This retrospective data collection study aims to evaluate the responses of patients who have been implanted with a neuromodulation system using a combination of spinal cord stimulation (SCS) and peripheral subcutaneous field stimulation (PSFS) leads for chronic intractable pain.Materials and Methods:
Forty patients with chronic, intractable pain implanted with both SCS and PSFS leads were enrolled in a retrospective data collection study. Pre-implant data (demographics, pain levels, pain location, and medication use) and post-implant data (pain levels, medication use, and device programming reports) were compared to measure short- and long-term improvements in pain for a period of approximately six months. Device system use and parameter data were collected.Results:
The majority of patients experienced immediate and short-term pain relief and reduction in oral pain medications as a result of combination SCS/PSFS therapy. The improvements were maintained for some, but not all patients by six months. Patients cycled through multiple programs over follow-up; the use of triangular stimulation was consistent over time, and by six months, patients preferred this program over others. Limitations of the retrospective chart review included missing data and variable follow-up times, and may have made determinations of long-term efficacy difficult.Conclusions:
This study demonstrates that combination SCS and PSFS therapy is potentially a beneficial treatment option for reducing pain levels and oral pain medication compared with baseline in previously resistive chronic pain patients. There is a need for further study of this therapy in a greater number of subjects and in a prospective, controlled setting. In the author's general experience, triangular stimulation is very effective for treating isolated low back pain, because it covers larger topographic areas of the lower back than flow or field stimulation. An investigational device exemption study will be necessary for subcutaneous field stimulation indicated for focal isolated pain to be adequately investigated and utilized by physicians in the future.