ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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 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

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.





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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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