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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01665040
Registration number
NCT01665040
Ethics application status
Date submitted
9/08/2012
Date registered
15/08/2012
Date last updated
19/11/2020
Titles & IDs
Public title
Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain
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Scientific title
Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs
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Secondary ID [1]
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A5004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Pain
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Condition category
Condition code
Neurological
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Other neurological disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Neurostimulation device implantation
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.
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation
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Assessment method [1]
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Proportion of subjects satisfied with treatment at 90 days post-IPG implantation, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.
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Timepoint [1]
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90-days post permanent implantation
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Primary outcome [2]
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Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation
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Assessment method [2]
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Proportion of subjects in a sub-group utilizing more than 2 IPG ports at 365 Days post-IPG implantation satisfied with treatment, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.
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Timepoint [2]
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365 days post permanent implantation
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2014
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Metro Spinal Clinic - Caulfield
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Recruitment hospital [2]
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Hunter Clinical Research - Melbourne
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Recruitment postcode(s) [1]
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- Caulfield
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Recruitment postcode(s) [2]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Roeselare
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Country [2]
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Spain
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State/province [2]
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Madrid
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Country [3]
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Spain
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State/province [3]
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boston Scientific Corporation
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01665040
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Roshini Jain
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Address
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Boston Scientific Neuromodulation Corporation
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01665040
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