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.
Ainsworth Institute of Pain Management
Lead sponsor
Saluda Medical Pty Ltd
Collaborator