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

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ClinicalTrials.gov Identifier: NCT01665040
Recruitment Status : Completed
First Posted : August 15, 2012
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Neurostimulation device implantation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs
Actual Study Start Date : August 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation [ Time Frame: 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.

  2. Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01665040     History of Changes
Other Study ID Numbers: A5004
First Posted: August 15, 2012    Key Record Dates
Results First Posted: January 3, 2019
Last Update Posted: January 3, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Boston Scientific Corporation:
neurostimulation
spinal cord stimulation
peripheral nerve stimulation

Additional relevant MeSH terms:
Chronic Pain
Pain, Intractable
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms