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. 2021 Dec 2;2021(12):CD013756. doi: 10.1002/14651858.CD013756.pub2

Lind 2015.

Study characteristics
Methods Country: Sweden
Design: cross‐over RCT
Comparison(s) of interest to this review: SCS (conventional) vs sham
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
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
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.
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."