Clinical trial NCT01665040: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: neurostimulation
spinal cord stimulation
peripheral nerve stimulation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation
timeFrame: 90-days post permanent implantation
measure: Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation
timeFrame: 365 days post permanent implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Caulfield
country: Australia
facility: Metro Spinal Clinic
city: Melbourne
country: Australia
facility: Hunter Clinical Research
city: Roeselare
country: Belgium
facility: AZ Delta
city: Madrid
country: Spain
facility: Clinica Universitaria de Navarra
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Quiron Madrid
city: Valencia
country: Spain
facility: H. Clinico Universitario
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Roshini Jain
role: STUDY_DIRECTOR
References: