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

Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Neurostimulation device implantation

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Caulfield, Australia
    • Metro Spinal Clinic
  • Melbourne, Australia
    • Hunter Clinical Research
• Belgium
  • Roeselare, Belgium
    • AZ Delta
• Spain
  • Madrid, Spain
    • Hospital La Paz
  • Madrid, Spain
    • Clinica Universitaria de Navarra
  • Madrid, Spain
    • Hospital Universitario Quiron Madrid
  • Valencia, Spain
    • H. Clinico Universitario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90-days post permanent implantation
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.	365 days post permanent implantation

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2012
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: August 9, 2012
• First Submitted That Met QC Criteria: August 13, 2012
• First Posted (ESTIMATE): August 15, 2012

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: spinal cord stimulation; neurostimulation; peripheral nerve stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Pain, Intractable
• Other Study ID Numbers: A5004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO