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

This study is currently recruiting participants. (see Contacts and Locations)
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
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, see Learn About Clinical Studies.

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 July 20, 2014