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

This study is currently recruiting participants.
Verified November 2013 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01665040
First received: August 9, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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 Intervention
Chronic Pain
Device: Neurostimulation device implantation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Patient satisfaction with treatment [ Time Frame: 90-days post permanent implantation ] [ Designated as safety issue: No ]
    First of 2 co-primary endpoints. It is measured on a 7-point choice of degree of satisfaction scale.

  • Patient satisfaction with treatment [ Time Frame: 365 days post permanent implantation ] [ Designated as safety issue: No ]
    Second of 2 co-primary endpoints. It is measured on a 7-point choice of degree of satisfaction scale.


Secondary Outcome Measures:
  • Patient satisfaction with treatment [ Time Frame: 180-days post permanent implantation ] [ Designated as safety issue: No ]
    Collected on a 7-point choice of degree of satisfaction scale.

  • Global impression of change [ Time Frame: 180-days post permanent implantation ] [ Designated as safety issue: No ]
    Global Impression of Change (GIC) will be assessed by patients, investigators and caregivers. GIC is a comparison to baseline and will be evaluated by rating the global impression of change using a seven-point scale: ("very much improved" to "marked worsening")

  • Overall pain intensity [ Time Frame: Baseline through 365-days post permanent implantation ] [ Designated as safety issue: No ]
    Subjects will rate their overall pain on a 0-10 numerical rating scale.

  • Pain relief responder rate [ Time Frame: Baseline through 365-days post permanent implantation ] [ Designated as safety issue: No ]
    A "responder" is defined as a subject who reports ≥50% reduction in baseline pain.

  • Disability [ Time Frame: Baseline through 365-days post permanent implantation ] [ Designated as safety issue: No ]
    Disability will be assessed using the Oswestry Disability Index v2.1a

  • Global impression of change [ Time Frame: Baseline through 365 days post permanent implantation ] [ Designated as safety issue: No ]
  • Pain-related medication use [ Time Frame: Baseline through 365 days post permanent implantation ] [ Designated as safety issue: No ]
  • Percentage overlap of painful areas with stimulation-induced paresthesia (drawings) [ Time Frame: From 90-days through 365-days post permanent implantation ] [ Designated as safety issue: No ]
    Overlap will be assessed using subject-completed drawings of pain and neurostimulation-induced paresthesia (tingling)

  • Percentage overlap of painful areas with stimulation-induced paresthesias (verbal) [ Time Frame: From 90-days through 365 days post permanent implantation ] [ Designated as safety issue: No ]
    Overlap will be assessed by subject estimation

  • Patient treatment preference [ Time Frame: Baseline through 365-days post permanent implantation ] [ Designated as safety issue: No ]
    Subjects who end up utilizing the full capacity of the implantable system will compare treatment from baseline through 90-days post permanent implantation with treatment from 90-days through 365-days post permanent implantation.


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665040

Contacts
Contact: Nic Van Dyck 31-433568328 Nic.VanDyck@bsci.com
Contact: Diane Bowers 6619494175 Diane.Bowers@bsci.com

Locations
Australia, Victoria
Metro Spinal Clinic Recruiting
Melbourne, Victoria, Australia
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Paul Verrills, M.D. Metro Spinal Clinic
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01665040     History of Changes
Other Study ID Numbers: A5004
Study First Received: August 9, 2012
Last Updated: November 6, 2013
Health Authority: Australia: National Health and Medical Research Council

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

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

ClinicalTrials.gov processed this record on April 17, 2014