The aim of the study is to evaluate the effectiveness of using ECAP (electrically evoked compound action potential)-controlled CL (closed-loop) SCS (spinal cord stimulation) to treat chronic pelvic pain by stimulating an area in the spine called the conus medullaris (the lowermost tapering extremity of the spinal cord).
Subject is 18 years of age or older at the time of enrollment.
Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm pain) at baseline.
Subject has been diagnosed with chronic intractable pain of the trunk and/or limbs specifically related to pelvic/genital/perineal/anorectal pain, which has been refractory to conservative therapy for a minimum of 6 months.
Subject has pain resulting from a known injury (surgery or trauma).
Subject is pregnant or nursing.
Subject is involved in a malignancy or injury claim under current litigation or has pending/approved worker's compensation claim.
Subject's mechanism of pain is unknown.
Suspected cause and onset of pain are more than 30 days apart.
Patients aged 18 or older with chronic, intractable pelvic pain
Cohort
Prospective
Saluda Evoke Smart SCS System
DeviceSurgical implantation of the Saluda Evoke Smart SCS System targeting the conus medullaris for stimulation
Efficacy: Proportion of patients achieving at least 50% and 80% relief from pelvic pain and pelvic pain-related negative impact to quality of life compared to baseline
Pelvic Pain Reduction will be evaluated using the Visual Analog Scale (VAS) by comparing baseline VAS Scores to 3-, 6-, and 12- month post ECAP CL-SCS Implant VAS Scores.
Impact of pain on activities of daily living: Proportion of patients achieving at least 50% and 80% reduction in impact of pain on activities of daily living compared to baseline.
Evaluate changes in impact of pain on activities of daily living from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using Pain Disability Index (PDI).
Changes in Pain quality: Proportion of patients achieving at least 50% and 80% relief in regard to pain quality compared to baseline
Evaluate changes in Pain quality from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using the Short Form-McGill Pain Questionnaire-2 (SF-MPQ2).
Changes in Health-Related Quality of life: Proportion of patients achieving at least 50% and 80% improvement in health-related quality of life compared to baseline.
Evaluate changes in health-related quality of life from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using EQ-5D-5L (The EuroQol 5 Dimension 5 Level self-report survey).
Changes in sleep quality: Proportion of patients achieving at least 50% and 80% improvement in sleep quality compared to baseline.
Evaluate changes in sleep quality and disturbances from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using Pittsburgh Sleep Quality Index (PSQI) questionnaire.
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Ainsworth Institute of Pain Management
Lead sponsor
Saluda Medical Pty Ltd
Collaborator
