RecruitingACTRN12614000665639

High-Frequency Spinal Cord Stimulation at 10kHz (HF10 SCS) for the Treatment of Post-Surgery Back Pain Patients

A prospective, single-center, observational data collection study of high-frequency spinal cord stimulation at 10kHz (HF10 SCS) for the Treatment of Post-Surgery Back Pain Patients


Sponsor

Dr. Paul Verrills

Enrollment

100 participants

Start Date

Nov 5, 2013

Study Type

Observational

Conditions

Summary

Patients with persistent back pain and suspected mechanical instability are referred to spine surgeons for spine stability assessment and, if need be, stabilization surgery. A significant proportion of these patients fail however to derive adequate benefits from the surgery and these chronic pain 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. High-Frequency Spinal Cord Stimulation at 10 kHz (HF10 SCS) has established itself as a key treatment in treating patients with chronic back pain: data from European 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. HF10 SCS has been used in Australia to treat chronic pain ever since its TGA approval, especially back and leg pain patients. The purpose of this non-interventional data collection study is to collect data on the improvement in pain relief and quality of life associated with HF10 SCS, as used in the clinic routine practice in patients with chronic back pain following back surgery.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Some people continue to have serious back pain after having spine surgery, a condition sometimes called failed back surgery syndrome. High-frequency spinal cord stimulation at 10 kHz (HF10 SCS) is a technique where a small device delivers electrical signals to the spinal cord to block pain signals. This study is collecting real-world data on how well this treatment reduces pain and improves quality of life and sleep in patients who have had spine surgery and still experience chronic back pain. You may be eligible if: - You are 18 years of age or older - You have had spine surgery that resulted in ongoing back pain - You have been diagnosed with back pain (or back and leg pain) for at least 6 months - Your back pain is rated at least 5 out of 10 on a pain scale - You are a candidate for HF10 spinal cord stimulation according to your treating centre's practice You may NOT be eligible if: - You are currently enrolled in another clinical study that could affect the results Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. 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 back pain +/- leg pain following spinal surgery via spinal cord stimulation.

Twelve month observation of patients implanted with the Senza System for management of chronic back pain +/- leg pain following spinal surgery via spinal cord stimulation.


Locations(1)

VIC, Australia

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ACTRN12614000665639