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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metro Spinal Clinic, Caulfield, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurostimulation device implantation

Device

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 outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Aug 15, 2012
Registry last updated: Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed