Lind 2015.
Study characteristics | ||
Methods | Country: Sweden Design: cross‐over RCT Comparison(s) of interest to this review: SCS (conventional) vs sham |
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Participants | Diagnosis/ diagnostic criteria: Irritable bowel syndrome Duration of pain, years mean (range): 7.6 (3‐14) Age, years range: 25‐56 Sex: 7 F 3 M N randomised = 10 |
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Interventions | Type of SNMD: Conventional SCS Device details: Itrel‐3 Medtronic Electrode type/ number: Quadripolar SCS‐lead, 1, T11‐12 level Stimulation parameters: 50 Hz with other parameters (electrode pole combinations, pulse amplitude 1.3–3.3 V, and pulse width 200–500 s) set to produce adequate paresthesia covering the usual region of pain with comfortable intensity. Comparator: stimulator switched off. Details of pre‐implantation trial period: no pre‐implantation trial period reported. Duration of stimulation: 6 weeks for first phase of cross‐over |
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Outcomes | Primary: pain intensity, average pain level for the day, 0‐10 VAS, anchors not reported Adverse events (methods not reported) Secondary: HR‐QoL ‐ 0‐10 VAS, anchors not reported Time points: End of 6‐week first phase. |
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Notes | Study funding: quote;"The study was supported by Medtronic providing the entire SCS systems. The study had economic support from Karolinska Institutet, Uppsala University, The Swedish Society of Medicine, and the Bengt Ihre fund...Medtronic Inc., Minneapolis, MN supported the trial with all the implant materials but had no impact on the study design, analysis or interpretation of the results." Author conflicts of interest: "The authors G.L., J.W., B.L. or P.M.H. have no competing financial or other interests to report." |