High-Frequency Spinal Cord Stimulation at 10kHz (HF10 SCS) for the Treatment of Pelvic Pain Patients
A prospective, single-center, observational data collection study of high-frequency spinal cord stimulation at 10kHz (HF10 SCS) for the Treatment of Pelvic Pain Patients
Dr. Bruce Mitchell
30 participants
Aug 14, 2014
Observational
Conditions
Summary
Chronic pelvic pain (CPP) is one of the most common medical problems among women, though it also affects men with a lower incidence . It is defined as pain in the pelvis that lasts more than six months and affects the patient’s quality of life. There are many potential sources of pelvic pain. Pelvic pain may involve the urinary, reproductive, gastrointestinal, neurological, psychological and musculoskeletal systems. Patients with chronic pelvic pain typically receive multidisciplinary care, including medication (antimicrobials, anti-inflammatories, opioids, muscle relaxants, etc), psychotherapy, physical therapy, and interventional treatments (surgery for distension and ablative procedures). A significant proportion of these patients fail however to derive adequate benefits from these therapies and these CPP patients are often left with few options. Traditional spinal cord stimulation (SCS) is a widely accepted cost-effective therapy for patients with chronic pain, especially in patients with post- surgery back and leg pain. SCS has been used successfully to treat intractable CPP patients. A newer treatment, High-Frequency Spinal Cord Stimulation at 10 kHz (HF10TM SCS) using the Senza system (Nevro Corp, USA) has established itself as a key treatment in treating patients with chronic back pain: data from European and Australian pain centers has shown that HF10 SCS is safe and effective at reducing pain, improving function and sleep, and reducing opioid in patients with predominant back pain. The purpose of this study is to investigate the feasibility of using HF10-SCS to provide pain relief and quality of life improvements to CPP patients.
Eligibility
Plain Language Summary
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Interventions
Twelve month observation of patients implanted with the Senza System for management of chronic, intractable pelvic pain via spinal cord stimulation (SCS). SCS via the Senza System will be at a dose frequency of 10kHz. Duration will be up to 14 days during the trial period, followed by a 12 month oberservation period for those proceeding to a permanent implant. The leads will be placed at sacral root and conus medullaris during the trial period. The permanent leads will be implanted at sacral root OR conus medullaris, based on the outcome of the trial period. The implantable pulse generator (IPG) is implanted as per standard of care/physician discretion (buttock, lateral flank/axillae etc). The duration of the implant procedure may be 20-40mins. The device will be able to be controlled/turned on/off by the participant within the prescribed settings.
Locations(1)
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ACTRN12614000989640