Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain
CompletedNot applicableNCT01665040
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs
- Conditions
- Interventions
- Device: Neurostimulation device implantation
- Sponsor
- Boston Scientific Corporation
- Start date
- 2012-08
- Primary completion
- 2014-05
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Australia, Belgium, Spain
- Total sites listed
- 7
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01665040