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Evaluation of the Effectiveness of Percutaneous Octapolar Leads in Pain Treatment with Spinal Cord Stimulation of Patients with Failed Back Surgery Syndrome During a 1-Year Follow-Up: A Prospective Multicenter International Study.
Pain Pract. 2017 04; 17(4):428-437.PP

Abstract

OBJECTIVE

To evaluate the effectiveness and safety of percutaneous octapolar (8-contact) leads in spinal cord stimulation (SCS) treatment of failed back surgery syndrome (FBSS) patients who have not reached their therapy goals with other treatment interventions.

METHODS

Our prospective, multicenter, open-label, nonrandomized study included 93 patients ≥ 18 years of age suffering from chronic (≥ 6 months), intractable pain predominantly in the legs. Patients implanted with octapolar lead(s) and a neurostimulator after a successful test trial were followed for 12 months. Patients provided self-reported data on change in visual analog scale (VAS) score for leg pain (primary outcome) and low back pain, quality of life (EuroQol 5 dimensions [EQ-5D] index), sleep, medication use, and paresthesia coverage (secondary outcomes). Adverse events and preferred stimulation settings were documented.

RESULTS

Eighty-one (87%) patients had a successful SCS trial. Patients reported significantly improved leg pain relief; average VAS score was 72 ± 17 prior to SCS treatment and 32 ± 24 at 12 months (P < 0.001). Significant decrease in back pain (P < 0.001), improvement in quality of life (P < 0.001), and improvement in sleep (P < 0.05) was observed. Sixty-three percent and 40% of patients were responders (≥ 50% pain reduction) on leg and back pain, respectively, after 12 months. A decrease in medication use was seen for antidepressants and anticonvulsants. Eighty-eight percent of the patients managed with 1 or 2 programs for optimal effect and paresthesia coverage. Twenty-five SCS-related adverse events were registered in 22 patients (24%). Surgical revision due to lead displacement or dysfunction was needed in 6 (6%) of the patients.

CONCLUSIONS

Use of percutaneous octapolar SCS leads gives significant long-term pain relief and improvement in quality of life and sleep in FBSS patients. The outcomes are better than reported on 4-contact leads and indicate that the progress in SCS technology that has taken place during the past decade correlates with therapy improvements.

Authors+Show Affiliations

Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.Department of Neurosurgery, Stavanger University Hospital, Stavanger, Norway.Neuromodulation External Research & Innovation, Medtronic Europe, Eindhoven, the Netherlands.

Pub Type(s)

Journal Article
Multicenter Study
Observational Study

Language

eng

PubMed ID

27435009

Citation

Gatzinsky, Kliment, et al. "Evaluation of the Effectiveness of Percutaneous Octapolar Leads in Pain Treatment With Spinal Cord Stimulation of Patients With Failed Back Surgery Syndrome During a 1-Year Follow-Up: a Prospective Multicenter International Study." Pain Practice : the Official Journal of World Institute of Pain, vol. 17, no. 4, 2017, pp. 428-437.
Gatzinsky K, Baardsen R, Buschman HP. Evaluation of the Effectiveness of Percutaneous Octapolar Leads in Pain Treatment with Spinal Cord Stimulation of Patients with Failed Back Surgery Syndrome During a 1-Year Follow-Up: A Prospective Multicenter International Study. Pain Pract. 2017;17(4):428-437.
Gatzinsky, K., Baardsen, R., & Buschman, H. P. (2017). Evaluation of the Effectiveness of Percutaneous Octapolar Leads in Pain Treatment with Spinal Cord Stimulation of Patients with Failed Back Surgery Syndrome During a 1-Year Follow-Up: A Prospective Multicenter International Study. Pain Practice : the Official Journal of World Institute of Pain, 17(4), 428-437. https://doi.org/10.1111/papr.12478
Gatzinsky K, Baardsen R, Buschman HP. Evaluation of the Effectiveness of Percutaneous Octapolar Leads in Pain Treatment With Spinal Cord Stimulation of Patients With Failed Back Surgery Syndrome During a 1-Year Follow-Up: a Prospective Multicenter International Study. Pain Pract. 2017;17(4):428-437. PubMed PMID: 27435009.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of the Effectiveness of Percutaneous Octapolar Leads in Pain Treatment with Spinal Cord Stimulation of Patients with Failed Back Surgery Syndrome During a 1-Year Follow-Up: A Prospective Multicenter International Study. AU - Gatzinsky,Kliment, AU - Baardsen,Roald, AU - Buschman,Hendrik P, Y1 - 2016/07/20/ PY - 2016/02/06/received PY - 2016/04/27/revised PY - 2016/05/10/accepted PY - 2016/7/21/pubmed PY - 2017/6/29/medline PY - 2016/7/21/entrez KW - chronic pain KW - failed back surgery syndrome KW - neuromodulation technology KW - pain relief KW - percutaneous leads KW - spinal cord stimulation SP - 428 EP - 437 JF - Pain practice : the official journal of World Institute of Pain JO - Pain Pract VL - 17 IS - 4 N2 - OBJECTIVE: To evaluate the effectiveness and safety of percutaneous octapolar (8-contact) leads in spinal cord stimulation (SCS) treatment of failed back surgery syndrome (FBSS) patients who have not reached their therapy goals with other treatment interventions. METHODS: Our prospective, multicenter, open-label, nonrandomized study included 93 patients ≥ 18 years of age suffering from chronic (≥ 6 months), intractable pain predominantly in the legs. Patients implanted with octapolar lead(s) and a neurostimulator after a successful test trial were followed for 12 months. Patients provided self-reported data on change in visual analog scale (VAS) score for leg pain (primary outcome) and low back pain, quality of life (EuroQol 5 dimensions [EQ-5D] index), sleep, medication use, and paresthesia coverage (secondary outcomes). Adverse events and preferred stimulation settings were documented. RESULTS: Eighty-one (87%) patients had a successful SCS trial. Patients reported significantly improved leg pain relief; average VAS score was 72 ± 17 prior to SCS treatment and 32 ± 24 at 12 months (P < 0.001). Significant decrease in back pain (P < 0.001), improvement in quality of life (P < 0.001), and improvement in sleep (P < 0.05) was observed. Sixty-three percent and 40% of patients were responders (≥ 50% pain reduction) on leg and back pain, respectively, after 12 months. A decrease in medication use was seen for antidepressants and anticonvulsants. Eighty-eight percent of the patients managed with 1 or 2 programs for optimal effect and paresthesia coverage. Twenty-five SCS-related adverse events were registered in 22 patients (24%). Surgical revision due to lead displacement or dysfunction was needed in 6 (6%) of the patients. CONCLUSIONS: Use of percutaneous octapolar SCS leads gives significant long-term pain relief and improvement in quality of life and sleep in FBSS patients. The outcomes are better than reported on 4-contact leads and indicate that the progress in SCS technology that has taken place during the past decade correlates with therapy improvements. SN - 1533-2500 UR - https://www.unboundmedicine.com/medline/citation/27435009/Evaluation_of_the_Effectiveness_of_Percutaneous_Octapolar_Leads_in_Pain_Treatment_with_Spinal_Cord_Stimulation_of_Patients_with_Failed_Back_Surgery_Syndrome_During_a_1_Year_Follow_Up:_A_Prospective_Multicenter_International_Study_ L2 - https://doi.org/10.1111/papr.12478 DB - PRIME DP - Unbound Medicine ER -