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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01665040




Registration number
NCT01665040
Ethics application status
Date submitted
9/08/2012
Date registered
13/08/2012
Date last updated
6/11/2013

Titles & IDs
Public title
Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain
Scientific title
Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs
Secondary ID [1] 0 0
A5004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient satisfaction with treatment - First of 2 co-primary endpoints. It is measured on a 7-point choice of degree of satisfaction scale.
Timepoint [1] 0 0
90-days post permanent implantation
Primary outcome [2] 0 0
Patient satisfaction with treatment - Second of 2 co-primary endpoints. It is measured on a 7-point choice of degree of satisfaction scale.
Timepoint [2] 0 0
365 days post permanent implantation
Secondary outcome [1] 0 0
Patient satisfaction with treatment - Collected on a 7-point choice of degree of satisfaction scale.
Timepoint [1] 0 0
180-days post permanent implantation
Secondary outcome [2] 0 0
Global impression of change - 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")
Timepoint [2] 0 0
180-days post permanent implantation
Secondary outcome [3] 0 0
Overall pain intensity - Subjects will rate their overall pain on a 0-10 numerical rating scale.
Timepoint [3] 0 0
Baseline through 365-days post permanent implantation
Secondary outcome [4] 0 0
Pain relief responder rate - A "responder" is defined as a subject who reports =50% reduction in baseline pain.
Timepoint [4] 0 0
Baseline through 365-days post permanent implantation
Secondary outcome [5] 0 0
Disability - Disability will be assessed using the Oswestry Disability Index v2.1a
Timepoint [5] 0 0
Baseline through 365-days post permanent implantation
Secondary outcome [6] 0 0
Global impression of change
Timepoint [6] 0 0
Baseline through 365 days post permanent implantation
Secondary outcome [7] 0 0
Pain-related medication use
Timepoint [7] 0 0
Baseline through 365 days post permanent implantation
Secondary outcome [8] 0 0
Percentage overlap of painful areas with stimulation-induced paresthesia (drawings) - Overlap will be assessed using subject-completed drawings of pain and neurostimulation-induced paresthesia (tingling)
Timepoint [8] 0 0
From 90-days through 365-days post permanent implantation
Secondary outcome [9] 0 0
Percentage overlap of painful areas with stimulation-induced paresthesias (verbal) - Overlap will be assessed by subject estimation
Timepoint [9] 0 0
From 90-days through 365 days post permanent implantation
Secondary outcome [10] 0 0
Patient treatment preference - 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.
Timepoint [10] 0 0
Baseline through 365-days post permanent implantation

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Metro Spinal Clinic - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01665040
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Verrills, M.D.
Address 0 0
Metro Spinal Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nic Van Dyck
Address 0 0
Country 0 0
Phone 0 0
31-433568328
Fax 0 0
Email 0 0
Nic.VanDyck@bsci.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01665040