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Treatment of FBSS Low Back Pain with a Novel Percutaneous DRG Wireless Stimulator: Pilot and Feasibility Study.
Pain Med. 2016 10; 17(10):1911-1916.PM

Abstract

OBJECTIVES

Test a miniaturized neurostimulator transforaminally placed at the dorsal root ganglion (DRG) and evaluate the device's safety and efficacy in treating failed back surgery syndrome (FBSS) low back pain.

DESIGN

Pilot, two-phase study.

SUBJECTS

Eleven subjects with chronic intractable neuropathic trunk and/or lower limbs pain were included.

METHODS

The system consisted of an implantable, miniaturized stimulator, provided by Stimwave Technologies (Freedom-4) and an external transmitter. Only one stimulator per subject was implanted unilaterally and transforaminally at L1 to L5 levels. During Phase 1 of the study, the stimulators were not anchored. In Phase 2, the stimulators were anchored. Subjects were treated during 45 days after which the stimulator was removed. Pain reduction, implant duration, and stimulator migration were registered.

RESULTS

Overall pain reduction was 59.9%, with only one device placed at one location, covering only a portion of the painful areas in the majority of the subjects. In Phase 1, the non-anchored stimulators migrated a mean of 8.80 mm and in Phase 2 a mean of 1.83 mm. Stimulator migration did not correlate with changes in pain relief. Mean time-to-implant duration was 10 minutes and no adverse events were reported during implant, follow-up period, or after explant.

CONCLUSIONS

The pain reduction results indicate that the Freedom-4 spinal cord stimulation (SCS) Wireless System is a viable treatment of low back pain through stimulation of the DRG, and better overall pain reduction may be achieved by implanting multiple devices. With short percutaneous implant times and excellent safety profile, this new system may offer health cost savings.

Authors+Show Affiliations

*Dallas Neurosurgical & Spine Associates, Texas Health Presbyterian Hospital, Dallas, Texas.Desert Institute for Spine Care, Phoenix, Arizona.Star Medica Hospital, Juárez, Chihuahua, Mexico.Stimwave Technologies, Inc., Fort Lauderdale, Florida, USA laura@stimwave.com.Stimwave Technologies, Inc., Fort Lauderdale, Florida, USA.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27125284

Citation

Weiner, Richard L., et al. "Treatment of FBSS Low Back Pain With a Novel Percutaneous DRG Wireless Stimulator: Pilot and Feasibility Study." Pain Medicine (Malden, Mass.), vol. 17, no. 10, 2016, pp. 1911-1916.
Weiner RL, Yeung A, Montes Garcia C, et al. Treatment of FBSS Low Back Pain with a Novel Percutaneous DRG Wireless Stimulator: Pilot and Feasibility Study. Pain Med. 2016;17(10):1911-1916.
Weiner, R. L., Yeung, A., Montes Garcia, C., Tyler Perryman, L., & Speck, B. (2016). Treatment of FBSS Low Back Pain with a Novel Percutaneous DRG Wireless Stimulator: Pilot and Feasibility Study. Pain Medicine (Malden, Mass.), 17(10), 1911-1916.
Weiner RL, et al. Treatment of FBSS Low Back Pain With a Novel Percutaneous DRG Wireless Stimulator: Pilot and Feasibility Study. Pain Med. 2016;17(10):1911-1916. PubMed PMID: 27125284.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment of FBSS Low Back Pain with a Novel Percutaneous DRG Wireless Stimulator: Pilot and Feasibility Study. AU - Weiner,Richard L, AU - Yeung,Anthony, AU - Montes Garcia,Carlos, AU - Tyler Perryman,Laura, AU - Speck,Benjamin, Y1 - 2016/04/28/ PY - 2016/4/30/pubmed PY - 2017/9/26/medline PY - 2016/4/30/entrez KW - Cost Effectiveness KW - DRG Stimulation KW - Low Back Pain KW - Miniaturized Neurostimulator KW - Transforaminal KW - Wireless SCS SP - 1911 EP - 1916 JF - Pain medicine (Malden, Mass.) JO - Pain Med VL - 17 IS - 10 N2 - OBJECTIVES: Test a miniaturized neurostimulator transforaminally placed at the dorsal root ganglion (DRG) and evaluate the device's safety and efficacy in treating failed back surgery syndrome (FBSS) low back pain. DESIGN: Pilot, two-phase study. SUBJECTS: Eleven subjects with chronic intractable neuropathic trunk and/or lower limbs pain were included. METHODS: The system consisted of an implantable, miniaturized stimulator, provided by Stimwave Technologies (Freedom-4) and an external transmitter. Only one stimulator per subject was implanted unilaterally and transforaminally at L1 to L5 levels. During Phase 1 of the study, the stimulators were not anchored. In Phase 2, the stimulators were anchored. Subjects were treated during 45 days after which the stimulator was removed. Pain reduction, implant duration, and stimulator migration were registered. RESULTS: Overall pain reduction was 59.9%, with only one device placed at one location, covering only a portion of the painful areas in the majority of the subjects. In Phase 1, the non-anchored stimulators migrated a mean of 8.80 mm and in Phase 2 a mean of 1.83 mm. Stimulator migration did not correlate with changes in pain relief. Mean time-to-implant duration was 10 minutes and no adverse events were reported during implant, follow-up period, or after explant. CONCLUSIONS: The pain reduction results indicate that the Freedom-4 spinal cord stimulation (SCS) Wireless System is a viable treatment of low back pain through stimulation of the DRG, and better overall pain reduction may be achieved by implanting multiple devices. With short percutaneous implant times and excellent safety profile, this new system may offer health cost savings. SN - 1526-4637 UR - https://www.unboundmedicine.com/medline/citation/27125284/Treatment_of_FBSS_Low_Back_Pain_with_a_Novel_Percutaneous_DRG_Wireless_Stimulator:_Pilot_and_Feasibility_Study_ L2 - https://academic.oup.com/painmedicine/article-lookup/doi/10.1093/pm/pnw075 DB - PRIME DP - Unbound Medicine ER -