Prospective, Multicenter Feasibility Study to Evaluate Differential Target Multiplexed Spinal Cord Stimulation Programming in Subjects With Chronic Intractable Back Pain With or Without Leg Pain.
Objective: This prospective, open‐label, multicenter study evaluated the feasibility of spinal cord stimulation (SCS) therapy programming for chronic low back pain that uses multiple electrical pulsed signals (Differential Target Multiplexed). Methods: Twenty‐five SCS candidates with low back pain e...
| Publicado en: | Pain Practice Vol. 20; no. 7; pp. 761 - 769 |
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| Autores principales: | , , , , , , , , , , , |
| Formato: | clinical trial pictorial research tables/charts Journal Article |
| Publicado: |
Wiley-Blackwell
Sep2020
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=145719083&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 145719083 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 15307085 HYN jtl: Pain Practice issn: 15307085 maglogo: Y pubinfo: dt: Sep2020 vid: 20 iid: 7 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 145719083 145719083 145719083 10.1111/papr.12908 145719083 ppf: 761 ppct: 8 formats: fmt: @attributes: type: P tig: atl: Prospective, Multicenter Feasibility Study to Evaluate Differential Target Multiplexed Spinal Cord Stimulation Programming in Subjects With Chronic Intractable Back Pain With or Without Leg Pain. aug: au: Fishman, Michael A. Calodney, Aaron Kim, Philip Slezak, Jan Benyamin, Ramsin Rehman, Atiq Soto, Eliezer Yang, Thomas Hacobian, Asteghik Griffith, Lee Yu, Cong Vallejo, Ricardo affil: Center for Interventional Pain and Spine, Exton Pennsylvania, U.S.A. sug: subj: Spinal Cord Stimulation Methods Pain Management Methods Chronic Pain Therapy Low Back Pain Therapy Leg Pathology Pain Therapy Treatment Outcomes Human Prospective Studies Multicenter Studies Pilot Studies United States Descriptive Statistics Scales Pain Measurement Middle Age Aged Clinical Trials Electrodes, Implanted Middle Aged: 45-64 years Aged: 65+ years ab: Objective: This prospective, open‐label, multicenter study evaluated the feasibility of spinal cord stimulation (SCS) therapy programming for chronic low back pain that uses multiple electrical pulsed signals (Differential Target Multiplexed). Methods: Twenty‐five SCS candidates with low back pain equal to or greater than lower limb pain were enrolled at 7 sites in the United States. The subjects evaluated standard and Differential Target Multiplexed programs, each for 4 ± 1 days. A commercially available SCS trial system was used for standard SCS therapy programming. During the trialing of the multiplexed programs, implanted temporary leads were connected to an investigational external trial stimulator system. Results: Twenty subjects concluded the study. The mean baseline numeric pain rating scale (NPRS) score for low back pain was 7.4, with a mean age of 62.4 years and mean pain duration of 18.0 years. Significant relief in back pain was observed for both treatments, with significantly better response with multiplexed programming. At the end of the trial period, subjects reported a reduction in their mean NPRS score from baseline to 4.2 after standard programming and to 2.4 after Differential Target Multiplexed programming. The difference between standard and multiplexed programming was significant. The responder rate for low back pain relief was 50% for standard programming and 80% for Differential Target Multiplexed programming. Eighty‐five percent of subjects who evaluated both programming approaches preferred Differential Target Multiplexed SCS. Conclusion: In this difficult‐to‐treat patient population, subjects reported significant reduction in chronic back pain when using multiplexed programming. A randomized clinical trial is needed to confirm the results from this feasibility study. pubtype: Academic Journal doctype: clinical trial pictorial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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