Completed
Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs
What is being tested
Neurostimulation device implantation
Device
Who is being recruted
Neurologic Manifestations+2
+ Pain
+ Signs and Symptoms
Over 18 Years
+17 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: August 2012
Summary
Principal SponsorBoston Scientific Corporation
Last updated: November 19, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorBoston Scientific Corporation
Last updated: November 19, 2020
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Neurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsChronic Pain
Criteria
7 inclusion criteria required to participate
18 years of age or older when written informed consent is obtained
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
Show More Criteria
10 exclusion criteria prevent from participating
Currently on any anticoagulant medications that cannot be discontinued during perioperative period
Failed to achieve satisfactory relief during the stimulation trial phase
Is a high surgical risk
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalNeurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Hunter Clinical Research
Melbourne, AustraliaAZ Delta
Roeselare, BelgiumClinica Universitaria de Navarra
Madrid, SpainCompleted7 Study Centers