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

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Device: Neurostimulation device implantation

• Registration Number: NCT01665040
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-09
• Study First Submitted QC: 2012-08-13
• Study First Posted: 2012-08-15
• Primary Completion: 2014-05
• Study Completion: 2014-12
• Results First Submitted: 2018-08-01
• Results First Submitted QC: 2018-12-13
• Results First Posted: 2019-01-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurostimulation for chronic pain	Neurostimulation device implantation	Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs.

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation	365 days post permanent 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.
Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation	90-days post permanent 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.

Trial Locations

Locations (7)

Metro Spinal Clinic; 🇦🇺 Caulfield, Australia

Hunter Clinical Research; 🇦🇺 Melbourne, Australia

Clinica Universitaria de Navarra; 🇪🇸 Madrid, Spain

AZ Delta; 🇧🇪 Roeselare, Belgium

Hospital La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Quiron Madrid; 🇪🇸 Madrid, Spain

H. Clinico Universitario; 🇪🇸 Valencia, Spain