Ainsworth Institute of Pain Management
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).
Primary Objective Evaluate the efficacy of ECAP CL-SCS in treating chronic pelvic pain. Secondary Objectives Evaluate changes in impact of pain on activities of daily living, pain quality, quality of life, sleep, anxiety and depression, pain catastrophizing, patient satisfaction, and symptoms related to urinary urgency frequency. Evaluate safety of using ECAP-controlled CL-SCS in treating chronic pelvic pain. Summarize and evaluate device performance and typical programming parameters. Study design This protocol describes an observational, prospective, single-arm, single center study. Eligi…
Inclusion Criteria: 1. Subject is 18 years of age or older at the time of enrollment. 2. Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm pain) at baseline. 3. 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. 4. Subject has pain resulting from a known injury (surgery or trauma). 5. Subject has been clinically diagnosed with chronic pelvic pain (pain that occurs in the region of the p…
Surgical implantation of the Saluda Evoke Smart SCS System targeting the conus medullaris for stimulation
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