain ratings on the visual analog scale (VAS) were recorded and compared. A Pain Disability Index (PDI) questionnaire was used at the baseline and at 3 months. Results: We included 24 patients in this study (11 women, mean age 62.3 yrs.) The values of the second week of the stimulation were the only ones used for the calculations. The first week of the stimulation was used as a wash-out period. The combined application of BurstDR™ and MuscleSCS stimulation was associated with the best results (P = 0.032). PDI scores did not improve during this treatment. No serious adverse events occurred during this study. Seventy-one and a half percent of the subjects experienced an improvement in their pain as a result of the additional MuscleSCS stimulation. Limitations: In this study, only one fixed contact setting (3 & 4) was used to ensure uniform conditions for all patients and the ability to compare the different treatment modes. Conclusion: This study showed that the combined application of SCS (BurstDR™) and additional MuscleSCS stimulation using a rod electrode could significantly improve outcomes for patients suffering from chronic back pain.