Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain
This study is currently recruiting participants.
Verified August 2012 by Boston Scientific Corporation
Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01665040
First received: August 9, 2012
Last updated: August 14, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Pain |
Device: Neurostimulation device implantation |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs |
Resource links provided by NLM:
Further study details as provided by Boston Scientific Corporation:
Primary Outcome Measures:
- Patient satisfaction with treatment [ Time Frame: 90-days post permanent implantation ] [ Designated as safety issue: No ]First of 2 co-primary endpoints. It is measured on a 7-point choice of degree of satisfaction scale.
- Patient satisfaction with treatment [ Time Frame: 365 days post permanent implantation ] [ Designated as safety issue: No ]Second of 2 co-primary endpoints. It is measured on a 7-point choice of degree of satisfaction scale.
Secondary Outcome Measures:
- Patient satisfaction with treatment [ Time Frame: 180-days post permanent implantation ] [ Designated as safety issue: No ]Collected on a 7-point choice of degree of satisfaction scale.
- Global impression of change [ Time Frame: 180-days post permanent implantation ] [ Designated as safety issue: No ]Global Impression of Change (GIC) will be assessed by patients, investigators and caregivers. GIC is a comparison to baseline and will be evaluated by rating the global impression of change using a seven-point scale: ("very much improved" to "marked worsening")
- Overall pain intensity [ Time Frame: Baseline through 365-days post permanent implantation ] [ Designated as safety issue: No ]Subjects will rate their overall pain on a 0-10 numerical rating scale.
- Pain relief responder rate [ Time Frame: Baseline through 365-days post permanent implantation ] [ Designated as safety issue: No ]A "responder" is defined as a subject who reports ≥50% reduction in baseline pain.
- Disability [ Time Frame: Baseline through 365-days post permanent implantation ] [ Designated as safety issue: No ]Disability will be assessed using the Oswestry Disability Index v2.1a
- Global impression of change [ Time Frame: Baseline through 365 days post permanent implantation ] [ Designated as safety issue: No ]
- Pain-related medication use [ Time Frame: Baseline through 365 days post permanent implantation ] [ Designated as safety issue: No ]
- Percentage overlap of painful areas with stimulation-induced paresthesia (drawings) [ Time Frame: From 90-days through 365-days post permanent implantation ] [ Designated as safety issue: No ]Overlap will be assessed using subject-completed drawings of pain and neurostimulation-induced paresthesia (tingling)
- Percentage overlap of painful areas with stimulation-induced paresthesias (verbal) [ Time Frame: From 90-days through 365 days post permanent implantation ] [ Designated as safety issue: No ]Overlap will be assessed by subject estimation
- Patient treatment preference [ Time Frame: Baseline through 365-days post permanent implantation ] [ Designated as safety issue: No ]Subjects who end up utilizing the full capacity of the implantable system will compare treatment from baseline through 90-days post permanent implantation with treatment from 90-days through 365-days post permanent implantation.
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Neurostimulation for chronic pain
Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs.
|
Device: Neurostimulation device implantation
Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial. Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665040
Contacts
| Contact: Ann Van Passel | 32- 473- 660028 | Ann.VanPassel@bsci.com |
Locations
| Australia, Victoria | |
| Metro Spinal Clinic | Recruiting |
| Melbourne, Victoria, Australia | |
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
| Principal Investigator: | Paul Verrills, M.D. | Metro Spinal Clinic |
More Information
No publications provided
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT01665040 History of Changes |
| Other Study ID Numbers: | A5004 |
| Study First Received: | August 9, 2012 |
| Last Updated: | August 14, 2012 |
| Health Authority: | Australia: National Health and Medical Research Council |
Keywords provided by Boston Scientific Corporation:
|
neurostimulation spinal cord stimulation peripheral nerve stimulation |
Additional relevant MeSH terms:
|
Pain, Intractable Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013