RecruitingACTRN12614001274662

An investigation of the therapeutic effect of electrical impulses with short pulse width on pain relief and quality of the spinal cord stimulation in patients with intractable back and/or leg pain.

Sponsor

Dr. Paul Verrills

Enrollment

110 participants

Start Date

Jul 15, 2013

Study Type

Observational

Conditions

Electrical impulses for pain relief in patients with intractable back and/or leg pain

Summary

Prospective, observational study. Subjects who have inadequate pain relief from their currently implanted conventional spinal cord stimulator (Boston Scientific Corp.) will be evaluated for eligibility in this study. The study aims at investigating alternative programming combinations for these spinal cord devices. The programming algorithms are within the currently approved limits for the device. We hope to reduce the stimulation (paraesthesia) to a level in which it is no longer felt by the patient (subthreshold stimulation) but still provides improved pain relief and prolonged optimal therapy for patients with chronic back and leg pain. The potential outcomes of this project have vast applications in chronic pain patients, where patients will often tolerate side effects such as uncomfortable stimulation sensations, so that their pain may be controlled.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing new settings for spinal cord stimulator devices to see if they can provide better pain relief with less discomfort for people with chronic back and leg pain. Spinal cord stimulators are implanted devices that send electrical signals to the spine to block pain. Most patients feel a tingling sensation (paraesthesia) from the device. This study tests whether adjusting the pulse settings can provide pain relief without the tingling sensation — an approach called subthreshold stimulation. You may be eligible if: - You are 18 years or older - You have had low back pain or back and leg pain for at least 6 months - You already have an implanted Boston Scientific spinal cord stimulator - You are willing to complete questionnaires and pain scales as part of the study You may NOT be eligible if: - You are currently enrolled in another clinical study that could interfere with this one 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

This is an observational study of the effects of alternative programming options/combinations, as part of routine standard of care, on chronic intractable back and/or leg pain in patients currently i

This is an observational study of the effects of alternative programming options/combinations, as part of routine standard of care, on chronic intractable back and/or leg pain in patients currently implanted with the Boston Scientific Corporation spinal cord stimulator (BSC SCS). Patients will be followed up 7-10 days following re-programming, and then periodically, as per standard of care, throughout the entire study period (until the study is closed - approximately 24 months). No outcome assessments are conducted post 7-10 days.

Locations(1)

NSW,VIC, Australia

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ACTRN12614001274662