Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain
NCT ID: NCT01665040
Last Updated: 2020-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2012-08-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Neurostimulation for chronic pain
Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs.
Neurostimulation device implantation
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.
Interventions
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Neurostimulation device implantation
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Roshini Jain
Role: STUDY_DIRECTOR
Boston Scientific Neuromodulation Corporation
Locations
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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
Countries
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Other Identifiers
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A5004
Identifier Type: -
Identifier Source: org_study_id