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

Not Applicable

Completed

• Conditions: Chronic Pain

• 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

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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

AZ Delta; 🇧🇪 Roeselare, Belgium

Clinica Universitaria de Navarra; 🇪🇸 Madrid, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Quiron Madrid; 🇪🇸 Madrid, Spain

H. Clinico Universitario; 🇪🇸 Valencia, Spain