N/A
N=40
Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT01665040 ↗Enrolled (actual)
40
Serious AEs
27.5%
Results posted
Jan 2019
Primary outcome: Primary: Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation — 32 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neurostimulation device implantation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation |
32 | — |
| PRIMARY Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation |
21 | — |
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
Data sourced from ClinicalTrials.gov (NCT01665040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.