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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Neurostimulation device implantation
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring neurostimulation, spinal cord stimulation, peripheral nerve stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Metro Spinal Clinic
  • Hunter Clinical Research
  • AZ Delta
  • Clinica Universitaria de Navarra
  • Hospital La Paz
  • Hospital Universitario Quiron Madrid
  • H. Clinico Universitario

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurostimulation for chronic pain

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG 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.
Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG 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.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2012
Last Updated
November 17, 2020
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01665040
Brief Title
Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain
Official Title
Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
neurostimulation, spinal cord stimulation, peripheral nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurostimulation for chronic pain
Arm Type
Experimental
Arm Description
Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs.
Intervention Type
Device
Intervention Name(s)
Neurostimulation device implantation
Intervention Description
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 Measure Information:
Title
Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation
Description
Proportion of subjects satisfied with treatment at 90 days post-IPG implantation, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.
Time Frame
90-days post permanent implantation
Title
Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation
Description
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.
Time Frame
365 days post permanent implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshini Jain
Organizational Affiliation
Boston Scientific Neuromodulation Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Metro Spinal Clinic
City
Caulfield
Country
Australia
Facility Name
Hunter Clinical Research
City
Melbourne
Country
Australia
Facility Name
AZ Delta
City
Roeselare
Country
Belgium
Facility Name
Clinica Universitaria de Navarra
City
Madrid
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Quiron Madrid
City
Madrid
Country
Spain
Facility Name
H. Clinico Universitario
City
Valencia
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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