RecruitingACTRN12614000989640

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


Sponsor

Dr. Bruce Mitchell

Enrollment

30 participants

Start Date

Aug 14, 2014

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a newer type of spinal cord stimulation (SCS) using high-frequency electrical pulses at 10 kHz — delivered through a device called the Senza system — can provide meaningful pain relief and improve quality of life for people with chronic, hard-to-treat pelvic pain. You may be eligible if: - You are 18 years or older - You have chronic intractable pelvic pain (including conditions like interstitial cystitis, vulvodynia, endometriosis, pelvic girdle pain, or pudendal neuralgia) - Your worst pelvic pain is at least 5 out of 10 on a pain scale - Your pain medications have been stable for at least 28 days - You have decided to pursue the Senza SCS system for treatment You may NOT be eligible if: - You have cancer or a malignant disease - You have an active psychological or psychiatric condition that affects pain perception - You have a progressive neurological disease (e.g., multiple sclerosis) - You have an active infection or a coagulation (blood clotting) disorder - You are pregnant - You have a pacemaker or other active implanted device - You have had pelvic laparoscopy within the last 6 months - You are involved in active litigation or a workers' compensation claim Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 do

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)

VIC, Australia

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ACTRN12614000989640