دورية أكاديمية
Combination therapy with simultaneous delivery of spinal cord stimulation modalities: COMBO randomized controlled trial.
| العنوان: | Combination therapy with simultaneous delivery of spinal cord stimulation modalities: COMBO randomized controlled trial. |
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| المؤلفون: | Wallace MS; University of California, San Diego, San Diego, CA, 92093, USA., North JM; Carolinas Pain Institute & the Center for Clinical Research, Winston-Salem, NC, 27103, USA., Phillips GM; Pacific Sports & Spine, Eugene, OR, 97401, USA., Calodney AK; Precision Spine Care, Tyler, TX, 75701, USA., Scowcroft JA; Pain Management Associates, Lee's Summit, MO, 64086, USA., Popat-Lewis BU; Michigan Pain Consultants, Big Rapids, MI, 49307, USA., Lee JM; Evergreen Health Medical Group, Kirkland, WA, 98034, USA., Washabaugh EP 3rd; Michigan Pain Specialists, Ypsilanti, MI, 48198, USA., Paez J; South Lake Pain Institute, Clermont, FL, 34711, USA., Bolash RB; Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA., Noles J; Spine & Pain Specialists, Shreveport, LA, 71105, USA., Atallah J; The Toledo Clinic, Toledo, OH, 43606, USA., Shah B; Carolinas Pain Center, Huntersville, NC, 28078, USA., Ahadian FM; University of California, San Diego, San Diego, CA, 92093, USA., Trainor DM; The Denver Spine & Pain Institute, Denver, CO, 80033, USA., Chen L; Boston Scientific Neuromodulation, Valencia, CA, 91355, USA., Jain R; Boston Scientific Neuromodulation, Valencia, CA, 91355, USA. |
| المصدر: | Pain management [Pain Manag] 2023 Mar; Vol. 13 (3), pp. 171-184. Date of Electronic Publication: 2023 Mar 03. |
| نوع المنشور: | Randomized Controlled Trial; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Future Medicine Country of Publication: England NLM ID: 101555934 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1758-1877 (Electronic) Linking ISSN: 17581869 NLM ISO Abbreviation: Pain Manag Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: London : Future Medicine |
| مواضيع طبية MeSH: | Spinal Cord Stimulation* , Chronic Pain*/therapy, Humans ; Paresthesia ; Combined Modality Therapy ; Treatment Outcome ; Spinal Cord |
| مستخلص: | Aim: The Combining Mechanisms for Better Outcomes randomized controlled trial assessed the effectiveness of various spinal cord stimulation (SCS) modalities for chronic pain. Specifically, combination therapy (simultaneous use of customized sub-perception field and paresthesia-based SCS) versus monotherapy (paresthesia-based SCS) was evaluated. Methods: Participants were prospectively enrolled (key inclusion criterion: chronic pain for ≥6 months). Primary end point was the proportion with ≥50% pain reduction without increased opioids at the 3 month follow-up. Patients were followed for 2 years. Results: The primary end point was met (n = 89; p < 0.0001) in 88% of patients in the combination-therapy arm (n = 36/41) and 71% in the monotherapy arm (n = 34/48). Responder rates at 1 and 2 years (with available SCS modalities) were 84% and 85%, respectively. Sustained functional outcomes improvement was observed out to 2 years. Conclusion: SCS-based combination therapy can improve outcomes in patients with chronic pain. Clinical Trial Registration: NCT03689920 (ClinicalTrials.gov), Combining Mechanisms for Better Outcomes (COMBO). |
| معلومات مُعتمدة: | Boston Scientific Corporation |
| فهرسة مساهمة: | Keywords: SCS; chronic pain; combination therapy; randomized controlled trial; spinal cord stimulation Local Abstract: [plain-language-summary] Spinal cord stimulation (SCS) is a device-based therapy for chronic pain that delivers electrical impulses to the spinal cord, disrupting pain signals to the brain. Pain relief can be achieved using different SCS techniques that use or do not use paresthesia (stimulation that produces a tingling sensation). These approaches affect patients in different ways, suggesting that different biological processes are involved in enabling pain relief. Research also suggests that better long-term results occur when patients can choose the therapy that is best for their own needs. This clinical study compared pain relief and other functional activities in those receiving combination therapy (simultaneous use of SCS that does and does not produce tingling sensation) against those receiving monotherapy (only SCS therapy producing tingling sensation) for 3 months. In the study, 88% of those receiving combination therapy and 71% with monotherapy alone reported a 50% (or greater) decrease in overall pain (the ‘responder rate’) without an increased dose of opioid drugs at 3 months after the start of therapy. This responder rate was found to be 84% at 1 year and 85% at 2 years (with all SCS therapy options available). Analysis of functional activities or disability showed that patients improved from ‘severely disabled’ at study start to ‘moderately disabled’ after 2 years, indicating that effective long-term (2 year) improvement can be achieved using SCS-based combination therapy for chronic pain. |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03689920 |
| تواريخ الأحداث: | Date Created: 20230303 Date Completed: 20230503 Latest Revision: 20230503 |
| رمز التحديث: | 20231215 |
| DOI: | 10.2217/pmt-2022-0101 |
| PMID: | 36866658 |
| قاعدة البيانات: | MEDLINE |
PDF full text from Publisher | تدمد: | 1758-1877 |
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| DOI: | 10.2217/pmt-2022-0101 |