Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain

Study Overview
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Brief Summary
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The primary objective of this study is to investigate patient satisfaction with treatment using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.

Official Title
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Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Neurostimulation device implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic intractable pain of the trunk and/or limbs Documented history of trunk and/or limb pain of at least 180 days Overall pain intensity of at least 5 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall Pass study site's routine psychological/psychiatric evaluation within 180 days before signing the informed consent Subject is willing and able to comply with all protocol-required follow-up evaluations 18 years of age or older when written informed consent is obtained Subject signs informed consent Exclusion Criteria: Unable to operate the Precision Spectra™ System either by self or with a caregiver Primary source of pain is cancer-related, pelvic, visceral, anginal or migraine Overall pain intensity of always 10 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall Is a high surgical risk Currently on any anticoagulant medications that cannot be discontinued during perioperative period Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s) and/or the Precision Spectra IPG Subject is participating (or intends to participate) in another investigational drug or device clinical trial that may influence the data that will be collected for this study Subjects already implanted with an active implantable device(s) to treat their pain (IPGs, implantable drug pumps, etc) or pacemaker or Implantable Cardiac Defibrillator Patient is a woman who is pregnant (a urine pregnancy test must be performed within 7 days prior to the stimulation trial procedure in women of child-bearing potential) or nursing or intends to become pregnant during the course of the trial. Failed to achieve satisfactory relief during the stimulation trial phase

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurostimulation for chronic pain<br>Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs. | Device: Neurostimulation device implantation<br>* Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial. Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation | Proportion of subjects satisfied with treatment at 90 days post-IPG implantation, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire. | 90-days post permanent implantation | 
| Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation | Proportion of subjects in a sub-group utilizing more than 2 IPG ports at 365 Days post-IPG implantation satisfied with treatment, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire. | 365 days post permanent implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurostimulation, spinal cord stimulation, peripheral nerve stimulation