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

Boston Scientific

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Neurostimulation device implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01665040

A5004

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Neurostimulation for chronic pain

Experimental group

Description:

Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs.

Treatment:

Device: Neurostimulation device implantation